title: Effect of a Probiotic Infant Formula on Infections in Child Care Centers: Comparison of Two Probiotic Agents Tolerance and safety of Lactobacillus paracasei ssp. paracasei in combination with Bifidobacterium animalis ssp. lactis in a prebiotic-containing infant formula: a randomised controlled trial. Early supplementation of prebiotic oligosaccharides protects formula-fed infants against infections during the first 6 months of life. Assessment of the safety, tolerance, and protective effect against diarrhea of infant formulas containing mixtures of probiotics or probiotics and prebiotics in a randomized controlled trial. Early dietary intervention with a mixture of prebiotic oligosaccharides reduces the incidence of allergic manifestations and infections during the first two years of life. Long-term consumption of infant formulas containing live probiotic bacteria: tolerance and safety. Effects of infant formula containing a mixture of galacto- and fructo-oligosaccharides or viable Bifidobacterium animalis on the intestinal microflora during the first 4 months of life. “Minor” feeding problems during the first months of life: effect of a partially hydrolysed milk formula containing fructo‐ and galacto‐oligosaccharides The clinical effect of a new infant formula in term infants with constipation: a double-blind, randomized cross-over trial A mixture of prebiotic oligosaccharides reduces the incidence of atopic dermatitis during the first six months of age Dosage-Related Bifidogenic Effects of Galacto- and Fructooligosaccharides in Formula-Fed Term Infants Probiotic Intervention in the First Months of Life: Short-Term Effects on Gastrointestinal Symptoms and Long-Term Effects on Gut Microbiota Safety of supplementing infant formula with long-chain polyunsaturated fatty acids and Bifidobacterium lactis in term infants: a randomised controlled trial. Probiotics in the management of atopic eczema Acidic Oligosaccharides from Pectin Hydrolysate as New Component for Infant Formulae: Effect on Intestinal Flora, Stool Characteristics, and pH Low level of galacto-oligosaccharide in infant formula stimulates growth of intestinal Bifidobacteria and Lactobacilli. Colon Microflora in Infants Fed Formula with Galacto- and Fructo-Oligosaccharides: More Like Breast-Fed Infants Acidified Milk Formula Supplemented With Bifidobacterium lactis: Impact on Infant Diarrhea in Residential Care Settings Safety and Tolerance of a Probiotic Formula in Early Infancy Comparing Two Probiotic Agents: A Pilot Study The effect of early nutritional supplementation with a mixture of probiotic, prebiotic, fiber and micronutrients in infants with acute diarrhea in Indonesia. Pro- and Prebiotic Supplementation Induces a Transient Reduction in Hemoglobin Concentration in Infants Probiotics and prebiotics in gastrointestinal disorders Effect of a fermented infant formula containing viable bifidobacteria on the fecal flora composition and pH of healthy full-term infants. A formula containing galacto- and fructo-oligosaccharides prevents intestinal and extra-intestinal infections: an observational study. Dietary supplementation with lactobacilli and bifidobacteria is well tolerated and not associated with adverse events during late pregnancy and early infancy. A Randomized Formula Controlled Trial of Bifidobacterium lactis and Streptococcus thermophilus for Prevention of Antibiotic-Associated Diarrhea in Infants Growth during the first 6 months of life in infants using formula enriched with Lactobacillus rhamnosus GG: double-blind, randomized trial. Clinical evaluation of a new starter formula for infants containing live Bifidobacterium longum BL999 and prebiotics. Effects of probiotic or prebiotic supplemented milk formulas on fecal microbiota composition of infants. Supplementation of milk formula with galacto-oligosaccharides improves intestinal micro-flora and fermentation in term infants. The effect of a prebiotic supplemented formula on growth and stool microbiology of term infants. Effects of a new mixture of prebiotics on faecal flora and stools in term infants Term Infants Fed Formula Supplemented With Selected Blends of Prebiotics Grow Normally and Have Soft Stools Similar to Those Reported for Breast-fed Infants Effect of bifidobacterium Bb12 with or without Streptococcus thermophilus supplemented formula on nutritional status. Long-term Colonization of a Lactobacillus plantarum Synbiotic Preparation in the Neonatal Gut Faecal SIgA secretion in infants fed on pre- or probiotic infant formula. Effects on Faecal Microbiota of Dietary and Acidic Oligosaccharides in Children During Partial Formula Feeding Long-Term Safety and Impact on Infection Rates of Postnatal Probiotic and Prebiotic (Synbiotic) Treatment: Randomized, Double-Blind, Placebo-Controlled Trial Urinary D-Lactate Excretion in Infants Receiving Lactobacillus johnsonii with Formula Effect of prebiotic galacto-oligosaccharide, long-chain fructo-oligosaccharide infant formula on serum cholesterol and triacylglycerol levels. Probiotics and prebiotic galacto-oligosaccharides in the prevention of allergic diseases: a randomized, double-blind, placebo-controlled trial.
abstract: Objective . To investigate the effect of 2 different species of probiotics in preventing infections in infants attending child care centers . Methods . A double-blind , placebo-controlled , r and omized trial was conducted from December 1 , 2000 , to September 30 , 2002 , at 14 child care centers in the Beer-Sheva area of Israel in healthy term infants 4 to 10 months old . Infants were assigned r and omly to formula supplemented with Bifidobacterium lactis ( BB-12 ) , Lactobacillus reuteri ( American Type Culture Collection 55730 ) , or no probiotics . Duration of feeding , including follow-up , for each participant was 12 weeks . All infants were fed only the assigned formula and were not breastfed due to parental decision before recruitment to the study . Probiotic or prebiotic food products or supplements were not allowed . Main outcome measures were number of days and number of episodes with fever ( > 38 ° C ) and number of days and number of episodes with diarrhea or respiratory illness . Results . Participants ( n = 201 ) were similar regarding gestational age , birth weight , gender , and previous breastfeeding . The controls ( n = 60 ) , compared with those fed B lactis ( n = 73 ) or L reuteri ( n = 68 ) , had significantly more febrile episodes ( mean [ 95 % confidence interval ] : 0.41 [ 0.28–0.54 ] vs 0.27 [ 0.17–0.37 ] vs 0.11 [ 0.04–0.18 ] , respectively ) . The controls also had more diarrhea episodes ( 0.31 [ 0.22–0.40 ] vs 0.13 [ 0.05–0.21 ] vs 0.02 [ 0.01–0.05 ] , respectively ) and episodes of longer duration ( 0.59 [ 0.34–0.84 ] vs 0.37 [ 0.08–0.66 ] vs 0.15 [ 0.12–0.18 ] days , respectively ) . The L reuteri group , compared with BB-12 or controls , had a significant decrease of number of days with fever , clinic visits , child care absences , and antibiotic prescriptions . Rate and duration of respiratory illnesses did not differ significantly between groups . Conclusions . Child care infants fed a formula supplemented with L reuteri or B lactis had fewer and shorter episodes of diarrhea , with no effect on respiratory illnesses . These effects were more prominent with L reuteri , which was also the only supplement to improve additional morbidity parameters The addition of probiotics to infant formula has been shown to be an efficient way to increase the number of beneficial bacteria in the intestine in order to promote a gut flora resembling that of breast-fed infants . The objective of the present study was to evaluate the safety and tolerance of a combination of two probiotic strains in early infancy . A group of 126 newborns were r and omised to receive a prebiotic-containing starter formula supplemented with Lactobacillus paracasei ssp . paracasei and Bifidobacterium animalis ssp . lactis or the same formula without probiotics for the first 3 months of life . A total of eighty infants continued the study until they were aged 6 months .  Growth measurements were taken monthly at healthy baby clinics . Diaries were used to monitor behaviour , infections , use of antibiotics , as well as stool characteristics . Normal growth occurred in all infants and no statistically significant differences were detected between the probiotics group and the control group for gain in weight , length and head circumference . Infants in the probiotics group produced softer and more frequent stools during the first 3 months of life . No differences were found in crying and sleeping hours , number of parent-diagnosed infections , antibiotic use , visits to the general practitioner and number of adverse events . The use of a prebiotic-containing starter formula supplemented with L. paracasei ssp . paracasei and B. animalis ssp . lactis in early infancy is safe , well tolerated and has no adverse effects on growth and infant behaviour A mixture of neutral short chain galactooligosaccharides and long chain fructo-oligosaccharides ( scGOS/lcFOS ) has been shown to have prebiotic and immunomodulatory effects comparable to human milk oligosaccharides . This can be translated into clinical practice as a potential to prevent infections and allergy . The hypothesis of this study was that this specific prebiotic mixture could have a preventive effect against infections during the first 6 mo of life . In a prospect i ve , r and omized , double-blind , placebo-controlled trial , healthy term infants with a parental history of atopy were fed either prebiotic-supplemented ( 8 g/L scGOS/lcFOS ) or placebo-supplemented ( 8 g/L maltodextrin ) hypoallergenic formula during the first 6 mo of life . The primary outcome measures were infectious episodes , number of infections requiring antibiotics , and incidence of infections . During the study period , infants in the scGOS/lcFOS group had fewer episodes of all types of infections combined ( P = 0.01 ) . They also tended to have fewer upper respiratory tract infection episodes ( P = 0.07 ) and fewer infections requiring antibiotic treatment ( P = 0.10 ) . Similarly , the cumulative incidence of recurring infections was significantly lower in the scGOS/lcFOS group . The cumulative incidence of any recurring infection and recurring respiratory infections was 3.9 and 2.9 % in the scGOS/lcFOS group and 13.5 and 9.6 % in the placebo group , respectively ( P < 0.05 ) . Oligosaccharide prebiotics reduced the number of infectious episodes and the incidence of recurring , particularly respiratory , infections during the first 6 mo of life . Although the exact mechanism of action is under investigation , it is very likely that the immune modulating effect of this prebiotic mixture through intestinal flora modification is the principal mechanism for the observed infection prevention early in life BACKGROUND Probiotics and prebiotics are considered to be beneficial to the gastrointestinal health of infants . OBJECTIVE The objective was to evaluate infant formulas containing probiotics and synbiotics ( combinations of probiotics and prebiotics ) for safety and tolerance . DESIGN In a prospect i ve , controlled , double-blind , r and omized trial , healthy full-term infants were exclusively fed a control formula or study formulas containing Bifidobacterium longum BL999 ( BL999 ) + Lactobacillus rhamnosus LPR ( LPR ) , BL999 + LPR + 4 g/L of 90 % galactooligosaccharide/10 % short-chain fructooligosaccharide ( GOS/SCFOS ) , or BL999 + Lactobacillus paracasei ST11 ( ST11 ) + 4 g/L GOS/SCFOS from < or = 2 to 16 wk of age ( treatment period ) . Safety and tolerance were assessed based on weight gain during the treatment period ( primary outcome ) as well as recumbent length , head circumference , digestive tolerance , and adverse events ( secondary outcomes ) , which were evaluated at 2 , 4 , 8 , 12 , 16 , and 52 wk of age . RESULTS Two hundred eighty-four infants were enrolled . During the treatment period , difference in mean weight gain between control and study formula groups in both the intention-to-treat and per- protocol population s were within the predefined equivalence boundaries of + /-3.9 g/d , indicating equivalent weight gain . Secondary outcomes did not show significant differences between groups during the treatment period . CONCLUSION Infants fed formulas containing probiotics or synbiotics show a similar rate in weight gain compared with those fed a control formula and tolerate these formulas well A mixture of neutral short-chain galactooligosaccharides ( scGOS ) and long-chain fructooligosaccharides ( lcFOS ) has been shown to reduce the incidence of atopic dermatitis ( AD ) and infectious episodes during the first 6 mo of life . This dual protection occurred through the intervention period . The present study evaluated if these protective effects were lasting beyond the intervention period . In a prospect i ve , r and omized , double-blind , placebo-controlled design , healthy term infants with a parental history of atopy were fed either a prebiotic-supplemented ( 8 g/L scGOS/lcFOS ) or placebo-supplemented ( 8 g/L maltodextrin ) hypoallergenic formula during the first 6 mo of life . Following this intervention period , blind follow-up continued until 2 y of life . Primary endpoints were cumulative incidence of allergic manifestations . Secondary endpoints were number of infectious episodes and growth .  Of 152 participants , 134 infants ( 68 in placebo , 66 in intervention group ) completed the follow-up . During this period , infants in the scGOS/lcFOS group had significantly lower incidence of allergic manifestations . Cumulative incidences for AD , recurrent wheezing , and allergic urticaria were higher in the placebo group , ( 27.9 , 20.6 , and 10.3 % , respectively ) than in the intervention group ( 13.6 , 7.6 , and 1.5 % ) ( P < 0.05 ) . Infants in the scGOS/lcFOS group had fewer episodes of physician-diagnosed overall and upper respiratory tract infections ( P < 0.01 ) , fever episodes ( P < 0.00001 ) , and fewer antibiotic prescriptions ( P < 0.05 ) . Growth was normal and similar in both groups . Early dietary intervention with oligosaccharide prebiotics has a protective effect against both allergic manifestations and infections . The observed dual protection lasting beyond the intervention period suggests that an immune modulating effect through the intestinal flora modification may be the principal mechanism of action BACKGROUND Nonpathogenic live bacteria are consumed as food by many children , particularly in the form of yogurt . The tolerance and safety of long-term consumption of specific types and strains of probiotic bacteria are not well documented . OBJECTIVE The goal was to evaluate tolerance to formulas containing 2 levels of probiotic supplementation and effects on growth , general clinical status , and intestinal health in free-living healthy infants . DESIGN This was a prospect i ve , double-blind , r and omized , placebo-controlled study of healthy infants aged 3 - 24 mo . Infants were assigned to receive a st and ard milk-based formula containing 1 x 10(7 ) colony-forming units (CFU)/g each of Bifidobacterium lactis and Streptococcus thermophilus , formula containing 1 x 10(6 ) CFU/g each of B. lactis and S. thermophilus , or unsupplemented formula . Clinical outcomes included formula intake , gastrointestinal tolerance , anthropometric measures , daycare attendance , and history of illness . RESULTS One hundred eighteen infants aged ( + /- SD ) 7.0 + /- 2.9 mo at enrollment consumed formula for 210 + /- 127 d. There were no significant differences in age , sex , formula consumption , or length of study between groups . The supplemented formulas were well accepted and were associated with a lower frequency of reported colic or irritability ( P < 0.001 ) and a lower frequency of antibiotic use ( P < 0.001 ) than was the unsupplemented formula . There were no significant differences between groups in growth , health care attention seeking , daycare absenteeism , or other health variables . CONCLUSION Long-term consumption of formulas supplemented with B. lactis and S. thermophilus was well tolerated and safe and result ed in adequate growth , reduced reporting of colic or irritability , and a lower frequency of antibiotic use Adding prebiotics or probiotics to infant formula to improve the intestinal flora of formula-fed infants is considered to be a major innovation . Several companies have brought relevant formulations onto the market . However , comparative data on the effects of pre- and probiotics on the intestinal microflora of infants are not available . The present study aim ed to compare the effects of infant formula containing a mixture of galacto- and fructo-oligosaccharides or viable Bifidobacterium animalis on the composition and metabolic activity of the intestinal microflora . Before birth , infants were r and omised and double blindly allocated to one of three formulas . The prebiotic ( GOS/FOS ) group ( n 19 ) received regular infant formula supplemented with a mixture of galacto-oligosaccharides and fructo-oligosaccharides ( 6 g/l ) . The probiotic ( Bb-12 ) group ( n 19 ) received the same formula supplemented with 6.0x10(10 ) viable cells of B. animalis per litre . The st and ard group ( n 19 ) received non-supplemented regular formula .  A group of sixty-three breast-fed infants was included as a reference group . Faecal sample s were taken at postnatal day 5 and 10 , and week 4 , 8 , 12 and 16 . Compared with the groups fed Bb-12 and st and ard formula , the GOS/FOS formula group showed higher faecal acetate ratio ( 69.7 % ( sem 2.7 ) , 69.9 % ( sem 3.9 ) and 82.2 % ( sem 5.3 ) ; P<0.05 ) and lactate concentration ( 11.3 ( sem 7.9 ) , 3.1 ( sem 2.3 ) and 34.7 ( sem 10.7 ) mmol/kg faeces ) and lower pH ( 6.6 ( sem 0.2 ) , 7.1 ( sem 0.2 ) and 5.6 ( sem 0.2 ) ; P<0.05 ) at 16 weeks . Differences in percentage of bifidobacteria between the GOS/FOS ( 59.2 % ( sem 7.7 ) ) , Bb-12 ( 52.7 % ( sem 8.0 ) ) and the st and ard ( 51.8 % ( sem 6.4 ) ) groups were not statistically significant at 16 weeks . Feeding infants GOS/FOS formula result ed in a similar effect on metabolic activity of the flora as in breast-fed infants . In the Bb-12 group , composition and metabolic activity of the flora were more similar to those of the st and ard group Background : Colic , regurgitation and constipation are common feeding problems in formula‐fed infants that might benefit from dietary treatment . A formula containing fructo‐ and galacto‐oligosaccharides , partially hydrolysed proteins , low levels of lactose and palmitic acid in the β position and higher density has been tested to reduce the occurrence of these symptoms . The aim of this prospect i ve study was to describe the effects of such a formula in infants with minor gastrointestinal disorders . Methods : An observational prospect i ve trial involving practising Italian paediatricians was performed .  Formula fed‐infants up to 90 d of age with minor gastrointestinal problems such as infantile colics and /or regurgitation and /or constipation were enrolled in the study from January 2001 to May 2001 . The study was completed within 14 d of treatment . On days 1 , 7 and 14 the infants were visited by the paediatricians . Parents were given a structured diary to record daily episodes of colic , regurgitation and type and number of stools . Results : Of the 932 infants enrolled , 604 completed the study . Of the 214 infants with colic , 169 ( 79 % ) demonstrated a reduction in frequency of colic from 4.1 ± 2.0 per day at the beginning of the study to 2.0 ± 1.8 at the end of the study ( I.C. 95 % : 1.72–2.39 ; p < 0.005 ) . A reduction in the number of episodes of colic of 1.8 per day at the beginning of the study ( I.C. 95 % : 1.49–2.11 ; p < 0.05 ) was recorded between day 1 and day 7 , and of 0.26 ( I.C. 95 % : 0.15–0.37 ; p < 0.05 ) between day 7 and day 14 . Of the 201 infants with regurgitation problems , 141 ( 70 % ) demonstrated a reduction of frequency of the symptoms from 4.2 ± 2.0 per day at the beginningof the study to 2.1 ± 2.2 at the end of the study ( I.C. 95 % : 1.75–2.35 ; p < 0.005 ) . A reduction of 1.87 in the number of regurgitation episodes was reported between day 1 and day 7 ( I.C. 95 % : 1.57–2.16 ; p < 0.05 ) and of 0.18 ( I.C. 95 % : 0.06–0.31 ; p < 0.05 ) between day 7 and day 14 . Of the 232 infants with constipation , 147 ( 63 % ) demonstrated an increase in the daily number of stools of 0.42 ( I.C. 95 % : 0.5–0.3 ; p < 0.005 ) . An increase in stool frequency of 0.41 ( I.C. 95 % : 0.51–0.23 ; p < 0.05 ) was reported between day 1 and day 7 , and of 0.04 ( I.C. 95 % : 0.22–0.14 ; p= ns ) between day 7 and day 14 . Parents’evaluation of the formula was 7.9 ± 1.8 ( score 0–10 ) ; 550 parents ( 91 % ) gave a positive judgement ( score > 6 ) . The evaluation by the paediatricians of the improvement in symptoms after the treatment was 8.2 ± 1.5 ; 574 ( 95 % ) a positive effect ( score > 6 ) Background Nutrilon Omneo ( new formula ; NF ) contains high concentration of sn-2 palmitic acid , a mixture of prebiotic oligosaccharides and partially hydrolyzed whey protein . It is hypothesized that NF positively affects stool characteristics in constipated infants . Methods Thirty-eight constipated infants , aged 3–20 weeks , were included and r and omized to NF ( n = 20 ) or a st and ard formula ( SF ; n = 18 ) in period 1 and crossed-over after 3 weeks to treatment period 2 . Constipation was defined by at least one of the following symptoms : 1 ) defecation frequency < 3/week ; 2 ) painful defecation ; 3 ) abdominal or rectal palpable mass . Results Period 1 was completed by 35 infants . A significant increase in defecation frequency ( NF : 3.5 pre versus 5.6/week post treatment ; SF 3.6 pre versus 4.9/week post treatment ) was found in both groups , but was not significantly different between the two formulas ( p = 0.36 ) . Improvement of hard stool consistency to soft stool consistency was found more often with NF than SF , but did not reach statistical significance ( 90 % versus 50 % ; RR , 1.8 ; 95 % CI , 0.9–3.5 ; p = 0.14 ) . No difference was found in painful defecation or the presence of an abdominal or rectal mass between the two groups . Twenty-four infants completed period 2 . Only stool consistency was significantly different between the two formulas ( 17 % had soft stools on NF and hard stools on SF ; no infants had soft stools on SF and hard stools on NF , McNemar test p = 0.046 ) . Conclusion The addition of a high concentration sn-2 palmitic acid , prebiotic oligosaccharides and partially hydrolyzed whey protein result ed in a strong tendency of softer stools in constipated infants , but not in a difference in defecation frequency . Formula transition to NF may be considered as treatment in constipated infants with hard stools Background : Oligosaccharides may alter postnatal immune development by influencing the constitution of gastrointestinal bacterial flora . Aims : To investigate the effect of a prebiotic mixture of galacto- and long chain fructo-oligosaccharides on the incidence of atopic dermatitis ( AD ) during the first six months of life in formula fed infants at high risk of atopy . Methods : Prospect i ve , double-blind , r and omised , placebo controlled trial ; 259 infants at risk for atopy were enrolled . A total of 102 infants in the prebiotic group and 104 infants in the placebo group completed the study . If bottle feeding was started , the infant was r and omly assigned to one of two hydrolysed protein formula groups ( 0.8 g/100 ml prebiotics or maltodextrine as placebo ) . All infants were examined for clinical evidence of atopic dermatitis . In a subgroup of 98 infants , faecal flora was analysed . Results : Ten infants ( 9.8 % ; 95 CI 5.4–17.1 % ) in the intervention group and 24 infants ( 23.1 % ; 95 CI 16.0–32.1 % ) in the control group developed AD . The severity of the dermatitis was not affected by diet . Prebiotic supplements were associated with a significantly higher number of faecal bifidobacteria compared with controls but there was no significant difference in lactobacilli counts . Conclusion : Results show for the first time a beneficial effect of prebiotics on the development of atopic dermatitis in a high risk population of infants . Although the mechanism of this effect requires further investigation , it appears likely that oligosaccharides modulate postnatal immune development by altering bowel flora and have a potential role in primary allergy prevention during infancy Background Human milk oligosaccharides have been shown to stimulate selectively the growth of Bifidobacteria and Lactobacilli in the intestine . In this study , the bifidogenic effect of an experimental prebiotic oligosaccharide mixture consisting of low-molecular-weight galactooligosaccharides and high-molecular-weight fructooligosaccharides was analyzed in 90 term infants . Methods Two test formulas were supplemented with either 0.4 g/dL or with 0.8 g/dL oligosaccharides . In the control formula , maltodextrin was used as placebo . At study day 1 and study day 28 , the fecal species , colony forming units ( cfu ) and pH were measured and stool characteristics , growth , and side effects were recorded . Results At study day 1 , the median number of Bifidobacteria did not differ among the groups ( 0.4 g/dL group , mean [ interquartile range ] 8.5 [ 1.9 ] cfu/g ; 0.8 g/dL group , 7.7 [ 6.1 ] cfu/g ; and the placebo group , 8.8 [ 6.1 ] cfu/g ) ( figures in square brackets are interquartile range ) . At the end of the 28-day feeding period , the number of Bifidobacteria was significantly increased for both groups receiving supplemented formulas ( the 0.4 g/dL group , 9.3 [ 4.9 ] cfu/g ; the 0.8 g/dL group , 9.7 [ 0.8 ] cfu/g ) versus the placebo group ( 7.2 [ 4.9 ] cfu/g , P < 0.001 ) . This effect was dose dependent ( 0.4 g/dL versus 0.8 g/dL , P < 0.01 ) . The number of Lactobacilli also increased significantly in both groups fed the supplemented formulas ( versus placebo , P < 0.001 ) , but there was no statistically significant difference between the group fed formula with 0.4 g/dL oligosaccharides and the group fed formula with 0.8 g/dL oligosaccharides . The dosage of supplement significantly influenced the change in fecal pH ( P < 0.05 ) ( placebo , pH 5.5–6.1 ; 0.4 g/dL formula , pH 5.48–5.44 ; 0.8 g/dL formula , pH 5.54–5.19 ) . Slight changes in the stool frequency result ed in a significant difference between the placebo group and the group fed the 0.8 g/dL formula at day 28 ( P < 0.01 ) . Supplementation had a significant dose-dependent influence on stool consistency ( 0.8 g/dL versus placebo , P < 0.0001 ; 0.8 g/dL versus 0.4 g/dL , P < 0.01 ) . Supplementation had no influence on the incidence of side effects ( crying , regurgitation , vomiting ) or growth . Conclusions These data indicate that supplementation of a term infant 's formula with a mixture of galacto- and fructooligosaccharides has a dose-dependent stimulating effect on the growth of Bifidobacteria and Lactobacilli in the intestine and results in softer stool with increasing dosage of supplementation Objectives : To determine whether probiotics administered for 6 months postnatally affect  gastrointestinal symptoms , crying  and the compositional development of the gut microbiota through infancy . Methods : The study comprised of 132 newborns whose mothers were r and omized to receive placebo or Lactobacillus rhamnosus GG ( ATCC 53103 ) before delivery . The treatments of mothers/infants continued for 6 months postnatally . A specific symptom chart was used to monitor gastrointestinal symptoms and infant 's crying during the 7th and the 12th weeks of life . Fluorescent in situ hybridization was used to establish the Bifidobacterium , Lactobacillus/Enterococcus , Bacteroides and Clostridium counts in fecal sample s at 6 , 12 , 18 and 24 months of age . Results : Numbers of different types of stools , vomits and crying time were comparable between the groups during the 7th and the 12th weeks of life . Dominant microbiota consisted of bifidobacteria throughout the study . At 6 months , there were less clostridia in faeces in the placebo compared with the probiotic group ( P = 0.026 ) , whereas after long-term follow-up at 2 years , there were less lactobacilli/enterococci and clostridia in faeces in the probiotic group than in the placebo group ( P = 0.011 and P = 0.032 , respectively ) , reflecting the impact of clostridia as a marker of microbiota succession in healthy infants . Conclusions : Probiotic administration in the first months of life was well tolerated and did not significantly interfere with long-term composition or quantity of gut microbiota Probiotics and long-chain PUFA ( LC-PUFA ) may be beneficial supplements for infants who are not breast-fed . The aim of the present study is to evaluate the safety of an infant formula containing the LC-PUFA DHA and arachidonic acid ( AA ) and the probiotic Bifidobacterium lactis by comparing the growth rate of infants fed the supplemented and unsupplemented formulas . One hundred and forty-two healthy , term infants were enrolled in a single-centre , r and omised , double-blind , controlled , parallel-group trial , and allocated to receive either st and ard or probiotic and LC-PUFA-containing experimental formulas . The infants were fed with their assigned formulas for 7 months . The primary outcome ( weight gain ) and the secondary outcomes ( length , head circumference and formula tolerance ) were measured throughout the study . LC-PUFA status was assessed at 4 months of age and immune response to childhood vaccines was measured at 7 months of age . There was no significant difference in growth between the two groups . The 90 % CI for the difference in mean weight gain was - 0.08 , 3.1 g in the intention-to-treat population and 0.1 - 3.8 g in the per protocol population , which lay within the predefined boundaries of equivalence , - 3.9 - 3.9 . There were no significant differences in mean length and head circumference . DHA and AA concentrations were higher in infants in the experimental formula group compared with the control formula group . No influence of the supplements on the response to vaccines was observed . Growth characteristics of term infants fed the starter formula containing a probiotic and LC-PUFA were similar to st and ard formula-fed infants Over the last two decades the incidence of allergic diseases has increased in industrialized countries , and consequently new approaches have to be explored Objectives : To come even closer to the functional composition of human milk , acidic oligosaccharides ( AOS ) from pectin were added to well known neutral prebiotics ( galacto-oligosaccharides ( GOS ) and long-chain fructo-oligosaccharides ( FOS ) ) . The effect of AOS and GOS/FOS/AOS on intestinal flora , stool characteristics as well as acceptance and tolerance was investigated . Methods : Human milk contains 75 % to 85 % neutral and 15 % to 25 % acidic oligosaccharides . In this prospect i ve , r and omized , double blind study , a mixture of 80 % neutral oligosaccharides ( from long-chain galacto- and long-chain fructo-oligosaccharides ) with 20 % acidic oligosaccharides derived from pectin hydrolysis was investigated . Forty-six term infants were fed a st and ard formula supplemented with either maltodextrin as control ( n = 15 ) , or with 0.2 g acidic oligosaccharides ( n = 16 ) , or with the latter plus 0.6 g neutral oligosaccharides ( mixture of galacto- and fructo-oligosaccharides ; n = 15 ) . Fecal flora using plating technique and pH were measured . Stool characteristics and possible side effects ( crying , vomiting , and regurgitation ) were recorded . Results : There was no difference in the bifidobacteria counts between the control and the group supplemented with acidic oligosaccharides alone ( 8.75 ± 0.50 vs. 8.58 ± 0.94 log colony forming units [CFU]/g stool ) . In infants fed the combination of acidic and neutral oligosaccharides , bifidobacteria were increased ( 9.61 ± 0.70 log CFU/g stool ; P < 0.01 ) . The same pattern was observed with lactobacilli . Stool consistency was softest in infants fed the complete oligosaccharide mixture , but also in those fed formula supplemented with acidic oligosaccharides alone , the stool consistency was significantly softer compared with the control group . Fecal pH increased in the controls , remained constant in acidic oligosaccharides alone , and decreased in the complete mixture of oligosaccharides group . Conclusion : There was no difference in growth , crying , vomiting , and regurgitation patterns between the groups . In summary , acidic oligosaccharides from pectin hydrolysate are well tolerated as ingredient in infant formulae but do not affect intestinal microecology AIM To investigate the effect of a new infant formula supplemented with a low level ( 0.24 g/100 mL ) of galacto-oligosaccharide ( GOS ) on intestinal micro-flora ( Bifidobacteria , Lactobacilli and E. coli ) and fermentation characteristics in term infants , compared with human milk and a st and ard infant formula without GOS . METHODS Term infants ( n = 371 ) were approached in this study in three hospitals of China . All infants started breast-feeding . Those who changed to formula-feeding within 4 wk after birth were r and omly assigned to one of the two formula groups . Growth and stool characteristics , and side effects that occurred in recruited infants were recorded in a 3-mo follow-up period . Fecal sample s were collected from a sub population of recruited infants for analysis of intestinal bacteria ( culture technique ) , acetic acid ( gas chromatography ) and pH ( indicator strip ) . RESULTS After 3 mo , the intestinal Bifidobacteria , Lactobacilli , acetic acid and stool frequency were significantly increased , and fecal pH was decreased in infants fed with the GOS-formula or human milk , compared with those fed with the formula without GOS . No significant differences were observed between the GOS formula and human milk groups . Supplementation with GOS did not influence the incidence of crying , regurgitation and vomiting . CONCLUSION A low level of GOS ( 0.24 g/100 mL ) in infant formula can improve stool frequency , decrease fecal pH , and stimulate intestinal Bifidobacteria and Lactobacilli as in those fed with human milk Objectives : The intestinal flora of breast-fed infants is generally dominated by Bifidobacteria . We aim ed to investigate whether an infant formula supplemented with galacto-oligosaccharides and fructo-oligosaccharides ( GOS/FOS ) is able to establish a bifido-dominant microflora , not only in numbers but also with respect to the metabolic activity in the colon . Methods : Two groups of infants fed infant formula with 0.8 g/100 ml GOS/FOS in a ratio of 9:1 ( OSF group ) , or control formula ( SF group ) were evaluated in a r and omised , double blind , placebo controlled intervention study . A breast-fed group was studied in parallel . At study onset and after 4 and 6 weeks , faecal sample s were examined for the number of bifidobacteria , pH , short chain fatty acids and lactate . Results : After 6 weeks , the mean proportion of bifidobacteria was significantly higher in the OSF group ( 59.6 % versus 49.5 % in the SF group ; P < 0.05 ) . Compared with controls , infants in the OSF group had a lower stool mean pH and an increased proportion of acetate and a decreased proportion of propionate . The mean pH in the OSF and SF groups were 5.7 and 6.3 , respectively ( P < 0.001 ) . Conclusions : The addition of the prebiotic GOS/FOS mixture to an infant formula has a stimulating effect on the growth of bifidobacteria and on the metabolic activity of the total intestinal flora . The changes in short chain fatty acids , lactate and pH in the prebiotic group represent a fermentation profile that is closer to that observed in breast-fed infants compared to infants fed control formula Objectives Probiotics may be useful in preventing acute infectious diarrhea .  Bifidobacteria are particularly attractive as probiotics agent because they constitute the predominant colonic flora of breastfed infants and are thought to play a role in the decreased incidence of diarrhea in breastfed infants . Methods This was a multicenter , double-blind , controlled study to evaluate the efficacy of a milk formula supplemented with viable Bifidobacterium lactis strain Bb 12 ( BbF ) in the prevention of acute diarrhea in infants younger than 8 months living in residential nurseries or foster care centers . Results Ninety healthy children received either the BbF or a conventional formula ( CF ) daily . The mean duration of the stay in the residential center was similar ( 137 v 148 days ) . At enrollment , there were no differences between the two groups with respect to age ( 3.7 ± 2.1 months ) , gender , anthropometric data , history of allergy or gastrointestinal disease , frequency of breast-feeding in the neonatal period or timing of introduction of solid food . Altogether , 28.3 % of the BbF infants  had diarrhea during the study compared with 38.7 % of controls ( NS ) . There was a statistically insignificant trend for shorter episodes of diarrhea in the BbF group ( 5.1 ± 3.3 days v 7 ± 5.5 days , NS ) . The number of days with diarrhea was 1.15 ± 2.5 in the BbF group with a daily probability of diarrhea of 0.84 versus 2.3 ± 4.5 days and 1.55 , respectively , in the CF group ( P = 0.0002 and 0.0014 ) . Feeding infants with the BbF reduced their risk of getting diarrhea by a factor of 1.9 ( range , 1.33–2.6 ) . Analysis of the cumulative incidence of diarrheal episodes showed a trend that the first onset of diarrhea occurred later in the BbF group . Conclusion These results provide some evidence that viable Bifidobacterium lactis strain Bb 12 , added to an acidified infant formula , has some protective effect against acute diarrhea in healthy children Objective : To compare the safety and tolerance of two formulas , supplemented with different probiotic agents , in early infancy . Design : Prospect i ve r and omized placebo-controlled trial . Setting : Clinics of a University Medical Center . Subjects : Full-term healthy infants aged less than 4 months . Intervention : Infants were r and omly assigned for 4 weeks to a st and ard milk-based formula supplemented with either Bifidobacterium lactis ( BB-12 ) , Lactobacillus reuteri ( ATCC 55730 ) or a probiotics-free formula . Measures of Outcome : Growth parameters , daily characteristics of feeding , stooling and behavior , and side effects . Results : Fifty-nine infants , aged 3–65 days , were included . Subjects in all three groups were similar at entry in terms of gestational age , birth weight , sex , growth parameters and breast feeding rate prior to the study . The supplemented formulas were well accepted and did not reveal any adverse effects . A comparison of growth parameters , and variables of feeding , stooling and crying and irritability did not reveal any significant differences between groups . Conclusions : The use of formula supplemented with either Lactobacillus reuteri or Bifidobacterium lactis in early infancy , was safe , well tolerated and did not adversely affect growth , stooling habits or infant behavior A r and omized double blind clinical trial was conducted to assess the efficacy of a special infant formula containing Lactobacillus rhamnosus LMG P-22799 ( probiotic : 5 x 10(8 ) CFU/100mL ) , inulin ( prebiotic : 0.15 g/100mL ) , dietary fiber ( soy polysaccharides : 0.2 g/100mL ) and increased amounts of zinc+iron ( + 0.4 and + 0.6 mg/100mL , respectively ) as active ingredients for the early dietary management of 58 Indonesian well-nourished male infants aged 3 - 12 months suffering from acute diarrhea with moderate dehydration . After adequate oral rehydration , the patients were r and omly assigned to receive either a low lactose infant formula supplemented with added precooked rice ( 1.5 g/100mL ) with the above active ingredients ( study group ) or a low lactose infant formula with added precooked rice without the above active ingredient supplement ( control group ) . No antibiotic , anti-secretory drug or antiemetic was given at all . Both study and control groups showed similar outcomes for weight gain and stool weight . The duration of diarrhea was significantly shorter in the study group than in the control group ( 1.63 versus 2.45 days ; p<0.05 ; for the study and control group respectively ) . No treatment failure or other side effects were observed during the course of the study . The present study supports the evidence for the efficacy of a special anti-diarrhea infant formula containing probiotic , prebiotic , fiber and iron+zinc after oral rehydration by shortening the duration of infantile diarrhea in developing countries . However , from the results of our study we can not discern the individual contribution of the active ingredients and also not whether they may act independent from each other or in a synergistic way Objectives : Regarding safety , we investigated the effect of prenatal probiotic and 6 months of pro- and prebiotic supplementation of infants on their hematologic values at 6 months and 2 years and factors affecting these values . Patients and Methods : In a prospect i ve r and omized controlled probiotic intervention trial in infants at high risk for allergy , we obtained blood sample s consecutively from 98 infants at 6 months and from 658 children at 2 years to measure hematologic values . We collected fecal sample s at 3 and 6 months to measure immunologic development by calprotectin , α-1-antitrypsin , tumor necrosis factor-α , and immunoglobulin A. Results : At 6 months , infants in the probiotic group had significantly lower hemoglobin ( Hb ) values than did the placebo group , mean ( SD ) : 119.8 g/L ( 6.3 ) versus 123.3 g/L ( 8.4 ) , P = 0.025 . Adjustment for factors that might affect Hb values ( breast-feeding duration , solid-food introduction , and sex ) , revealed no need for adjustment . A significant negative correlation emerged between Hb values at 6 months and fecal calprotectin at age 3 months r = −0.301 , P = 0.009 , which was affected neither by breast-feeding , sex , nor study group . At 2 years , hematologic values in both groups became similar . Conclusions : Probiotics cause a gut mucosal inflammation with decreased Hb values during intervention , corrected after halting the supplementation Purpose of review This review summarizes the clinical efficacy of probiotics and prebiotics in gastrointestinal disorders and examines the mechanisms of action related to their therapeutic effect . Recent findings The demonstration that immune and epithelial cells can discriminate between different microbial species has extended the known mechanism(s ) of action of probiotics beyond simple barrier and antimicrobial effects . It has also confirmed that probiotic bacteria modulate mucosal and systemic immune activity and epithelial function . The progressive unraveling of these mechanisms of action has led to new credence for the use of probiotics and prebiotics in clinical medicine . Level I evidence now exists for the therapeutic use of probiotics in infectious diarrhea in children , recurrent Clostridium difficile – induced infections and postoperative pouchitis . Level II evidence is emerging for the use of probiotics in other gastrointestinal infections , prevention of postoperative bacterial translocation , irritable bowel syndrome , and in both ulcerative colitis and Crohn disease . Nevertheless , one consistent feature has emerged over the past year : Not all probiotic bacteria have similar therapeutic effects . Future clinical trials will need to incorporate this fact into trial planning and design . Summary The use of probiotics and prebiotics as therapeutic agents for gastrointestinal disorders is rapidly moving into the “ mainstream . ” Mechanisms of action explain the therapeutic effects and r and omized ; controlled trials provide the necessary evidence for their incorporation into the therapeutic armamentarium We assessed the growth , tolerance , and acceptability as well as fecal flora composition and stool pH of 20 healthy full-term infants fed with a fermented whey-adapted infant formula containing viable bifidobacteria ( 10(6)/g of powder ) during the first 2 months of life . This fermented infant formula , first biologically acidified by Streptococcus thermophilus and Lactobacillus helveticus , was compared to a whey-adapted , nonacidified , low-phosphate infant formula in a double-blind , r and omized controlled study . The results were compared to a control group ( n = 14 ) of fully breast-fed infants . The fermented whey-adapted formula containing viable bifidobacteria induced a prevalence of colonization with bifidobacteria at 1 month of age similar to that of breast-fed infants ( 12/20 versus 8/14 ) but significantly higher than in the group fed the st and ard infant formula ( 4/20 ) . The mean bacterial count of bifidobacteria was similar in all colonized infants ; however , fecal pH was significantly lower in the breast-fed infants than in the nonacidified bottle-fed infants . This kind of infant formula was well tolerated and promoted a normal growth during the first 2 months BACKGROUND & AIM The addition of prebiotics to infant formula modifies the composition of intestinal microflora . Aim of the study was to test the hypothesis that prebiotics reduce the incidence of intestinal and respiratory infections in healthy infants . METHODS A prospect i ve , r and omized , placebo-controlled , open trial was performed . Healthy infants were enrolled and r and omized to a formula additioned with a mixture of galacto- and fructo-oligosaccharides or to a control formula . The incidence of intestinal and respiratory tract infections and the anthropometric measures were monitored for 12 months . RESULTS Three hundred and forty two infants ( mean age 53.7+/-32.1 days ) were enrolled . The incidence of gastroenteritis was lower in the supplemented group than in the controls ( 0.12+/-0.04 vs. 0.29+/-0.05 episodes/child/12 months ; p=0.015 ) . The number of children with more than 3 episodes tended to be lower in prebiotic group ( 17/60 vs. 29/65 ; p=0.06 ) . The number of children with multiple antibiotic courses/year was lower in children receiving prebiotics ( 24/60 vs. 43/65 ; p=0.004 ) . A transient increase in body weight was observed in children on prebiotics compared to controls during the first 6 months of follow-up . CONCLUSIONS Prebiotic administration reduce intestinal and , possibly , respiratory infections in healthy infants during the first year of age Lactic acid bacteria and bifidobacteria are increasingly being administered to pregnant women and infants with the intention of improving health . Although these organisms have a long record of safe use , it is important to identify any adverse effects in potentially vulnerable population s. In a r and omized , double-blinded , placebo-controlled trial , we evaluated the safety of a bacterial dietary supplement for the prevention of atopy in infants .  Two strains of lactobacilli ( Lactobacillus salivarius CUL61 and Lactobacillus paracasei CUL08 ) and bifidobacteria ( Bifidobacterium animalis subsp . lactis CUL34 and Bifidobacterium bifidum CUL20 ) with a total of 1 x 10(10 ) colony-forming units were administered daily to women during the last month of pregnancy and to infants aged 0 - 6 mo .  Adverse events ( AE ) were classified according to WHO International Statistical Classification of Diseases criteria . Common symptoms were recorded by regular question naires . Baseline characteristics of 220 mother-infant dyads in the treatment and 234 in the placebo group were similar . Compliance with the trial interventions , loss to follow-up , symptoms , drug usage , infant growth , method of feeding , visits to the doctor , and mothers ' assessment of infant health were similar in the 2 groups . Fifteen ( 6.8 % ) mothers and 73 ( 33.2 % ) infants in the treatment group and 21 ( 9.0 % ) mothers and 75 ( 32.1 % ) infants in the placebo group reported AE ( P = 0.49 and P = 0.84 , respectively ) . Severe AE occurred in 18 mothers and 63 infants with a similar frequency in each group . None of the AE were attributed to the intervention . Our findings support the safe use of this consortium of organisms during pregnancy and early infancy Goals : This clinical trial was carried out to determine whether oral treatment with a commercial probiotic formula containing Bifidobacterium lactis and Streptococcus thermophilus would reduce the frequency of  antibiotic-associated diarrhea ( AAD ) in infants . Study : In this double-bind formula controlled study , 80 infants , 6 to 36 months of age , were r and omly assigned to receive a commercial formula containing 107 viable cells of B. lactis and 106viable cells of S. thermophilus at the initiation of antibiotics for a duration of 15 days . The infants were assessed daily for formula intake , stool frequency , and stool consistency for a total duration of 30 days . Seventy-seven infants received  nonsupplemented formula for the entire duration . Results : There was a significant difference in the incidence of AAD in the children receiving probiotic-supplemented formula ( 16 % ) than nonsupplemented formula ( 31 % ) . Conclusions : The present study shows that prevention against AAD in infants was obtained by oral treatment with daily dose of B. lactis and S. thermophilus BACKGROUND Probiotic bacteria have beneficial effects on the immune system and gastrointestinal tract , but the impacts of their long-term consumption on health and growth in early infancy are not well documented . The aim of this study was to evaluate the influence of Lactobacillus rhamnosus GG (LGG)-enriched formula on growth and faecal microflora during the first 6 months of life in normal healthy infants . MATERIAL S AND METHODS One hundred and twenty healthy infants ( up to 2 months ) received LGG-supplemented formula or regular formula in a double-blind , r and omized manner until the age of 6 months . Weight , length and head circumference were measured monthly and transformed into st and ard deviation scores ( SDS ) . Faecal sample s were obtained from a r and om sample of infants ( n=25 ) at entry and at the end of the study . RESULTS One hundred and five infants ( 51 in the LGG group ) completed the study . Children receiving LGG-supplemented formula grew better : their changes in their length and weight SDS ( DeltaSDS ) at the end of the study were significantly higher than those receiving regular formula ( 0.44+/- 0.37 versus 0.07+/- 0.06 , P < 0.01 and 0.44+/- 0.19 versus 0.07+/- 0.06 , P < 0.005 , respectively ) . The LGG group had a significant , higher defecation frequency 9.1+/-2.06 versus 8.0+/- 2.8 ( P<0.05 ) . More frequent colonization with lactobacilli was found in the LGG group , 91 % versus 76 % ( P<0.05 ) at the end of the study . CONCLUSIONS Infants fed with LGG-enriched formula grew better than those fed with regular formula . Further studies are necessary to clarify the mechanism of LGG in infant growth OBJECTIVES The larger number of bifidobacteria in the intestine of breast-fed infants has been associated with their better health compared with formula-fed infants . We assessed the safety and tolerability of an experimental formula containing 2 x 10(7 ) colony-forming units of Bifidobacterium longum BL999 and 4 g/L of a prebiotic mixture containing 90 % galacto-oligosaccharides and 10 % fructo-oligosaccharides . METHODS A 7-mo prospect i ve , r and omized , reference-controlled , double-blinded trial was performed in infants who were not breast fed after the 14th day of birth . One hundred thirty-eight infants were enrolled and assigned to receive the control or experimental formula until they were 112 d old .  Mean weight gain ( primary outcome ) and recumbent length , head circumference , tolerability ( gastrointestinal symptoms ) , and overall morbidity ( secondary outcomes ) were measured at 14 , 28 , 56 , 84 , and 112 d of age . RESULTS Equivalence in mean weight gain between the two groups was shown . The treatment difference in the intention-to-treat and per- protocol population s were within the predefined equivalence boundaries of + /-3.9 g/d . No statistically significant difference in recumbent length , head circumference , or incidence of adverse events was found between the two groups . Infants in the experimental group had fewer incidences of constipation and had stool characteristics that suggest that the experimental formula was tolerated well . Furthermore , these infants showed a trend toward fewer respiratory tract infections . CONCLUSIONS The starter formula containing BL999 and galacto-oligosaccharides/fructo-oligosaccharides is safe and well-tolerated The aim of the study was to evaluate whether supplementation of milk-formulas with prebiotic fructo-oligosaccharides or a probiotic , Lactobacillus johnsonii La1 ( La1 ) , could modulate the composition of the fecal microbiota of formula-fed infants , compared to breastfed ( BF ) infants . Ninety infants close to 4 months of age were r and omized into one of three groups to be blindly assigned to receive for 13 weeks : a ) an infant formula ( Control ) , b ) the same formula with fructo-oligosaccharides ( Prebio ) , or c ) with La1 ( Probio ) . At the end of this period , all infants received the control formula for 2 additional weeks . Twenty-six infants , breastfed throughout the study , were recruited to form group BF . Fecal sample s were obtained upon enrolment and after 7 and 15 weeks . Bacterial population s were assessed with classical culture techniques and fluorescent in situ hybridisation ( FISH ) . Seventy-six infants completed the study . On enrolment , higher counts of Bifidobacterium and Lactobacillus and lower counts of enterobacteria were observed in BF compared to the formula-fed infants ; these differences tended to disappear at weeks 7 and 15 . No major differences for Clostridium , Bacteroides or Enterococcus were observed between the groups or along the follow up . Probio increased fecal Lactobacillus counts ( p<0.001 ) ; 88 % of the infants in this group excreted live La1 in their stools at week 7 but only 17 % at week 15 . Increased Bifidobacterium counts were observed at week 7 in the 3 formula groups , similar to BF infants . These results confirm the presence of higher counts of bifidobacteria and lactobacilli in the microbiota of BF infants compared to formula-fed infants before dietary diversification , and that La1 survives in the infant digestive tract BACKGROUND Oligosaccharides in human milk may protect infants by improving the intestinal micro-flora and fermentation . This study was to investigate effects of  infant formula milk consisting of galacto-oligosaccharide ( GOS ) on intestinal microbial population s and the fermentation characteristics in term infants in comparison with that of human milk . METHODS The test formula ( Frisolac H , Friesl and , Netherl and ) was supplemented with GOS at a concentration of 0.24 g/dl . Human milk and another formula without oligosaccharides ( Frisolac H , Friesl and , Netherl and ) were used as positive and negative control respectively . Growth , stool characteristics , and side effects of the recruited infants were recorded after 3 and 6 months ' follow-up , and the fecal species were collected for the analysis of intestinal micro-flora , short chain fatty acid ( SCFA ) and pH. RESULTS At the end of 3- and 6-month feeding period , intestinal Bifidobacteria and Lactobacilli were significantly increased in infants fed with GOS supplemented formula and human milk when compared with infants fed with negative control formula ; however , there was no statistically significant difference between GOS supplemented formula and human milk groups . Stool characteristics were influenced by the supplement and main fecal SCFA ( acetic ) , and stool frequency were significantly increased in infants fed with GOS supplemented formula and human milk , while the fecal pH was significantly decreased as compared with that of negative control ( P < 0.05 ) . Supplementation had no influence on incidence of side effects ( including crying , regurgitation and vomiting ) . CONCLUSIONS Supplementing infant formula with GOS at a concentration of 0.24 g/dl stimulates the growth of Bifidobacteria and Lactobacilli in the intestine and stool characteristics are similar to in term infants fed with human milk BACKGROUND The intestinal flora of breast-fed infants is generally dominated by bifidobacteria which have beneficial properties . Their presence is due to various compounds of breast milk including prebiotic substances . AIM This prospect i ve , double blind , study compared the growth , acceptability and the proportion of bifidobacteria and clostridia in the stool flora of bottle-fed infants r and omized to receive a formula with a specific mixture of 0.4 g/100 ml prebiotic galacto- and long-chain fructooligosaccharides or the same formula without added prebiotics . METHODS Within 0 - 14 days after birth at term , healthy bottle-fed infants were enrolled to receive either a prebiotic formula or a st and ard formula . At recruitment anthropometric measurements were done . These were repeated at the age of 6 and 12 weeks . Stool sample s were taken at inclusion and at the age of 6 weeks . The number of bifidobacteria and clostridia was determined by fluorescent in situ hybridization . RESULTS There was good tolerance of the prebiotic formula . Somatic growth was similar in the two groups . Stool frequency was significantly higher in the prebiotic group ( P=0.031 ) . Infants in the prebiotic group had also softer stools as compared to the control group ( P=0.026 ) . Baseline values of microorganisms at study entry were similar . The percentage of faecal clostridia at the completion of the study was significantly lower in the prebiotic group ( P=0.042 ) , while the proportion of faecal bifidobacteria was higher in the prebiotic group as compared to the control group . However this difference did not reach statistical significance ( P=0.262 ) . The percentage of E. coli was lower in the prebiotic group but again this did not reach statistical significance ( P=0.312 ) . CONCLUSION An infant formula containing prebiotic oligosaccharides is well tolerated , leads to normal somatic growth and suppresses the numbers of clostridia in the faeces with a trend for higher percentage of stool bifidobacteria and lower percentage of E. coli A double‐blind , r and omized , controlled study was performed in 90 full term infants to evaluate dose‐related bifidogenic effects of a new synergistic mixture of galacto‐oligosaccharides ( GOS ) and fructo‐oligosacharides ( FOS ) . The GOS/FOS mixture showed a dose‐dependent stimulatory effect on the intestinal growth of bifidobacteria . Also stool consistency and faecal pH were positively affected Objectives : The present study was design ed to evaluate the effect of 2 different combinations of prebiotic ingredients , polydextrose ( PDX ) , galactooligosaccharides ( GOS ) , and lactulose ( LOS ) , at 2 different intake levels on the overall growth and tolerance in healthy term infants up to 120 days of age . Patients and Methods : Healthy , formula-fed , term infants ( n = 226 ) were r and omly assigned to 1 of 3 study formula groups : control group ( n = 76 ) , PG4 group ( control formula supplemented with 4 g/L of a prebiotic blend , n = 74 ) , or PGL8 group ( control formula supplemented with 8 g/L of a prebiotic blend , n = 76 ) . Anthropometric measurements were taken at 14 , 30 , 60 , 90 , and 120 days of age , and 24-hour dietary recall and 24-hour tolerance recall were recorded at 30 , 60 , 90 , and 120 days of age . Adverse events were recorded throughout the study . Results : There were no statistically significant differences among the 3 formula groups for weight growth rate or length growth rate at any time point . Significant differences in stool consistency were detected among the 3 formula groups at 30 , 60 , and 90 days of age ( P < 0.001 , P = 0.025 , P = 0.004 , respectively ) , with the supplemented formula groups having looser stools than the control group . The PGL8 group had significantly higher stool frequency compared with the control and PG4 groups at 30 days of age ( P = 0.021 and P = 0.017 , respectively ) , but all of the groups were similar at 60 , 90 , and 120 days of age . A statistical difference was detected among the formula groups in 3 categories of adverse events : diarrhea ( control vs PG4 , 4 % vs 18 % , P = 0.008 ) , eczema ( PG4 vs control , 18 % vs 7 % , P = 0.046 ; PG4 vs PGL8 , 18 % vs 4 % , P = 0.008 ) , and irritability ( control vs PGL8 , 4 % vs 16 % , P = 0.027 ) . Conclusions : Infants fed formula supplemented with a prebiotic mixture achieved normal growth and stool characteristics more similar to those of breast-fed infants in comparison with infants fed an unsupplemented formula . A pediatrician needs to consider the risk of possible intolerance against the benefits of prebiotics Acute diarrhea is a common cause of infant morbidity and mortality . Probiotic supplemented infant formula is one of the effective methods for prevention of rotavirus diarrhea . Other benefits of the probiotics supplemented formula were evaluated by monitoring the growth of the children . A double-blind , placebo-controlled trial was done in 148 children aged 6 - 36 months . They were divided into 3 groups : the Bb12 group , 51 children received infant formula with Bifidobacteria Bb12 supplement ; the Bb12+ST  group , 54 children  received infant formula with Bb12 and Streptococcus thermophilus supplement ; and the control group , 43 children received infant formula without supplement . The mean weight Z-score according to WHO reference st and ard of the Bbl2 group was -1.8 + /- 0.12 , the Bb12+ST group was -1.4 + /- 0.11 and the control group was -1.8 + /- 0.13 at entry . The mean weight Z-score of children after 6 month showed that the children in the Bbl2+ST group had the highest increase in weight which was increased from -1.4 + /- 0.11 to -0.9 + /- 0.12 compared to the Z-score of the Bb12 group which had increased from -1.8 + /- 0.12 to -1.2 + /- 0.13 and in the control group from -1.8 + /- 0.13 to -1.7 + /- 0.25 . In terms of the mean height Z-score , the Bb12 group was -2.7 + /- 0.14 to -1.7 + /- 0.16 which was higher than the Bb12+ST group ( - 2.2 + /- 0.13 to -1.7 + /- 0.13 ) but was not different from the control group . However , the mean weight/height Z-score of the Bbl2+ST group had approached the reference st and ard ( Bb12 group -0.1 + /- 0.11 to -0.1 + /- 0.13 , Bb12+ST group -0.1 + /- 0.10 to 0.3 + /- 0.17 , control group -0.4 + /- 0.12 to -0.1 + /- 0.16 ) . Data showed that children who received the probiotics supplement formula had better growth during the 6 month period Background : Probiotic , prebiotic , and synbiotic ( a combination of pro- and prebiotic ) supplements increasingly are being used to prevent and treat a variety of health conditions . Although colonization is considered a key element in the success of such treatments , few clinical studies have addressed colonizing ability . Studies are even more limited in neonates and infants , who may benefit most from such treatment . The present study was conducted to determine the colonizing ability , tolerance , and impact on the stool flora of 7 days of administration of a synbiotic supplement to a neonatal cohort , in preparation for a larger hospital-based trial . Patients and Methods : In this r and omized , double-masked , controlled trial , healthy inborn newborns > 35 weeks of gestational age and > 1800 g birth weight were r and omized between 1 and 3 days after birth to receive an oral synbiotic preparation ( Lactobacillus plantarum and fructooligosaccharides ) or a dextrose saline placebo .  Two babies were treated with the synbiotic preparation for every 1 baby treated with the placebo . Duration of therapy was 7 days . Comprehensive stool cultures were done at baseline and on days 3 , 7 , 14 , 21 , and 28 . Results : Nineteen infants received the active study supplement and 12 infants received the placebo for 7 days . L plantarum was cultured from the stools of 84 % of the treated infants after 3 days of treatment , and from 95 % of infants on day 28 after birth . Of the infants , 100 % , 94 % , 88 % , 56 % , and 32 % remained colonized at months 2 , 3 , 4 , 5 , and 6 , respectively . In both groups , the total mean number of species and the mean log colony counts increased over time . The number of bacterial species was significantly higher on days 21 and 28 in the synbiotic preparation group compared with placebo ( P = 0.002 and 0.03 , respectively ) . There was a linear increase in the mean log gram-negative colony counts in the placebo group during the 4-week period that was significantly higher than that in the Lactobacillus group on days 14 , 21 , and 28 ( P < 0.001 for each ) . In contrast , the supplement group had significantly higher gram-positive colony counts on days 14 ( P = 0.002 ) and 28 ( P = 0.04 ) . Only 1 infant in the placebo group was colonized with L fermentum during the first 28 days of life . No difference was found in the percent increase in weight between baseline and day 7 , but on day 28 and months 2 , 3 , and 6 , the percent increase from baseline was higher in the probiotic-treated group ( P ≤ 0.05 ) . The supplement was tolerated well . Conclusions : The synbiotic preparation colonized quickly after 3 days of administration and the infants stayed colonized for several months after therapy was stopped . There was an increase in bacterial diversity and gram-positive organisms and a reduction of gram-negative bacterial load in the treatment group . Because a combination preparation was used , it is difficult to specifically attribute the colonization to either the probiotic or prebiotic component in this study . Larger efficacy trials are warranted to examine the mechanism of action and precise effects of these supplements Secretory immunoglobulin A ( SIgA ) plays an important role in the defence of the gastrointestinal tract . The level of faecal SIgA antibody is associated with increased neutralization and clearance of viruses . Formula-fed infants who lack the transfer of protective maternal SIgA from breast milk may benefit from strategies to support maturation of humoral immunity and endogenous production of SIgA. We aim ed at study ing the effects of st and ard , prebiotic and probiotic infant formulas on the faecal SIgA levels . At birth , infants of whom the mother had decided not to breastfeed were allocated to one of three formula groups in a r and omized , double-blind fashion . Nineteen infants received st and ard infant formula ; 19 received prebiotic formula containing a specific mixture of 0.6 g galacto-oligosaccharides (GOS)/fructo-oligosaccharides (FOS)/100 ml formula and 19 received probiotic formula containing 6.0 x 10(9 ) cfu Bifidobacterium animalis/100 ml formula . Faecal sample s were taken on postnatal day 5 , day 10 , wk 4 and every 4 wk thereafter until wk 32 . SIgA in faeces was determined by an enzyme-linked immunosorbent assay . During the intervention , infants fed on prebiotic formula showed a trend towards higher faecal SIgA levels compared with the st and ard formula-fed infants reaching statistical significance at the age of 16 wk . In contrast , infants fed on the probiotic formula showed a highly variable faecal SIgA concentration with no statistically significant differences compared with the st and ard formula group . Formula-fed infants may benefit from infant formulas containing a prebiotic mixture of GOS and FOS because of the observed clear tendency to increase faecal SIgA secretion . Adding viable B. animalis strain Bb-12 to infant formula did not reveal any sign for such a trend Objective : To test the safety and effect on faecal microbiota of a formula with prebiotic oligosaccharides alone or in combination with acidic oligosaccharides in infants at the age of partial formula feeding . Patients and Methods : The study was a double-blind , placebo-controlled , r and omised intervention trial in which 82 healthy , full-term , partially breast-fed children , from 1 week to 3 months old , were given 1 of the following formulae : whey-based formula ( control group ) , whey-based formula with galacto- and long-chain fructo-oligosaccharides ( scGOS/lcFOS group ) , or whey-based formula with galacto- and long-chain fructo-oligosaccharides added with pectin-derived acidic oligosaccharides ( scGOS/lcFOS/pAOS group ) . Children were studied for the duration of the partial formula feeding period and every 2 weeks for 2 months after breast-feeding cessation . The total bacteria count and the proportion of 7 bacterial families were determined using in situ hybridisation coupled to flow cytometry . Results : The total bacterial count did not alter with time or type of feeding ( 9.9 ± 0.1 log10 cells per gram wet weight ) . Compared with the control group , there was an increase of the Bifidobacterium genus ( P = 0.0001 ) , and a decrease of proportions for the Bacteroides group ( P = 0.02 ) and the Clostridium coccoides group ( P = 0.01 ) in both oligosaccharide groups . The proportion of bifidobacteria was significantly higher in the scGOS/lcFOS/pAOS compared with the scGOS/lcFOS group ( P < 0.01 ) . Conclusions : Infant formulae appear to be clinical ly safe and effective on infant microbiota . They minimize the alteration of faecal microbiota after cessation of breast-feeding and promote bifidobacteria proportions , with a stronger effect when acidic oligosaccharides are present OBJECTIVE . Live probiotic bacteria and dietary prebiotic oligosaccharides ( together termed synbiotics ) increasingly are being used in infancy , but evidence of long-term safety is lacking . In a r and omized , placebo-controlled , double-blind trial , we studied the safety and long-term effects of feeding synbiotics to newborn infants . METHODS . Between November 2000 and March 2003 , pregnant mothers carrying infants at high risk for allergy were r and omly assigned to receive a mixture of 4 probiotic species ( Lactobacillus rhamnosus GG and LC705 , Bifidobacterium breve Bb99 , and Propionibacterium freudenreichii ssp shermanii ) or a placebo for 4 weeks before delivery . Their infants received the same probiotics with 0.8 g of galactooligosaccharides , or a placebo , daily for 6 months after birth . Safety data were obtained from clinical examinations and interviews at follow-up visits at ages 3 , 6 , and 24 months and from question naires at ages 3 , 6 , 12 , and 24 months . Growth data were collected at each time point . RESULTS . Of the 1018 eligible infants , 925 completed the 2-year follow-up assessment . Infants in both groups grew normally . We observed no difference in neonatal morbidity , feeding-related behaviors ( such as infantile colic ) , or serious adverse events between the study groups . During the 6-month intervention , antibiotics were prescribed less often in the synbiotic group than in the placebo group ( 23 % vs 28 % ) . Throughout the follow-up period , respiratory infections occurred less frequently in the synbiotic group ( geometric mean : 3.7 vs 4.2 infections ) . CONCLUSION . Feeding synbiotics to newborn infants was safe and seemed to increase resistance to respiratory infections during the first 2 years of life Background / Aims : Supplementation with certain probiotics can improve gut microbial flora and immune function but should not have adverse effects . This study aim ed to assess the risk of D-lactate accumulation and subsequent metabolic acidosis in infants fed on formula containing Lactobacillus johnsonii ( La1 ® ) .  Methods : In the framework of a double-blind , r and omized controlled trial enrolling 71 infants aged 4–5 months , morning urine sample s were collected before and 4 weeks after being fed formulas with or without La1  ( 1 × 108/g powder ) or being breastfed . Urinary D- and L-lactate concentrations were assayed by enzymatic , fluorimetric methods and excretion was normalized per mol creatinine . Results : At baseline , no significant differences in urinary D-/L-lactate excretion among the formula-fed and breastfed groups were found . After 4 weeks , D-lactate excretion did not differ between the two formula groups , but was higher in both formula groups than in breastfed infants . In all infants receiving La1  , urinary D-lactate concentrations remained within the concentration ranges of age-matched healthy infants which had been determined in an earlier study using the same analytical method . Urinary L-lactate also did not vary over time or among groups . Conclusions : Supplementation of La1 to formula did not affect urinary lactate excretion and there is no evidence of an increased risk of lactic acidosis OBJECTIVE Cholesterol is a nutrient of essential importance in infant feeding because it is necessary in membrane development . In adults with high lipid levels , high doses of inulin ( oligofructose ) inconsistently decreased levels of serum cholesterol . The aim of the present study was to evaluate cholesterol and triacylglycerol levels in infants receiving a formula with a specific mixture of 0.6 g/100 mL of galacto-oligosaccharides ( GOS ) and long-chain fructo-oligosaccharides ( lcFOS ) in a ratio of 9/1 , a  control formula , or  breast milk .  Because the level of lcFOS in the infant milk is low , we hypothesized that there would be no differences between the formula groups . METHODS Two hundred fifteen infants were included in a prospect i ve , r and omized , double-blinded , placebo-controlled trial during the first 6 mo of life . Formula-fed infants were r and omized to receive a st and ard infant formula with a specific mixture of 0.6 g/100 mL of GOS/lcFOS , in a ratio of 9/1 , or a control formula .  Breast-fed infants were r and omized to receive one of these two formulas after the mother had decided to discontinue breastfeeding . Serum levels of cholesterol , high-density lipoprotein , low-density lipoprotein ( LDL ) , and triacylglycerol were determined at 8 and 26 wk of age and were provided for infants who received the GOS/lcFOS formula or control formula from birth or after cessation of breastfeeding and for the subgroups that were fully fed with breast milk and formula . RESULTS One hundred eighty-seven infants completed the study .  Total cholesterol and LDL levels at 8 and 26 wk were significantly lower in the formula-fed groups than in the breast-fed infants . There were no significant differences between the formula-fed groups . Levels of triacylglycerols and high-density lipoprotein did not differ between groups . CONCLUSION Our study demonstrated no differences in total cholesterol and LDL cholesterol in infants receiving an infant formula with GOS/lcFOS from infants receiving a control infant formula . Furthermore , total cholesterol and LDL cholesterol levels were higher in breast-fed infants than in formula-fed infants BACKGROUND The increase in allergic diseases is attributed to a relative lack of microbial stimulation of the infantile gut immune system . Probiotics , live health-promoting microbes , might offer such stimulation . OBJECTIVE We studied the effect of a mixture of 4 probiotic bacterial strains along with prebiotic galacto-oligosaccharides in preventing allergic diseases . METHODS We r and omized 1223 pregnant women carrying high-risk children to use a probiotic preparation or a placebo for 2 to 4 weeks before delivery . Their infants received the same probiotics plus galacto-oligosaccharides ( n = 461 ) or a placebo ( n = 464 ) for 6 months . At 2 years , we evaluated the cumulative incidence of allergic diseases ( food allergy , eczema , asthma , and allergic rhinitis ) and IgE sensitization ( positive skin prick test response or serum antigen-specific IgE level > 0.7 kU/L ) . Fecal bacteria were analyzed during treatment and at age 2 years . RESULTS Probiotic treatment compared with placebo showed no effect on the cumulative incidence of allergic diseases but tended to reduce IgE-associated ( atopic ) diseases ( odds ratio [ OR ] , 0.71 ; 95 % CI , 0.50 - 1.00 ; P = .052 ) . Probiotic treatment reduced eczema ( OR , 0.74 ; 95 % CI , 0.55 - 0.98 ; P = .035 ) and atopic eczema ( OR , 0.66 ; 95 % CI , 0.46 - 0.95 ; P = .025 ) . Lactobacilli and bifidobacteria more frequently ( P < .001 ) colonized the guts of supplemented infants . CONCLUSION Probiotic treatment showed no effect on the incidence of all allergic diseases by age 2 years but significantly prevented eczema and especially atopic eczema . The results suggest an inverse association between atopic diseases and colonization of the gut by probiotics . CLINICAL IMPLICATION S The prevention of atopic eczema in high-risk infants is possible by modulating the infant 's gut microbiota with probiotics and prebiotics
target: Synbiotics failed to significantly increase growth in boys and girls .
  Use of synbiotics increased stool frequency , had no impact on stool consistency , colic , spitting up / regurgitation , crying , restlessness or vomiting .
  Probiotics in formula also failed to have any significant effect on growth , stool frequency or consistency .
  Probiotics did not lower the incidence of diarrhoea , colic , spitting up / regurgitation , crying , restlessness or vomiting .
  Prebiotics in formula did increase weight gain but had no impact on length or head circumference gain .
  Prebiotics increased stool frequency but had no impact on stool consistency , the incidence of colic , spitting up / regurgitation , crying , restlessness or vomiting .
  There was no impact of prebiotics on the volume of formula tolerated , infections and gastrointestinal microflora .
  Authors ’ conclusions There is not enough evidence to state that supplementation of term infant formula with synbiotics , probiotics or prebiotics does result in improved growth or clinical outcomes in term infants .
  There is no data available to establish if synbiotics are superior to probiotics or prebiotics
background: Background Synbiotics , probiotics or prebiotics are being added to infant formula to promote growth and development in infants .
  Previous review s ( 2007 to 2011 ) on term infants given probiotics or prebiotics focused on prevention of allergic disease and food hypersensitivity .
  This review focused on growth and clinical outcomes in term infants fed only infant formula containing synbiotics , probiotics or prebiotics .