title: Effect of a Low-Allergen Maternal Diet on Colic Among Breastfed Infants: A Randomized, Controlled Trial Safety and acceptability of Lactobacillus reuteri DSM 17938 and Bifidobacterium longum subspecies infantis 35624 in Bangladeshi infants: a phase I randomized clinical trial Lactobacillus reuteri DSM 17938 for the management of infantile colic in breastfed infants: a randomized, double-blind, placebo-controlled trial. Administration of a Multi-Strain Probiotic Product to Women in the Perinatal Period Differentially Affects the Breast Milk Cytokine Profile and May Have Beneficial Effects on Neonatal Gastrointestinal Functional Symptoms. A Randomized Clinical Trial Probiotics to improve outcomes of colic in the community: Protocol for the Baby Biotics randomised controlled trial 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. Lactobacillus reuteri (American Type Culture Collection Strain 55730) Versus Simethicone in the Treatment of Infantile Colic: A Prospective Randomized Study Accuracy of data in abstracts of published research articles. Cow's Milk–Associated Gastrointestinal Symptoms Evaluated Using the Double-Blind, Placebo-Controlled Food Challenge Lactobacillus GG improves recovery in infants with blood in the stools and presumptive allergic colitis compared with extensively hydrolyzed formula alone. Growth and Tolerance of Term Infants Fed Formula With Probiotic Lactobacillus reuteri Prophylactic use of a probiotic in the prevention of colic, regurgitation, and functional constipation: a randomized clinical trial. Dietary treatment of infant colic: a double-blind study. The early administration of Lactobacillus reuteri DSM 17938 controls regurgitation episodes in full-term breastfed infants Improvement of symptoms in infant colic following reduction of lactose load with lactase. Safety and Tolerance of a Probiotic Formula in Early Infancy Comparing Two Probiotic Agents: A Pilot Study Effects of early prebiotic and probiotic supplementation on development of gut microbiota and fussing and crying in preterm infants: a randomized, double-blind, placebo-controlled trial. Reduction of crying episodes owing to infantile colic: a randomized controlled study on the efficacy of a new infant formula Treating infant colic with the probiotic Lactobacillus reuteri: double blind, placebo controlled randomised trial Effectiveness of casein hydrolysate feedings in infants with colic Fecal microflora in healthy infants born by different methods of delivery: permanent changes in intestinal flora after cesarean delivery. Infantile colic: crying time reduction with a whey hydrolysate: A double-blind, randomized, placebo-controlled trial. Cow's milk proteins cause infantile colic in breast-fed infants: a double-blind crossover study. Cow's milk whey protein elicits symptoms of infantile colic in colicky formula-fed infants: a double-blind crossover study. Preventive effects of oral probiotic on infantile colic: a prospective, randomised, blinded, controlled trial using Lactobacillus reuteri DSM 17938. Early neutral prebiotic oligosaccharide supplementation reduces the incidence of some allergic manifestations in the first 5 years of life. Long-Term Safety and Impact on Infection Rates of Postnatal Probiotic and Prebiotic (Synbiotic) Treatment: Randomized, Double-Blind, Placebo-Controlled Trial A low allergen diet is a significant intervention in infantile colic: results of a community-based study. Cow's milk formula as a cause of infantile colic: a double-blind study. Infant distress and development of functional gastrointestinal disorders in childhood: is there a connection? Infant colic: empirical evidence of the absence of an association with source of early infant nutrition. Probiotics and prebiotic galacto-oligosaccharides in the prevention of allergic diseases: a randomized, double-blind, placebo-controlled trial. The effects of probiotics on feeding tolerance, bowel habits, and gastrointestinal motility in preterm newborns. Lactobacillus reuteri DSM 17938 in Infantile Colic: A Randomized, Double-Blind, Placebo-Controlled Trial
abstract: Background . There is controversy regarding whether hypersensitivity to food proteins contributes to colic among breastfed infants . Methods . A r and omized , controlled trial of a low-allergen maternal diet was conducted among exclusively breastfed infants presenting with colic . In the active arm , mothers excluded cow 's milk , eggs , peanuts , tree nuts , wheat , soy , and fish from their diet ; mothers in the control group continued to consume these foods . Outcomes were assessed after 7 days , as the change in cry/fuss duration over 48 hours , with vali date d charts . The primary end point was a reduction in cry/fuss duration of ≥25 % from baseline . Mothers also assessed the responses to diet with categorical and visual analog scales . Results . Of 107 infants , 90 completed the trial ( mean age : 5.7 weeks ; range : 2.9–8.6 weeks ; 54 male infants ) . Infants in both groups presented with significant distress ( geometric mean : low-allergen group : 690 minutes per 48 hours ; control group : 631 minutes per 48 hours ) . In follow-up assessment s on days 8 and 9 , there were significantly more responders in the low-allergen group ( 74 % vs 37 % ) , ie , an absolute risk reduction of 37 % ( 95 % confidence interval : 18–56 % ) . Cry/fuss duration per 48 hours was reduced by a substantially greater amount in the low-allergen group ; the adjusted geometric mean ratio was 0.79 ( 95 % confidence interval : 0.63–0.97 ) , ie , an average reduction of 21 % ( 95 % confidence interval : 3–37 % ) . Mothers ' subjective assessment s of the responses to diet indicated little difference between the groups . Conclusion . Exclusion of allergenic foods from the maternal diet was associated with a reduction in distressed behavior among breastfed infants with colic presenting in the first 6 weeks of life Background Probiotics have rarely been studied in young healthy infants from low-income countries . This phase I study investigated the safety and acceptability of two probiotics in Bangladesh . Methods Healthy infants aged four to twelve weeks from urban slums in Bangladesh were r and omized to one of three different intervention dosing arms  ( daily , weekly , biweekly – once every two weeks ) of Lactobacillus reuteri DSM 17938 and Bifidobacterium longum subspecies infantis 35624 over one month or to a fourth arm that received no probiotics . All subjects were followed for two additional months . Reported gastrointestinal and respiratory symptoms as well as breastfeeding rates , hospitalizations , differential withdrawals , and caretakers ’ perception of probiotic use were compared among arms . Results In total , 160 infants were r and omized ( 40 to each arm ) with 137 ( Daily n = 35 , Weekly n = 35 , Biweekly n = 35 , Control n = 32 ) followed up for a median of twelve weeks ; 113 completed the study . Illness and breastfeeding rates were similar across all arms . Ten hospitalizations unrelated to probiotic use occurred . Forty eight percent of the caretakers of infants in intervention arms believed that probiotics improved their baby ’s health . Conclusions These two commonly used probiotics appeared safe and well-accepted by Bangladeshi families . Trial registration Clinical Trials.gov NCT01899378 . Registered July 10 , 2013 OBJECTIVE To determine whether administration of Lactobacillus reuteri ( L reuteri ) DSM 17938 is beneficial in breastfed infants with infantile colic . STUDY DESIGN Eighty infants aged < 5 months with infantile colic ( defined as crying episodes lasting 3 or more hours per day and occurring at least 3 days per week within 7 days prior to enrollment ) , who were exclusively or predominantly ( > 50 % ) breastfed were r and omly assigned to receive L reuteri DSM 17938 ( 10(8 ) colony-forming units ) ( n = 40 ) or an identically appearing and tasting placebo ( n = 40 ) , both orally , in 5 drops , 1 time daily , for 21 days . The primary outcome measures were the treatment success , defined as the percentage of children achieving a reduction in the daily average crying time ≥ 50 % , and the duration of crying ( minutes per day ) at 7 , 14 , 21 , and 28 days after r and omization . RESULTS The rate of responders to treatment was significantly higher in the probiotic group compared with the placebo group at day 7 ( P = .026 ) , at day 14 ( relative risk ( RR ) 4.3 , 95 % CI 2.3 - 8.7 ) , at day 21 ( RR 2.7 , 95 % CI 1.85 - 4.1 ) , and at day 28 ( RR 2.5 , 95 % CI 1.8 - 3.75 ) . In addition , throughout the study period , the median crying time was significantly reduced in the probiotic group compared with the control group . CONCLUSION Exclusively or predominantly breastfed infants with infantile colic benefit from the administration of L reuteri DSM 17938 compared with placebo Background : Probiotic supplementation to women during pregnancy and lactation can modulate breast milk composition , with immune benefits being transferred to their infants . Aim : The aim of the study was to evaluate the effect of high-dose probiotic supplementation to women during late pregnancy and lactation on cytokine profile and secretory IgA ( sIgA ) in breast milk and thus to study if differences in breast milk composition can affect lactoferrin and sIgA levels in stool sample s of newborns . The safety of maternal probiotic administration on neonatal growth pattern and gastrointestinal symptoms were also evaluated . Methods : In a double-blind , placebo-controlled , r and omized trial , 66 women took either the probiotic ( n = 33 ) or a placebo ( n = 33 ) daily . Levels of interleukins ( IL-6 , IL-10 and IL-1β ) , transforming growth factor-β1 ( TGF-β1 ) , and sIgA in breast milk ; and the level of sIgA and lactoferrin in newborn stool sample s were analyzed at birth and then again at one month of life . Antropometrical evaluation and analysis of gastrointestinal events in newborns was also performed . Results : Probiotic maternal consumption had a significant impact on IL6 mean values in colostrum and on IL10 and TGF-β1 mean values in mature breast milk . Fecal sIgA mean values were higher in newborns whose mothers took the probiotic product than in the control group . Probiotic maternal supplementation seems to decrease incidence of infantile colic and regurgitation in infants . Conclusion : High-dose multi-strain probiotic administration to women during pregnancy influences breast milk cytokines pattern and sIgA production in newborns , and seems to improve gastrointestinal functional symptoms in infants Background Infant colic , characterised by excessive crying/fussing for no apparent cause , affects up to 20 % of infants under three months of age and is a great burden to families , health professionals and the health system . One promising approach to improving its management is the use of oral probiotics . The Baby Biotics trial aims to determine whether the probiotic Lactobacillus reuteri DSM 17938 is effective in reducing crying in infants less than three months old ( < 13.0 weeks ) with infant colic when compared to placebo . Methods / Design Design : Double-blind , placebo-controlled r and omised trial in Melbourne , Australia . Participants : 160 breast and formula fed infants less than three months old who present either to clinical or community services and meet Wessel ’s criteria of crying and /or fussing . Intervention : Oral once-daily Lactobacillus reuteri ( 1x108 cfu ) versus placebo for one month . Primary outcome : Infant crying/fussing time per 24 hours at one month . Secondary outcomes : i ) number of episodes of infant crying/fussing per 24 hours and ii ) infant sleep duration per 24 hours ( at 7 , 14 , 21 , 28 days and 6 months ) ; iii ) maternal mental health scores , iv ) family functioning scores , v ) parent quality adjusted life years scores , and vi ) intervention cost-effectiveness ( at one and six months ) ; and vii ) infant faecal microbiota diversity , viii ) infant faecal calprotectin levels and ix ) Eschericia coli load ( at one month only ) . Analysis : Primary and secondary outcomes for the intervention versus control groups will be compared with t tests and non-parametric tests for continuous data and chi squared tests for dichotomous data . Regression models will be used to adjust for potential confounding factors . Intention-to-treat analysis will be applied . Discussion An effective , practical and acceptable intervention for infant colic would represent a major clinical advance . Because our trial includes breast and formula-fed babies , our results should generalise to most babies with colic . If cost-effective , the intervention ’s simplicity is such that it could be widely taken up as a new st and ard of care in the primary and secondary care sectors . Trial Registration Current Controlled Trials IS RCT 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 OBJECTIVE . The goal was to test the hypothesis that oral administration of Lactobacillus reuteri in a prospect i ve r and omized study would improve symptoms of infantile colic .  METHODS . Ninety breastfed colicky infants were assigned r and omly to receive either the probiotic L reuteri ( 108 live bacteria per day ) or simethicone ( 60 mg/day ) each day for 28 days . The mothers avoided cow 's milk in their diet . Parents monitored daily crying times and adverse effects by using a question naire . RESULTS . Eighty-three infants completed the trial : 41 in the probiotic group and 42 in the simethicone group . The infants were similar regarding gestational age , birth weight , gender , and crying time at baseline . Daily median crying times in the probiotic and simethicone groups were 159 minutes/day and 177 minutes/day , respectively , on the seventh day and 51 minutes/day and 145 minutes/day on the 28th day . On day 28 , 39 patients ( 95 % ) were responders in the probiotic group and 3 patients ( 7 % ) were responders in the simethicone group . No adverse effects were reported . CONCLUSIONS . In our cohort , L reuteri improved colicky symptoms in breastfed infants within 1 week of treatment , compared with simethicone , which suggests that probiotics may have a role in the treatment of infantile colic CONTEXT The section of a research article most likely to be read is the abstract , and therefore it is particularly important that the abstract reflect the article faithfully . OBJECTIVE To assess abstract s accompanying research articles published in 6 medical journals with respect to whether data in the abstract could be verified in the article itself . DESIGN Analysis of simple r and om sample s of 44 articles and their accompanying abstract s published during 1 year(July 1 , 1996-June 30 , 1997 ) in each of 5 major general medical journals ( Annals of Internal Medicine , BMJ , JAMA , Lancet , and New Engl and Journal of Medicine ) and a consecutive sample of 44 articles published during 15 months ( July 1 , 1996-August 15 , 1997 ) in the CMAJ . MAIN OUTCOME MEASURE Abstract s were considered deficient if they contained data that were either inconsistent with corresponding data in the article 's body ( including tables and figures ) or not found in the body at all . RESULTS The proportion of deficient abstract s varied widely ( 18%-68 % ) and to a statistically significant degree ( P<.001 ) among the 6 journals studied . CONCLUSIONS Data in the abstract that are inconsistent with or absent from the article 's body are common , even in large-circulation general medical journals Objective : The aim of this study was to evaluate the suspicion of cow's-milk allergy in infants with unspecific gastrointestinal ( GI ) symptoms using the double-blind , placebo-controlled food challenge . Methods : A prospect i ve cohort study , which recruited 57 consecutive children with gastrointestinally manifested symptoms suspected of cow's-milk allergy . All patients underwent a 5-day double-blind , placebo-controlled food challenge for cow 's milk . Results : The median age of the patients was 8.7 months . None had measurable cow's-milk – specific IgE. The food challenge was positive in 18 ( 32 % ) cases , with symptoms manifesting within 48 hours in 17 of 18 cases . The only symptom that correlated with the positive challenge was loose stools , reported as a presenting symptom in 78 % of challenge-positive and in 46 % of challenge-negative children ( P = 0.043 ) . During active challenge , the respective proportions were 82 % and 2 % ( P < 0.0001 ) . No serious adverse effects were manifested during the challenges . In the challenge-negative group , significant placebo reactions occurred in 18 ( 46 % ) patients . In the challenge-negative children , adult-type hypolactasia genotype CC frequency was higher ( 31 % , P = 0.033 ) than national prevalence of 18 % . Conclusions : In an infant with unspecific GI symptoms suspected of cow's-milk allergy , this diagnosis is seldom confirmed . Other reasons for the troublesome GI symptoms should also be identified OBJECTIVES To determine the benefits of Lactobacillus rhamnosus GG ( LGG ) in an extensively hydrolyzed casein formula ( EHCF ) in improving hematochezia and fecal calprotectin over EHCF alone . STUDY DESIGN Fecal calprotectin was compared in 30 infants with hematochezia and 4 weeks after milk elimination with that of a healthy group . We also compared fecal calprotectin and hematochezia on 26 formula-fed infants r and omly assigned to EHCF with LGG ( Nutramigen LGG ) ( EHCF + LGG ) or without ( Nutramigen ) ( EHCF - LGG )  and on 4 breastfed infants whose mothers eliminated dairy . RESULTS Fecal calprotectin in those with hematochezia was significantly higher than in comparisons ( mean + /- SD 325.89 + /- 152.31 vs 131.97 + /- 37.98 microg/g stool , t = 6.79 , P < .0001 ) . At 4 weeks , fecal calprotectin decreased to 50 % of baseline but was still significantly higher than in comparisons ( 157.5 + /- 149.13 vs 93.72 + /- 36.65 microg/g , P = .03 ) . Fecal calprotectin mean decrease was significantly larger among EHCF + LGG compared with EHCF - LGG ( -214.5 + /- 107.93 vs -112.7 + /- 105.27 microg/g , t = 2.43 , P = .02 ) . At 4 weeks , none of the EHCF + LGG had blood in stools , and 5/14 on EHCF - LGG did ( P = .002 ) . CONCLUSION Fecal calprotectin is elevated in infants with hematochezia and possible allergic colitis . EHCF + LGG result ed in significant improvement of hematochezia and fecal calprotectin compared with the EHCF alone Background . Lactobacillus reuteri has been studied for its safety and beneficial effects in infants . This study assessed growth of infants fed a partially hydrolyzed whey formula with L reuteri . Methods . Healthy term infants were r and omized to 1 of 2 formulas ( partially hydrolyzed whey formula with ( PRO ) or without ( CON ) L reuteri  from 14 to 112 days of age . Anthropometric measures were assessed at 14 , 28 , 56 , 84 , and 112 days of age . Tolerance records were completed 2 days prior to each visit . Results . A total of 122 subjects completed study per protocol ( 60 PRO , 62 CON ) . No differences were seen in daily weight gain , length , or head circumference . Overall , between groups , there were no significant differences in formula intake , stool frequency , color , consistency , flatulence , frequency of spit-up/vomiting , mood , sleep , or incidence of adverse events . Conclusion . Infants fed probiotic formula  had similar growth to infants fed control formula .  Both formulas were well tolerated IMPORTANCE Infantile colic , gastroesophageal reflux , and constipation are the most common functional gastrointestinal disorders that lead to referral to a pediatrician during the first 6 months of life and are often responsible for hospitalization , feeding changes , use of drugs , parental anxiety , and loss of parental working days with relevant social consequences . OBJECTIVE To investigate whether oral supplementation with Lactobacillus reuteri DSM 17938 during the first 3 months of life can reduce the onset of colic , gastroesophageal reflux , and constipation in term newborns and thereby reduce the socioeconomic impact of these conditions . DESIGN A prospect i ve , multicenter , double-masked , placebo-controlled r and omized clinical trial was performed on term newborns ( age < 1 week ) born at 9 different neonatal units in Italy between September 1 , 2010 , and October 30 , 2012 . SETTING Parents were asked to record in a structured diary the number of episodes of regurgitation , duration of inconsolable crying ( minutes per day ) , number of evacuations per day , number of visits to pediatricians , feeding changes , hospitalizations , visits to a pediatric emergency department for a perceived health emergency , pharmacologic interventions , and loss of parental working days . PARTICIPANTS In total , 589 infants were r and omly allocated to receive L reuteri DSM 17938 or placebo daily for 90 days . INTERVENTIONS Prophylactic use of probiotic . MAIN OUTCOMES AND MEASURES Reduction of daily crying time , regurgitation , and constipation during the first 3 months of life . Cost-benefit analysis of the probiotic supplementation . RESULTS At 3 months of age , the mean duration of crying time ( 38 vs 71 minutes ; P < .01 ) , the mean number of regurgitations per day ( 2.9 vs 4.6 ; P < .01 ) , and the mean number of evacuations per day ( 4.2 vs 3.6 ; P < .01 ) for the L reuteri DSM 17938 and placebo groups , respectively , were significantly different . The use of L reuteri DSM 17938 result ed in an estimated mean savings per patient of € 88 ( US $ 118.71 ) for the family and an additional € 104 ( US $ 140.30 ) for the community . CONCLUSIONS AND RELEVANCE Prophylactic use of L reuteri DSM 17938 during the first 3 months of life reduced the onset of functional gastrointestinal disorders and reduced private and public costs for the management of this condition . TRIAL REGISTRATION clinical trials.gov Identifier : NCT01235884 The possible role of cows milk intolerance in the aetiology of infant colic was evaluated in 19 babies presenting to their health visitor or general practitioner in one town . Over a three week period a st and ard modified cows milk formula was compared with a soya milk formula on a double blind basis . The duration of colic symptoms was significantly reduced during the week on soya milk ( P less than 0.01 ) , with 11 out of 19 babies fulfilling the diagnostic criteria for cows milk intolerance . Four babies whose symptoms failed to improve either spontaneously or with soya milk were given a hydrolysed protein milk with a positive response in two , confirmed by challenge testing . Thus in 13 out of 19 babies ( 68 % ) the symptoms of infant colic resolved almost completely with dietary change Abstract Forty breastfed full-term infants were r and omly , double blind assigned to receive orally Lactobacillus reuteri ( L. reuteri ) DSM 17938 , 5 drops/daily ( 108 colony-forming units ) , for 4 weeks ( n = 20 ) or an identical placebo ( n = 20 ) , starting before third day of life . They underwent basal and final visit to monitor growth parameters and gastrointestinal ( GI ) disease . Parents registered daily : crying minutes , stool frequency and consistency , numbers of regurgitations , adverse events . Secretory IgA ( sIgA ) has been measured in saliva on 28th day . Treated infants demonstrated a reduction in daily regurgitations at the end of treatment ( p = 0.02 ) , three neonates in the placebo group only needed simethicone for GI pain , sIgA level was similar in both groups . R and om casualty produced an unbalanced gender distribution in the groups , but this bias did not affect the results . Therefore , early administration of L. reuteri DSM 17938 result ed beneficial in preventing regurgitation episodes during the first month of life Transient lactose intolerance has been identified as a possible causative factor in infant colic . A double-blind r and omised placebo-controlled crossover study to investigate this has been undertaken in 53 babies with symptoms of colic . Pre-incubation of the feed with lactase result ed in breath hydrogen levels and total crying time which were both at least 45 % lower than figures with placebo treatment , in 26 % of the full trial group ( 95 % confidence interval 12.9 % to 44.4 % ) , and in 38 % of compliers ( 95 % confidence interval 18.8 % to 59.4 % ) . The remainder did not respond to the same extent . These findings suggest that infant colic may have a multiple aetiology , and that in a significant number of cases the immediate cause is transient lactose intolerance , in which cases pretreatment of feeds with lactase can result in considerable symptomatic benefits 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 OBJECTIVE To evaluate the impact of early prebiotic and probiotic intervention on  preterm infants ' well-being , crying , growth , and microbiological programming . STUDY DESIGN Ninety-four preterm infants ( gestational age 32 - 36 weeks and birth weight > 1500 g ) r and omized to receive prebiotics ( mixture of galacto-oligosaccharide and polydextrose 1:1 ) , probiotics ( Lactobacillus rhamnosus GG ) , or placebo during the first 2 months of life were followed up for 1 year . Infants were categorized based on the extent of crying and irritability during the first 2 months of life , and their gut microbiota was investigated by fluorescence in situ hybridization ( n = 66 ) and quantitative polymerase chain reaction ( n = 63 ) . RESULTS A total of 27 of 94 infants ( 29 % ) infants were classified as excessive criers , significantly less frequently in the prebiotic and the probiotic groups than in the placebo group ( 19 % vs 19 % vs 47 % , respectively ; P = .02 ) . The placebo group had a higher percentage of Clostridium histolyticum group bacteria in their stools than did the probiotic group ( 13.9 % vs 8.9 % , respectively ; P = .05 ) . There were no adverse events related to either supplementation . CONCLUSIONS Early prebiotic and probiotic supplementation may alleviate symptoms associated with crying and fussing in preterm infants . This original finding may offer new therapeutic and preventive measures for this common disturbance in early life Objectives : The aim of this study was to evaluate the efficacy on crying episodes owing to infantile colic of a new infant formula containing partially hydrolysed whey proteins , prebiotic oligosaccharides ( OS ) , with a high β-palmitic acid content . Design : Prospect i ve r and omized controlled study . Setting : Italy . Subjects : Two hundred and sixty-seven formula-fed infants , aged less than 4 months , with infantile colic , were r and omized to receive either the new infant formula ( study treatment ( ST ) ) or a st and ard formula and simethicone ( 6 mg/kg twice a day ) ( control treatment ( CT ) ) . A question naire was given to parents to evaluate for 14 days the daily number of colic episodes and crying time . Results : Out of the 199 infants who completed the study , 96 were treated with the new formula and 103 were not treated . Infants receiving the new formula had a significant decrease in colic episodes after 1 week ( 2.47±1.94 at day 7 vs 5.99±1.84 at the study entry ) compared to infants receiving the CT ( 3.72±1.98 at day 7 vs 5.41±1.88 at the study entry ) ( P<0.0001 ) . Also at day 14 , the crying episodes were significantly different between the two groups of infants ( 1.76±1.60 in ST vs 3.32±2.06 in CT ) ( P<0.0001 ) . Conclusions : The use of a partially hydrolysed formula supplemented with fructo- and galacto-OS induces a reduction of crying episodes in infants with colic after 7 and 14 days when compared with a st and ard formula and simethicone . Sponsorship : The study was supported by funds from Numico , Italy Objective To determine whether the probiotic Lactobacillus reuteri DSM 17938 reduces crying or fussing in a broad community based sample of breastfed infants and formula fed infants with colic aged less than 3 months . Design Double blind , placebo controlled r and omised trial . Setting Community based sample ( primary and secondary level care centres ) in Melbourne , Australia . Participants 167 breastfed infants or formula fed infants aged less than 3 months meeting Wessel ’s criteria for crying or fussing : 85 were r and omised to receive probiotic and 82 to receive placebo .  Interventions Oral daily L reuteri ( 1 × 108 colony forming units ) versus placebo for one month . Main outcomes measures The primary outcome was daily duration of cry or fuss at 1 month . Secondary outcomes were duration of cry or fuss ; number of cry or fuss episodes ; sleep duration of infant at 7 , 14 , and 21 days , and 1 and 6 months ; maternal mental health ( Edinburgh postnatal depression subscale ) ; family functioning ( paediatric quality of life inventory ) , parent quality adjusted life years ( assessment of quality of life ) at 1 and 6 months ; infant functioning ( paediatric quality of life inventory ) at 6 months ; infant faecal microbiota ( microbial diversity , colonisation with Escherichia coli ) , and calprotectin levels at 1 month . In intention to treat analyses the two groups were compared using regression models adjusted for potential confounders . Results Of 167 infants r and omised from August 2011 to August 2012 , 127 ( 76 % ) were retained to primary outcome ; of these , a subset was analysed for faecal microbial diversity , E coli colonisation , and calprotectin levels . Adherence was high . Mean daily cry or fuss time fell steadily in both groups . At 1 month , the probiotic group cried or fussed 49 minutes more than the placebo group ( 95 % confidence interval 8 to 90 minutes , P=0.02 ) ; this mainly reflected more fussing , especially for formula fed infants . The groups were similar on all secondary outcomes . No study related adverse events occurred . Conclusions L reuteri DSM 17938 did not benefit a community sample of breastfed infants and formula fed infants with colic . These findings differ from previous smaller trials of selected population s and do not support a general recommendation for the use of probiotics to treat colic in infants . Trial registration Current Controlled Trials IS RCT N95287767 This study found that two casein hydrolysate formulas varying in composition were equally effective in managing  colicky symptoms associated with protein sensitivity . Both hydrolysate formulas were associated with a significant , comparable reduction in crying duration and intensity from baseline in 15 of 22 infants with complete data . Subsequent challenge data suggest that the population studied were infants experiencing colicky symptoms due to protein sensitivity . A greater proportion of infants showed a positive reaction ( ≥1.5h of crying/d ) to the protein challenges than the placebo challenge , and crying was rated as more intense during whey and milk protein challenges BACKGROUND Newborn infants in modern maternity hospitals are subject to numerous factors that affect normal intestinal colonization -- for example , cesarean delivery and antimicrobial agents . To study the duration of the effect of external factors on intestinal colonization , two groups of infants with different delivery methods were investigated . METHODS The fecal flora of 64 healthy infants was studied prospect ively . Thirty-four infants were delivered vaginally , and 30 by cesarean birth with antibiotic prophylaxis administered to their mothers before the delivery . The fecal flora was cultured on nonselective and selective media in infants 3 to 5 , 10 , 30 , 60 , and 180 days of age . Gastrointestinal signs were recorded daily by the mothers for 2 months . RESULTS The fecal colonization of infants born by cesarean delivery was delayed . Bifidobacterium-like bacteria and Lactobacillus-like bacteria colonization rates reached the rates of vaginally delivered infants at 1 month and 10 days , respectively . Infants born by cesarean delivery were significantly less often colonized with bacteria of the Bacteroides fragilis group than were vaginally delivered infants : At 6 months the rates were 36 % and 76 % , respectively ( p=0.009 ) . The occurrence of gastrointestinal signs did not differ between the study groups . CONCLUSIONS This study shows for the first time that the primary gut flora in infants born by cesarean delivery  may be disturbed for up to 6 months after the birth . The clinical relevance of these changes is unknown , and even longer follow-up is needed to establish how long-lasting these alterations of the primary gut flora can be OBJECTIVE To determine the effectiveness of whey hydrolysate formula in the treatment of infantile colic in a primary care setting in the Netherl and s. STUDY DESIGN R and omized , double-blind , parallel trial with a 1-week qualification period and a 1-week intervention period . Participants . Forty-three healthy , thriving , formula-fed infants , < 6 months old , crying > 3 hours per day on at least 3 days per week . Infants were r and omized to whey hydrolysate formula ( n = 23 ) or st and ard formula ( n = 20 ) . MAIN OUTCOME MEASURE Difference in duration of crying ( minutes per day ) between qualification week and intervention week . RESULTS Analysis according to the intention to treat principle showed a difference in the decrease of crying duration of 63 minutes per day [ 95 % confidence interval : 1 - 127 minutes per day ] in favor of the whey hydrolysate formula .  Five infants did not complete the trial . The scope of the study was not sufficient to expect significant differences in the subgroup analyses . CONCLUSIONS An extensively hydrolyzed whey formula is effective in reducing the duration of crying in a primary care setting Sixty-six mothers of 66 breast-fed infants with infantile colic were put on a diet free from cow 's milk . The colic disappeared in 35 infants ; it reappeared on at least two challenges ( cow 's milk to mother ) in 23 infants ( 35 % ) . A double-blind crossover trial with cow 's milk whey protein was performed in 16 of these 23 mothers and infants . Six infants had to be taken out of the study for various reasons ; of the remaining ten infants , nine reacted with colic after their mothers ' intake of whey protein-containing capsules . Sequential analysis showed a high correlation between infantile colic in breast-fed infants and their mothers ' consumption of cow 's milk protein . A diet free of cow 's milk is suggested for the mothers as a first trial of treatment of infantile colic in breast-fed infants There are several causes of infantile colic . The aim of this study was to evaluate , under controlled conditions , whether bovine whey proteins can elicit symptoms of infantile colic in colicky formula-fed infants . The mean age for entering the study was 6.4 weeks and the mean age for colic debut was 3.7 weeks . In 24 of 27 infants with severe colic , the symptoms disappeared when they were given a cow 's milk-free diet ( Nutramigen ) .  These 24 infants were entered into a double-blind crossover study . The infants ( receiving cow 's milk-free diet ) were given the contents of identical capsules with each meal during day 6 . The same procedure was repeated on day 10 . The capsules contained either whey protein powder ( with Nutramigen added ) or human albumin powder ( with Nutramigen added ) . Eighteen infants receiving the whey protein-containing capsules reacted with colic , two infants receiving placebo reacted with colic ( P less than .001 ) , and four infants did not react at all . Crying hours per day for the 24 infants were 5.6 hours for formula-fed infants and 0.7 hour for cow 's milk-free diet-fed infants ( P less than .001 ) . Crying hours per day were 3.2 hours for the infants receiving whey protein capsules and 1.0 hour for those receiving placebo ( P less than .001 ) . In conclusion , bovine whey protein can elicit symptoms of infantile colic in colicky formula-fed infants Infants were recruited in four centres in North-West Italy . 138 infants were assessed for eligibility , 113 ones underwent r and omisation and 105 completed the study . Newborns aged less than 10 days of life , with gestational age between 37 and 42 weeks , birth weight from 2,500 to 4,300 g and normal physical examination were recruitable . Premature infants and infants affected by outcomes of perinatal hypoxia or necrotising enterocolitis have been excluded . Patients were r and omly assigned to receive five drops containing Lactobacillus reuteri DSM 17938 ( 108 cfu ) with 400 UI of vitamin D3 or only 400 UI of vitamin D3 daily . The primary endpoints concern the administration of pain relieving agents ( cimetropium bromide at least three times per week or simethicone at least five times per week ) from baseline to 12 weeks . Additional analyses were done on the percentage of infants that switched from an exclusive breastfeeding to a partial or exclusive formula feeding from baseline to 12 weeks . Data concerning the number of calls to the paediatricians and the number of visits at paediatricians ' ambulatories due to infantile colic have been collected by paediatrician and analysed . Comparing the two groups , the relative risk was 0.04 ( 95 % confidence interval (CI)=0.01 - 0.31 ) for cimetropium bromide , 0.24 ( 95 % CI=0.14 - 0.41 ) for simethicone and 0.37 ( 95 % CI=0.17 - 0.80 ) for the administration of infant formula , showing a protective action of L. reuteri . The treatment group showed a lower number of paediatric consultations related to episodes of infant colic than the control group ( P<0.0001 ) . L. reuteri DSM 17938 supplementation at the tested dosage could reduce parental discomfort due to infantile colic . The consumption of this probiotic is associated with a reduction of paediatric consultations for infantile colic , as well as use of pain relieving agents and of infant formula BACKGROUND A mixture of neutral prebiotic oligosaccharides has been shown to reduce the incidence of atopic dermatitis ( AD ) and allergy associated symptoms during the first 2 years of life . OBJECTIVE To evaluate if this protective effect against allergy lasted beyond the intervention period until 5 y of age . METHODS In a prospect i ve , double blind , placebo-controlled fashion , healthy term infants at risk of atopy were fed either a prebiotic-supplemented ( 0.8 g/100 ml scGOS/lcFOS ) or placebo-supplemented ( 0.8 g/100 ml maltodextrin ) hypoallergenic formula during the first 6 mo of life . Following this intervention period , follow-up continued until 5 y of life . The present study evaluated ( i ) the cumulative incidence of allergic manifestations during 5 y , and ( ii ) the prevalence of allergic and persistent allergic manifestations at 5 y. Monitored allergic manifestations were AD , recurrent wheezing , allergic rhinoconjunctivitis and urticaria . RESULTS Ninety-two children ( 50 in placebo group , 42 in intervention group ) completed the 5-y follow-up . The 5-y cumulative incidences of any allergic manifestation and atopic dermatitis were significantly lower in the scGOS/lcFOS group ( 30.9 , 19.1 % , respectively ) compared to placebo group ( 66 , 38 % , respectively ) ( p < 0.01 and < 0.05 ) . Children in the scGOS/lcFOS group tended to have a lower incidence of allergic rhinoconjunctivitis , and allergic urticaria ( 4.8 vs 16 % for both manifestations , p=0.08 ) . There was no difference in the cumulative incidence of recurrent wheezing . With regard to the prevalences at 5 y , intervention group had significantly lower prevalence of any persistent allergic manifestation and rhinoconjunctivitis ( 4.8 , 2.4 % , respectively ) compared to placebo ( 26 , 14 % , respectively ) ( p < 0.01 and = 0.05 ) . Prevalence of persistent AD tended to be lower in the intervention group ( 2.4 vs 12 % , p= 0.09 ) . Although intervention group had 75 % reduction in the prevalence of persistent wheezing ( 4.8 vs 14 % ) , no significance was shown . CONCLUSION Oligosaccharide prebiotics ( scGOS/lcFOS ) , when started early in life have a protective effect against allergic manifestations in high risk infants . The protection lasts beyond infancy until 5 y of life , for AD and allergic rhinoconjunctivitis . Long-term follow-up studies in larger population s are warranted to evaluate the potential preventive effect of this mixture on asthma 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 The effect of diet change in 38 bottle-fed and 77 breast-fed " colicky " infants , referred from community-based pediatric facilities was studied over a 1-week period in a double-blind ( within each feeding mode ) , r and omized , placebo-controlled trial . METHODS Bottle-fed infants were assigned to either casein hydrolysate or cow 's milk formula .  All mothers of breast-fed infants were started on an artificial color-free , preservative-free , additive-free diet and also r and omized to an active low allergen diet ( milk- , egg- , wheat- , nut-free ) or a control diet . RESULTS The response to diet was assessed on day 1 and day 8 with the use of a previously vali date d infant distress chart on which parents recorded distress levels . If successful outcome was defined as a reduction in distress of 25 % or more , after adjusting for age and feeding mode , infants on active diet had a significantly higher rate of improvement than those on the control diet ( odds ratio , 2.32 ; 95 % confidence interval , 1.07 - 5.0 ; p = 0.03 ) . Analysis of the day 8 to day 1 distress ratio , again adjusted for age and feeding mode , showed that infants on the active diet had distress reduced by 39 % ( 95 % confidence interval , 26 - 50 ) compared with 16 % ( 95 % confidence interval , 0 - 30 ) for those on the control diet ( p = 0.012 ) . CONCLUSION The results suggest a period of dietary modification with a low allergen diet and appropriate nutritional support should be considered in healthy infants with colic The role of cow 's milk in infantile colic in formula-fed infants was estimated in a double-blind study . Sixty colicky infants were given a cow 's milk-containing formula ( Enfamil ) and a cow 's milk-free formula based on soy ( ProSobee ) . Eleven infants ( 18 % ) were free of symptoms while receiving soy formula .  Symptoms of 32 infants ( 53 % ) were unchanged or worse when they were fed cow 's milk formula and soy formula , but symptoms disappeared when they were fed a formula containing hydrolyzed casein ( Nutramigen ) . Symptoms of 17 infants ( 29 % ) could not be related to the diet ; these infants were permitted to continue on a cow 's milk-based formula . A challenge with cow 's milk-based formula after one month ( at approximately age 3 months ) produced symptoms of infantile colic in 22 infants ( 36 % ) . At age 6 months , a challenge with cow 's milk was positive in 11 infants ( 18 % ) with epidermal and gastrointestinal symptoms . Eight infants ( 13 % ) at 12 months of age and five infants ( 8 % ) at 16 months of age were still intolerant to cow 's milk . Cow 's milk seems to be a major cause of infantile colic  in formula-fed infants . A dietary treatment is suggested for moderate or severe forms of the colic . Cow 's milk protein intolerance is common later in infancy in these infants Infant Distress and Development of Functional Gastrointestinal Disorders in Childhood : Is There a Connection ? One infant in 4 manifests with abundant crying , fussing , or colic cry  and is brought for medical evaluation during the first months of life.1 Concomitantly , excessive antigen uptake and bacterial translocation ensue across the immature gut barrier.2 Not surprisingly , infant crying has been related to food allergy3 and aberrant gut microbiota composition4 and these have , in turn , been linked to functional gastrointestinal disorders (FGIDs).5 We hypothesized that colic crying is associated with FGIDs later in childhood BACKGROUND The etiology of infant colic  remains unknown , despite an abundance of research on the topic . OBJECTIVE To determine whether breastfeeding has a protective effect in colic 's development . DESIGN A prospect i ve cohort study of 856 mother-infant dyads . Eligible participants included English-speaking adult residents of a region in Ontario , who gave birth , at term , to a live singleton whose birth weight was appropriate for gestational age .  Self-administered question naires , mailed to mothers at 1 and 6 weeks post partum , requested information on several infant and maternal factors , including source of infant nutrition ( exclusively breastfed , complementary fed , and exclusively formula fed ) . Cases of colic were identified by applying modified Wessel criteria to data recorded in the Barr Baby Day Diary or by interpreting responses to the Ames Cry Score . MAIN OUTCOME MEASURES Prevalence of colic among breastfed , formula-fed , and complementary-fed infants ; and adjusted odds ratios ( AORs ) reflecting the prevalence of colic among formula- and complementary-fed infants relative to those who were breastfed . RESULTS Of 856 mothers , 733 ( 86 % ) completed the first question naire and 617 ( 72 % ) completed the second question naire . Overall , the prevalence of colic at 6 weeks was 24 % . No association was seen between the source of infant nutrition and colic 's development . In multivariate analyses , higher levels of maternal trait anxiety ( AOR , 1.22 ; 95 % confidence interval [ CI ] , 0.96 - 1.54 ) , maternal alcohol consumption at 6 weeks ( AOR , 1.57 ; 95 % CI , 1.03 - 2.40 ) , and shift work during pregnancy ( AOR , 1.27 ; 95 % CI , 0.73 - 2.21 ) were associated with an increased likelihood of colic , after controlling for feeding method , maternal age , and parity . In these same analyses , being married or having a common-law partner ( AOR , 0.30 ; 95 % CI , 0.10 - 0.87 ) and being employed full-time during pregnancy ( AOR , 0.60 ; 95 % CI , 0.32 - 1.14 ) were associated with a reduced likelihood of colic . CONCLUSIONS Breastfeeding did not have a protective effect on the development of colic . Although colic was statistically associated with several variables , including preexisting maternal anxiety , much of colic 's etiology remains unexplained 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 OBJECTIVE To investigate the effect of dietary supplementation with a probiotic on feeding tolerance and gastrointestinal motility in healthy formula-fed preterm infants . STUDY DESIGN Thirty preterm newborns were enrolled ; 10 were exclusively breast-fed , and the remaining 20 were r and omly assigned in a double-blind manner to receive either Lactobacillus reuteri ATCC 55730 ( at dose of 1 x 10(8 ) colony forming units a day ) or placebo for 30 days . Clinical symptoms of gastrointestinal function ( regurgitation , vomiting , inconsolable crying , and evacuation ) and physiological variables ( gastric electrical activity and emptying ) were recorded before and after the dietary intervention . RESULTS Body weight gains per day were similar for the 3 groups , and no adverse events were recorded . Newborns receiving probiotics showed a significant decrease in regurgitation and mean daily crying time and a larger number of stools compared with those given placebo .  Gastric emptying rate was significantly increased , and fasting antral area was significantly reduced in both the newborns receiving L. reuteri and breast-fed newborns compared with placebo . CONCLUSIONS Our results suggest a useful role for L. reuteri supplementation in improving feeding tolerance and gut function in formula-fed preterm newborns OBJECTIVE : To test the efficacy of Lactobacillus reuteri on infantile colic and to evaluate its relationship to the gut microbiota . STUDY DESIGN : Fifty exclusively breastfed colicky infants , diagnosed according to modified Wessel 's criteria , were r and omly assigned to receive either L reuteri DSM 17 938 ( 108 colony-forming units ) or placebo daily for 21 days . Parental question naires monitored daily crying time and adverse effects . Stool sample s were collected for microbiologic analysis . RESULTS : Forty-six infants ( L reuteri group : 25 ; placebo group : 21 ) completed the trial . Daily crying times in minutes/day ( median [ interquartile range ] ) were 370 ( 120 ) vs 300 ( 150 ) ( P = .127 ) on day 0 and 35.0 ( 85 ) vs 90.0 ( 148 ) ( P = .022 ) on day 21 , in the L reuteri and placebo groups , respectively . Responders ( 50 % reduction in crying time from baseline ) were significantly higher in the L reuteri group versus placebo group on days 7 ( 20 vs 8 ; P = .006 ) , 14 ( 24 vs 13 ; P = .007 ) , and 21 ( 24 vs 15 ; P = .036 ) . During the study , there was a significant increase in fecal lactobacilli ( P = .002 ) and a reduction in fecal Escherichia coli and ammonia in the L reuteri group only ( P = .001 ) . There were no differences in weight gain , stooling frequency , or incidence of constipation or regurgitation between groups , and no adverse events related to the supplementation were observed . CONCLUSION : L. reuteri DSM 17 938 at a dose of 108 colony-forming units per day in early breastfed infants improved symptoms of infantile colic and was well tolerated and safe . Gut microbiota changes induced by the probiotic could be involved in the observed clinical improvement
target: AUTHORS ' CONCLUSIONS There is no clear evidence that probiotics are more effective than placebo at preventing infantile colic ; however , daily crying time appeared to reduce with probiotic use compared to placebo .
  There were no clear differences in adverse effects .
background: BACKGROUND Infantile colic is typically defined as full-force crying for at least three hours per day , on at least three days per week , for at least three weeks .
  Infantile colic affects a large number of infants and their families worldwide .
  Its symptoms are broad and general , and while not indicative of disease , may represent a serious underlying condition in a small percentage of infants who may need a medical assessment .
  Probiotics are live microorganisms that alter the microflora of the host and provide beneficial health effects .
  The most common probiotics used are of Lactobacillus , Bifidobacterium and Streptococcus .
  There is growing evidence to suggest that intestinal flora in colicky infants differ from those in healthy infants , and it is suggested that probiotics can redress this balance and provide a healthier intestinal microbiota l and scape .
  The low cost and easy availability of probiotics makes them a potential prophylactic solution to reduce the incidence and prevalence of infantile colic .
  OBJECTIVES To evaluate the efficacy and safety of prophylactic probiotics in preventing or reducing severity of infantile colic .