title: Effect of a Low-Allergen Maternal Diet on Colic Among Breastfed Infants: A Randomized, Controlled Trial Evaluation of the effect of a fiber-enriched formula on infant colic. Effectiveness of massage, sucrose solution, herbal tea or hydrolysed formula in the treatment of infantile colic. Efficacy of herbal tea preparation in infantile colic. Dietary treatment of infant colic: a double-blind study. Colic and the effect of changing formulas: a double-blind, multiple-crossover study. Dietary modifications versus dicyclomine hydrochloride in the treatment of severe infantile colics Reduction of crying episodes owing to infantile colic: a randomized controlled study on the efficacy of a new infant formula Effectiveness of casein hydrolysate feedings in infants with colic Infantile colic: crying time reduction with a whey hydrolysate: A double-blind, randomized, placebo-controlled trial. Parental counseling compared with elimination of cow's milk or soy milk protein for the treatment of infant colic syndrome: a randomized trial. Cow's milk whey protein elicits symptoms of infantile colic in colicky formula-fed infants: a double-blind crossover study. Mothers' perceptions of problems of feeding and crying behaviors. A prospective study. MATERNAL DIET AND INFANTILE COLIC IN BREAST-FED INFANTS Association between infantile colic and carbohydrate malabsorption from fruit juices in infancy. Infantile colic and feeding. Consequences of incomplete carbohydrate absorption from fruit juice consumption in infants. Clinical Response to 2 Commonly Used Switch Formulas Occurs within 1 Day 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.
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 Because infants with colic appear to have  abdominal pain  similar to that of adults with irritable bowel syndrome , who may benefit from the addition of fiber to their diet , we tested whether fiber added to infant formula would alleviate colic .  Twenty-seven normal , term infants ( aged 2 to 8 weeks ; 14 girls ) with colic , defined as crying plus fussing for more than 3 hours a day for at least 3 days of a 6-day baseline period , were enrolled . Infants were r and omly assigned in 9-day periods to a sequence of placebo ( Isomil formula ) followed by fiber-supplemented formula ( Isomil plus soy polysaccharide ) ( n = 12 ) or the reverse ( n = 15 ) . Daily diaries of crying , fussing , sleeping , formula , intake , and stooling were kept . Twenty-two infants completed three lactulose breath hydrogen tests at the end of the baseline period and after each study period . The crossover trial was followed by 30 to 35 days of use of the study formula chosen by the parents as most beneficial but unknown to the investigators . Growth was monitored throughout . Serum cholesterol , calcium , phosphate , albumin , iron , and zinc concentrations were measured at the conclusion . There were no significant differences in average daily time spent by the infants in fussing and crying during ingestion of the fiber-supplemented formula . However , parents of 18 of 27 infants chose fiber-supplemented formula as most beneficial in ameliorating symptoms of colic . While the infants were consuming fiber-supplemented formula , stool frequency increased , and breath hydrogen excretion increased significantly , in response to lactulose . Growth and serum biochemical measurements were normal in all infants . Supplementation of infant formula with the level of soy polysaccharide used in this study may have reduced crying and fussing in some infants but did not affect colicky behavior in the majority of infants , who continued to cry and fuss excessively AIM AND OBJECTIVE The aim of the study was to evaluate the effectiveness of massage , sucrose solution , herbal tea or hydrolysed formula , each used individually in the treatment of infantile colic . BACKGROUND The term colic describes a group of symptoms that occur frequently in infants , consisting of paroxysmal abdominal pain and severe crying . Infant colic is of importance for both parents and the community health services that provide families with care , and is therefore an important clinical problem that is amenable to nursing interventions . DESIGN This prospect i ve and r and omised-controlled study involved 175 infants in Turkey . METHODS Data were gathered by using Wessel criteria ; parents wrote a daily structured diary , recording the onset and duration of crying . Patients were assigned r and omly into four different intervention groups ( massage , sucrose solution , herbal tea and hydrolysed formula ) and control group .  Duration of crying following each intervention was recorded in the diary by parents for a one week period . RESULTS There was a significant reduction in crying hours per day in all intervention groups . The difference between mean duration of total crying ( hours/day ) before and after the intervention infants in hydrolysed formula group was found higher than massage , sucrose and herbal tea group . The difference between mean duration of total crying(hours/day ) before and after the intervention infants in massage group was found lower than other intervention groups and all groups . CONCLUSION Our findings demonstrated that varied interventions such as administration of massage , sucrose solution , herbal tea and hydrolysed formula are effective in the treatment of colic . The difference between mean duration of total crying ( hours/day ) before and after the intervention in hydrolysed formula group was found higher than other intervention groups . Hydrolysed formula was the most effective in reducing the duration of crying ( hours/day ) when compared with the other intervention groups . Massage intervention yielded the least symptomatic improvement among all the interventions . RELEVANCE TO CLINICAL PRACTICE Colic treatment models used in this study can be used by nurses in neonatal and primary healthcare setting s as an aid to families for the treatment of infantile colic We evaluated the effect of an herbal tea preparation on  infantile colic  in a prospect i ve double-blind study . The use of tea eliminated the colic in 19 ( 57 % ) of 33 infants , whereas placebo was helpful in only 9 ( 26 % ) of 35 ( p < 0.01 ) . The mean colic score was significantly improved in tea-treated infants . No significant differences were noted between groups regarding number of night wakings 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 This study investigated the effect of changing the formulas of colicky infants and addressed the method ologic flaws of earlier studies . Attention was paid to issues of design ing a blind study , providing a washout period , and measuring and reproducing the effect . In this r and omized , double-blind trial , three changes of formula were made : for each of four 4-day periods , colicky infants alternately received a casein hydrolysate formula ( Nutramigen ) and a formula containing cow milk . Mothers recorded crying in diaries and indicated which crying episodes they considered to have been caused by colic . Nine infants were started on Nutramigen and eight on the cow milk formula .  With the first formula change there was significantly less crying and colic in infants when they were fed Nutramigen than when they were fed cow milk ( p less than 0.01 ) ; with the second change there was less colic when infants were fed Nutramigen ( p less than 0.05 ) but not significantly less crying . By the third change there were no significant differences between formulas . Further analyses demonstrated that there were more clinical ly meaningful positive responses ( a change in crying by at least one third ) to Nutramigen than to cow milk ( p less than 0.05 ) . However , only one subject had a clinical ly meaningful response in colic to all three formula changes . These results demonstrate that in some instances , colic improves with elimination of cow milk formula . However , the effect diminishes with time , and only infrequently is the effect reproducible This study examined 120 infants , aged 3–12 weeks , with severe colics and compared the results of a specific hypoallergenic diet ( group A ) with those of pharmacological treatment ( group B ) . Non‐breastfed group A infants  received soy milk and if unresponsive , hydrolyzed milk formulas ;  mothers of breast‐fed infants  received a diet without cow 's milk , eggs or fish .  Breast‐fed and non‐breast‐fed group B infants received dicyclomine hydrochloride 3 mg/kg/day . Results , based on quantitative measurements of crying . indicated that in breast‐fed infants there was no significant improvement between group A ( 62.5 % ) and group B ( 66.6 % ) infants . Among formula‐fed infants , comparison of positive results using soy milk ( 65.9 % ) with positive results using dicyclomine ( 53.3 % ) was not significant ; positive results using soy milk and hydrolyzed milk formulas in non‐responders to soy milk , provided an improvement in 95.4 % of cases . Pharmacological treatment provided an improvement in 53.3 % ) of cases . The diffcrence was significant ( p<0.01 ) 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 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 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 Treating the infant colic syndrome by counseling the  parents  concerning more effective responses to the infant crying is compared to the elimination of soy or cow 's milk protein from the infant 's diet in a r and omized clinical trial . Because symptoms of vomiting and diarrhea are not part of the infant colic syndrome , infants with these gastrointestinal symptoms were excluded from the study .  Dietary changes were accomplished by either feeding the infants a hydrolyzed casein formula or by requiring mothers to eliminate milk from their diets . In phase 1 of the study , the group receiving counseling  ( n = 10 ) had a decrease in crying from 3.21 + /- 1.10 h/d to 1.08 + /- 0.70 h/d ( P = .001 ) . The crying in the group that received dietary changes ( n = 10 ) decreased from 3.19 + /- 0.69 h/d to 2.03 + /- 1.07 h/d ( P = .01 ) , a level still greater than twice normal . The decrease in those receiving counseling was faster and greater than that of those given dietary changes ( P less than .02 ) . In the second phase of the study , group 2 infants were reexposed to cow 's milk or soy protein and the parents received counseling . In this phase , counseling again decreased crying significantly from 2.09 + /- 1.07 h/d to 1.19 + /- 0.60 h/d ( P = .05 ) . No infant in the study who improved with changes in his or her diet had a significant increase in crying , with reexposure to soy or cow 's milk protein . ( ABSTRACT TRUNCATED AT 250 WORDS 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 During early infancy , problems of crying , colic , spitting , and feeding difficulties often provoke anxiety and lack of self-confidence in parents . We studied prospect ively what proportion of mothers felt that their infants had problems of this type and determined risk factors for perceived problems identified in the early postnatal period . The mothers of 189 breast-fed and 184 formula-fed infants completed question naires post partum and responded to a follow-up interview at four months . Thirty-five percent of mothers in each group reported that their infants had moderate or severe problems of feeding or crying behavior . Risk factors for perceived problems were identified using stepwise logistic regression analyses . Inquiry about , and early attention to , risk factors may alleviate the parents ' concerns and possibly affect the development of these problems This paper reports the results of placebo-controlled double-blind r and omized cross-over trial design ed to examine the effects of elimination of cow 's milk from maternal diet on rates of infantile colic . Subjects were 20 exclusively breast-fed infants , aged 3 - 18 weeks , with persistent colic . Each mother was given 600 ml drink to be drunk every day ; on 6 of the days the drink contained 300 ml of cow 's milk and 300 ml of soya milk ; on the remaining days it contained 600 ml of soya milk ; the 2 drinks were formulated to be undistinguishable ; the trial days were grouped into blocks of 2 days , r and omly assigned . Mothers were also instructed to record time and duration of any colic , and to record their own daily diet . Avoidance of cow 's milk produced no beneficial effects on the incidence of colic in the babies ; but when frequency of colic was related to days on which specific foods were eaten by the mothers the rates of colic were found to be significantly higher on days on which mothers reported eating chocolate or fruit . These results do not support the contention that elimination of cow 's milk from maternal diet may influence the likelihood of infantile colics ; the source of colic , however , can not be attributed to a single dietary component , but it may involve a combination of foodstuffs OBJECTIVE To determine whether infantile colic ( IC ) is associated with malabsorption of carbohydrates present in fruit juices . METHODS In this double-blind study , parents of 30 healthy infants ( 5.1 + /- 0.7 months , 7.4 + /- 1.0 kg , 64 + /- 4 cm ) were administered a question naire to quantitatively assess IC . Thereafter , they were divided into 2 groups , 16 infants with and 14 without IC . Within each treatment group infants were fed 120 mL ( 16.3 + /- 2.0 mL/kg ) of either white grape ( sorbitol-free ; 1:1 fructose-to-glucose ratio ) or apple ( sorbitol 0.5 g/dL ; 2.6:1 fructose-to-glucose ratio ) juice .  Physical activity ( PA ) , energy expenditure ( EE ) , crying , and sleeping times were measured for 0.5 and 3.0 hours before and after juice feeding , respectively , using the Enhanced Metabolic Testing Activity Chamber . Carbohydrate malabsorption was determined by breath hydrogen ( BH(2 ) ) gas analysis after juice feedings . Statistical differences between groups were determined by 2-way analysis of variance with the Tukey procedure . RESULTS Infants with IC fed apple juice exhibited carbohydrate malabsorption as shown by increased BH(2 ) excretion , whereas those without IC absorbed carbohydrates normally when fed this juice . Infants fed apple juice with carbohydrate malabsorption cried more and consequently slept less during the last 1.5 hours of the study . This was associated with increased PA and EE as compared with infants without IC fed apple juice . In contrast , infants fed white grape juice , regardless of IC , showed no increase in BH(2 ) excretion , PA , and EE . Furthermore , crying and sleeping times were unchanged in infants fed white grape juice regardless of the presence or absence of IC . CONCLUSIONS IC was associated with carbohydrate malabsorption from fruit juices containing sorbitol and a high fructose-to-glucose ratio In a double blind crossover study 10 children with infantile colic were fed breast milk and cow 's milk formula , untreated and treated with lactase .  Colic was present on 71 % of breast milk and 89 % of cow 's milk days . Daily duration and severity of colic did not differ for milk preparations BACKGROUND Most infants consume fruit juices by 6 months of age . However , fruit juices containing sorbitol may be associated with carbohydrate malabsorption without clinical symptoms . We hypothesized that increased physical activity and metabolic rate may be associated with carbohydrate malabsorption . METHODS Physical activity and metabolic rate were determined in 14 healthy infants ( [ mean + /- SD ] age , 5.1 + /- 0.8 months ; weight , 7.8 + /- 1.1 kg ; length , 67 + /- 4.2 cm ; and body fat , 26 % + /- 5 % ) for 3 hours in a respiratory chamber . Seven were fed pear juice , and the other 7 were fed white grape juice ( 120 mL ) after a 2-hour fast . Pear juice contains sorbitol and a high fructose-glucose ratio , whereas white grape juice is sorbitol free and has a low fructose-glucose ratio . Carbohydrate absorption was determined by breath hydrogen gas analysis . The study was double-blinded . RESULTS When compared with the infants without carbohydrate malabsorption ( peak breath hydrogen level < 20 ppm above baseline ) , 5 of the 7 infants fed pear juice and 2 of the 7 infants fed white grape juice exhibited carbohydrate malabsorption ( peak breath hydrogen level > or = 20 ppm above baseline ; P < .01 ) . These infants also exhibited both increased physical activity ( P < .001 ) and metabolic rate ( P < .05 ) after juice consumption in comparison with infants with normal carbohydrate absorption . When grouped according to the type of juice consumed , only infants fed pear juice exhibited increases in physical activity ( P < .01 ) . CONCLUSIONS Carbohydrate malabsorption is associated with increased physical activity and metabolic rate in infants . Most of the infants who had carbohydrate malabsorption consumed pear juice . Therefore , fruit juices containing sorbitol and high levels of fructose may not be optimal for young infants Very fussy or extremely fussy infants were r and omized to receive :  soy-based formula ( Soy : n = 82 ) or a partially hydrolyzed cow 's milk protein ( CMP ) , low-lactose formula ( PHF : n = 77 ) in a multicenter , double-blind , r and omized , parallel , prospect i ve 28-day feeding trial . Body weight and infant formula tolerance were reported . Adverse events were recorded throughout the study . A significant reduction in mean scores of fussiness , gas , spit-up , and crying compared with baseline measures was observed in infants who received either Soy or PHF within 1 day of formula intake ; improvement in symptoms was sustained by study end . Stool consistency remained constant through day 28 in the PHF group , whereas stools in the Soy group became more firm by day 2 and did not return to pre study consistency . PHF , with a protein profile patterned more closely on human breast milk , improved symptoms of formula intolerance as well as soy-based formula 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
target: In breastfed infants , evidence suggests that a hypoallergenic maternal diet may be beneficial for reducing symptoms of colic .
  In formula-fed infants , colic may improve after changing from a st and ard cow ’s milk formula to either a hydrolysed protein formula or a soy-based formula .
  Fibre-supplemented formulae had no effect .
background: Infantile colic , the cause of 10–20 % of all early paediatrician visits , can lead to parental exhaustion and stress .
  A systematic review was conducted to examine whether dietary change provides an effective therapy for  infantile colic .