Probiotics to improve outcomes of colic in the community: Protocol for the Baby Biotics randomised controlled trial Treating infant colic with the probiotic Lactobacillus reuteri: double blind, placebo controlled randomised trial Synbiotic in the management of infantile colic: a randomised controlled trial. Probiotic Lactobacillus rhamnosus GG therapy and microbiological programming in infantile colic: a randomized, controlled trial Probiotics for infantile colic: a randomized, double-blind, placebo-controlled trial investigating Lactobacillus reuteri DSM 17938. Effectiveness of Lactobacillus reuteri in infantile colic and colicky induced maternal depression: a prospective single blind randomized trial Prophylactic use of a probiotic in the prevention of colic, regurgitation, and functional constipation: a randomized clinical trial. Lactobacillus reuteri DSM 17938 for the management of infantile colic in breastfed infants: a randomized, double-blind, placebo-controlled trial. 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 Lactobacillus reuteri (American Type Culture Collection Strain 55730) Versus Simethicone in the Treatment of Infantile Colic: A Prospective Randomized Study Prevention of Allergy in Infants of Allergic Mothers by Probiotic Escherichia coli Probiotic Intervention in the First Months of Life: Short-Term Effects on Gastrointestinal Symptoms and Long-Term Effects on Gut Microbiota Preventive effects of oral probiotic on infantile colic: a prospective, randomised, blinded, controlled trial using Lactobacillus reuteri DSM 17938. New strategies for the treatment of colic: modifying the parent/infant interaction. [Infants with colic. A heterogenous group possible to cure? Treatment by pediatric consultation followed by a study of the effect of zone therapy on incurable colic]. Infantile colic: crying time reduction with a whey hydrolysate: A double-blind, randomized, placebo-controlled trial.
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 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 AIM Infant colic is a frequent problem affecting up to 10 - 30 % of infants in first 3 months of life . Results from previous trials have shown that manipulation of gut microbiota can lead to symptomatic improvements . In a r and omised clinical trial , we aim ed to determine efficacy of synbiotic in reducing average infant crying time at day 7 and day 30 after starting intervention . METHODS Fifty breastfed infants aged 15 - 120 days with infantile colic r and omly assigned to receive either the synbiotic sachet containing 1 billion CFU of : Lactobacillus casei , L. rhamnosus , Streptococcus thermophilus , Bifidobacterium breve , L. acidophilus , B. infantis , L. bulgaricus and fructooligosacharide ( Protexin Healthcare , Somerset , UK ) , or placebo daily for 30 days . Parents were asked to record details of crying times in a symptoms diary . The primary outcome measure was the treatment success ( reduction in the daily crying time > 50 % ) and the secondary outcome measure was symptom resolution ( reduction in the daily crying time > 90 % ) . RESULTS The treatment success was significantly higher in synbiotic group ( 82.6 % ) compared with placebo ( 35.7 % ) at day 7 ( P < 0.005 ) . At day30 , treatment success was 87 % and 46 % in synbiotic and placebo group , respectively ( P < 0.01 ) . Symptom resolution was also higher in synbiotic group ( 39 % ) compared with placebo ( 7 % ) at day 7 ( P < 0.03 ) but not at day 30 ( 56 % vs.36 % , P = 0.24 ) . We encountered no complication related to synbiotic use . CONCLUSION This synbiotic ( a mixture of seven probiotic strains plus FOS ) significantly improved colic symptoms in comparison with placebo Background : Probiotic Lactobacillus reuteri and reduced allergen load may lessen the daily crying of colic infants , but the role of Lactobacillus rhamnosus GG ( LGG ) has remained obscure . Methods : Infants with colic ( n = 30 ) were enrolled during the first 6 wk of life . All families received behavioral support and allergen avoidance diet :  breastfeeding mothers followed cow ’s milk elimination diet and formula-fed infants received extensively hydrolyzed casein formula . The r and omized , double-blind intervention employed of LGG 4.5 × 109 cfu/d or placebo for a 4-wk study period . Daily crying was recorded by diaries and parental interviews . Fecal calprotectin and gut microbiota composition by quantitative PCR were evaluated before and after the intervention . Results : Daily crying time was comparable between the probiotic ( 173 min ) and the placebo group ( 174 min ; P = 0.99 ) at the end of the intervention according to the parental diary . However , parents reported a decrease of 68 % ( 95 % confidence interval ( CI ) : 58–78 ) in daily crying in the probiotic and 49 % ( 95 % CI : 32–66 ) in the placebo group ( P = 0.05 ) . Conclusion : LGG in infants treated in t and em with behavioral support and a cow ’s milk elimination diet did not provide additional treatment effect for diary-verified colic crying although parental report of crying suggested the probiotic intervention effective OBJECTIVE To investigate the effectiveness of Lactobacillus reuteri DSM 17938 for the treatment of infantile colic in breastfed Canadian infants , compared with placebo . STUDY DESIGN A r and omized , double-blind , placebo-controlled trial was conducted involving 52 infants with colic , according to modified Wessel criteria , who were assigned at r and om to receive L reuteri DSM 17938 ( 10(8 ) colony-forming units ) ( n = 24 ) or placebo ( n = 28 ) for 21 days . Daily crying and fussing times were recorded in a structured diary , and maternal question naires were completed to monitor changes in infant colic symptoms and adverse events . RESULTS Total average crying and fussing times throughout the study ( from baseline to day 21 ) were significantly shorter among infants with colic in the probiotic group compared with infants in the placebo group ( 1719 ± 750 minutes [ 29 ± 13 hours ] vs 2195 ± 764 minutes [ 37 ± 13 hours ] ; P = .028 ) ( relative risk , 0.78 ; 95 % CI , 0.58 - 0.98 ) . Infants given L reuteri DSM 17938 showed a significant reduction in daily crying and fussing times at the end of treatment period compared with those receiving placebo ( median , 60 minutes/day [ IQR , 64 minutes/day ] vs 102 minutes/day [ IQR , 87 minutes/day ] ; P = .045 ) . On day 21 , a significantly higher proportion of infants in the L reuteri DSM 17938 group responded to treatment with a ≥50 % crying time reduction compared with infants given placebo ( 17 vs 6 , P = .035 ; relative risk , 3.3 ; 95 % CI , 1.55 - 7.03 ) . CONCLUSION Administration of L reuteri DSM 17938 significantly improved colic symptoms by reducing crying and fussing times in breastfed Canadian infants with colic Infant colic , excessive crying of unknown cause , is a major burden to families and effects about 10–30 % of infants . Despite decades of research , the exact cause and treatment of infant colic has remained elusive . The use of Lactobacillus reuteri ( DSM 17938 ) in infant colic is somewhat controversial and hence , we design ed this study to evaluate its efficacy in infantile colic . We recruited predominantly or exclusively breastfed infants , aged less than 4 months in a placebo controlled observational r and omized study . Participants ’ were assigned to receive L. reuteri at a dose 108 colony forming units ( n = 21 ) and placebo ( n = 21 ) . Placebo was an identical formulation without live micro-organisms . Treatment was given to subjects for 21 days and they were followed for 4 weeks . Treatment success ( primary outcome ) , daily reduction in crying time , parent satisfaction and reduction in maternal depression ( secondary outcomes ) were assessed at the end of study period . Treatment success was observed in all infants ( 100 % ) of the probiotic group while it was seen in 15.7 % of the placebo group . Mean daily crying time was more significantly reduced to 32.1 ± 8.3 min/day ( P < 0.01 ) from 200.9 ± 6.3 min/day in the probiotic group as compared to the placebo group ( 120.6 ± 20.0 min/day ) . Moreover , throughout the study period , parent ’s satisfaction and improvement in maternal depression ( Edinburgh postnatal depression scale ) was also significantly higher in the probiotic group . In our study population , reduction in crying time was significant ( P < 0.01 ) even during first week of initiation of therapy . We conclude that L. reuteri ( DSM 17938 ) reduces daily crying time and maternal depression during infantile colic . We suggest L. reuteri may be a safe and efficacious option for reducing infant colic 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 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 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 . 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 Background : The objective is to study the effect of after-birth oral colonization by a probiotic Escherichia coli strain in infants of allergic mothers to reduce occurrence of allergy later in life . Methods : In a controlled clinical trial , 158 infants were r and omly divided into groups of ( i ) 56 colonized infants of allergic mothers , ( ii ) 57 control infants of allergic mothers , and ( iii ) 45 control infants of healthy mothers . Incidence rates of bacterial pathogens in stool and levels of anti-E. coli immunoglobulins and some cytokines in serum were determined , and secretory IgA was monitored in stool filtrates and maternal milk . Clinical check-ups of infants aged 4 days , 3 and 6 months , 2 , 3 and 5 years were carried out and clinical symptoms of allergy were monitored . One milliliter of the probiotic E. coli strain was administered to infants of allergic mothers at first within 48 h after birth and subsequently 3 times a week over a period of 4 weeks . Control infants of allergic and healthy mothers were monitored in these intervals as well . Results : Presence of the E. coli strain was monitored in stool sample s throughout the study . At the conclusion of the study , allergy symptoms were found in 14 infants of control allergic mothers , 7 infants of healthy mothers , and in 2 colonized infants of allergic mothers . Colonization affected levels of several cytokines and specific anti-E. coli antibodies . Conclusions : After birth , targeted colonization of the intestine by a probiotic E. coli strain can be an effective means of allergy prevention in infants of allergic mothers 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 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 INTRODUCTION The purpose of this study was to vali date the effectiveness of behavior modification in treating colicky infants . Colic was defined as a self-limiting condition in infants less than 4 months of age with a complex of physical behaviors and inconsolable crying ( > 2 hours a day for 3 days ) . It was hypothesized that when parents are given specific instructions about how to respond quickly and appropriately to their infant 's cues ( modification of the parent/infant interaction ) , the amount of crying by the infant decreases . METHOD A quasi-experimental design with an untreated control group and a pretest and posttest was used for the study . Twenty-three infants were r and omly assigned to intervention , nonintervention , and control groups . Crying diaries kept by the parents were used to obtain quantitative measurements of crying before and after intervention . The Nursing Child Assessment Feeding Scale ( NCAFS ) was used to measure parent/infant interaction . RESULTS Crying was significantly reduced from 3.79 hours per day to 1.12 hours per day ( F = 46.00 , df = 2 , P < .05 ) among infants whose parents received interventions of individualized counseling and education .  Caregivers of colicky infants in the intervention group scored lower on the NCAFS ( F = 5.59 , df = 2 , P < .05 ) . CONCLUSIONS Findings support previous research suggesting that crying can be reduced by modifying parental responses to the infant INTRODUCTION The aim of the study was to investigate and treat infants with colic by conventional medicine followed by an investigation of the effect of reflexological treatment . MATERIAL AND METHODS The investigation was prospect i ve , followed by a r and omised , single-blind , double-controlled , prospect i ve study of reflexological treatment with an interview and diary . Sixty-three infants aged 1 - 3 months referred by general practitioners with crying for > 90 minutes a day were given a paediatric examination and intervention . The cause of crying was discovered in 33 infants : Vitamin D ( 5 ) , elimination of cow 's milk protein ( 3 ) , and anal stenosis ( 3 ) ; counselling on feeding , sleep , reduction of stimulation , and avoidance of passive smoking ( 22 ) . Thirty infants without the benefit of paediatric consultation were r and omised to three groups for a duration of two weeks : A : Presumed non-effective reflexological treatment vs B : Presumed effective reflexological treatment vs C : No treatment -- only observation . The most important parameter was the number of crying hours over 24 hours . Cure was defined as crying for less than or equal to 30 minutes . RESULTS Examination by the paediatrician : Thirty-three of 63 infants benefited with a reduction in crying of less than 90 minutes and 13 of these infants were cured . The r and omised study : In group C ( control ) , none of the patients was cured . In groups A and B ( presumed non-effective reflexological treatment and presumed effective treatment ) , half the patients were cured , which was significantly better than in group C. There was no significant difference between groups A and B , but B seemed better than group A. B was significantly better than C. DISCUSSION Infantile colic had a significant cure rate at paediatric consultation and the children who did not benefit from this intervention had a significantly better outcome after reflexological treatment than had the observation group . Further investigations in reflexological treatment in infants are recommended 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
AND RELEVANCE Although L reuteri may be effective as treatment for crying in exclusively breastfed infants with colic , there is still insufficient evidence to support probiotic use to manage colic , especially in formula-fed infants , or to prevent infant crying .
IMPORTANCE  Excessive infant crying  is common , distressing , but without proven effective prevention or management options .
Probiotics may be a promising solution .
OBJECTIVE To examine whether probiotics are effective in the prevention/management of crying ( " colic " ) in infants 3 months or younger .