Lactobacillus reuteri (American Type Culture Collection Strain 55730) Versus Simethicone in the Treatment of Infantile Colic: A Prospective Randomized Study Effectiveness of Lactobacillus reuteri in infantile colic and colicky induced maternal depression: a prospective single blind randomized trial Lactobacillus reuteri DSM 17938 for the management of infantile colic in breastfed infants: a randomized, double-blind, placebo-controlled trial. Probiotic Lactobacillus rhamnosus GG therapy and microbiological programming in infantile colic: a randomized, controlled trial Preventive effects of oral probiotic on infantile colic: a prospective, randomised, blinded, controlled trial using Lactobacillus reuteri DSM 17938. Synbiotic in the management of infantile colic: a randomised controlled trial. Lactobacillus reuteri DSM 17938 in Infantile Colic: A Randomized, Double-Blind, Placebo-Controlled Trial Probiotics for infantile colic: a randomized, double-blind, placebo-controlled trial investigating Lactobacillus reuteri DSM 17938. Prophylactic use of a probiotic in the prevention of colic, regurgitation, and functional constipation: a randomized clinical trial. Cow's milk whey protein elicits symptoms of infantile colic in colicky formula-fed infants: a double-blind crossover study. The effect of fennel (Foeniculum Vulgare) seed oil emulsion in infantile colic: a randomized, placebo-controlled study. Effectiveness of massage, sucrose solution, herbal tea or hydrolysed formula in the treatment of infantile colic. 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 Effectiveness of Mentha piperita in the Treatment of Infantile Colic: A Crossover Study Randomised controlled trial of infantile colic treated with chiropractic spinal manipulation Effect of minimal acupuncture for infantile colic: a multicentre, three-armed, single-blind, randomised controlled trial (ACU-COL) Cimetropium Bromide in the Treatment of Crisis in Infantile Colic Long-Term Safety and Impact on Infection Rates of Postnatal Probiotic and Prebiotic (Synbiotic) Treatment: Randomized, Double-Blind, Placebo-Controlled Trial Infant massage compared with crib vibrator in the treatment of colicky infants. Protective effect of probiotics in the treatment of infantile eczema. Mothers’ postpartum psychological adjustment and infantile colic Cow's milk formula as a cause of infantile colic: a double-blind study. The short-term effect of spinal manipulation in the treatment of infantile colic: a randomized controlled clinical trial with a blinded observer. 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 A prospective 10-year study on children who had severe infantile colic. Long-term consumption of infant formulas containing live probiotic bacteria: tolerance and safety. Cow's milk proteins cause infantile colic in breast-fed infants: a double-blind crossover study. Treatment of infantile colic with dicyclomine hydrochloride. Infantile colic: crying time reduction with a whey hydrolysate: A double-blind, randomized, placebo-controlled trial. Oral supplementation with probiotics in very-low-birth-weight preterm infants: a randomized, double-blind, placebo-controlled trial. Infantile colic: child and family three years later. Reduction of crying episodes owing to infantile colic: a randomized controlled study on the efficacy of a new infant formula Treatment of Infantile Colic with Surface Active Substance (Simethicone)
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 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 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 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 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 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 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 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 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 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 CONTEXT Despite its benign , natural course , colic is a significant problem in infants and imparts a psychological , emotional , and physical burden to parents . Dicyclomine hydrochloride is the only pharmacological treatment for infantile colic that has been consistently effective . Unfortunately , 5 % of infants treated with dicyclomine hydrochloride develop serious side effects , including death .  Fennel seed oil has been shown to reduce intestinal spasms and increase motility of the small intestine . However , there have not been any clinical studies of its effectiveness . OBJECTIVES To determine the effectiveness of fennel seed oil emulsion in infantile colic . DESIGN R and omized placebo-controlled trial . SETTING S Two large multi-specialty clinics . SUBJECTS 125 infants , 2 to 12 weeks of age , who met definition of colic . INTERVENTION Fennel seed oil emulsion compared with placebo . OUTCOME MEASURE Relief of colic symptoms , which was defined as decrease of cumulative crying to less than 9 hours per week . RESULTS The use of fennel oil emulsion eliminated colic , according to the Wessel criteria , in 65 % ( 40/62 ) of infants in the treatment group , which was significantly better than 23.7 % ( 14/59 ) of infants in the control group ( P < 0.01 ) . There was a significant improvement of colic in the treatment group compared with the control group [ Absolute Risk Reduction ( ARR ) = 41 % ( 95 % CI 25 to 57 ) , Number Needed to Treat ( NNT ) = 2 ( 95 % CI 2 to 4 ) ] . Side effects were not reported for infants in either group during the trial . CONCLUSION Our study suggests that fennel seed oil emulsion is superior to placebo in decreasing intensity of infantile colic 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 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 Background . Infantile colic is a distressing and common condition for which there is no proven st and ard treatment . Objective . To compare the efficacy of Mentha piperita with simethicone in treatment for infantile colic . Methods . A double-blind crossover study was performed with 30 infants attending IMIP , Recife , Brazil . They were r and omized to use Mentha piperita or simethicone in the treatment of infantile colic during 7 days with each drug . Primary outcomes were mother_s opinion about responses to the treatment , number of daily episodes of colic , and time spent crying , measured by a chronometer . Mann-Whitney and chi-square tests were used to compare the results . This study was previously approved by the Ethical Committee in Research at IMIP . Results . At baseline daily episodes of infantile colic was 3.9 ( ±1.1 ) and the mean crying time per day was 192 minutes ( ±51.6 ) . At the end of the study daily episodes of colic fell to 1.6 ( ±0.6 ) and the crying duration decreased to 111 ( ±28 ) minutes . All mothers reported decrease of frequency and duration of the episodes of infantile colic and there were no differences between responses to Mentha piperita and simethicone . Conclusions . These findings suggest that Mentha piperita may be used to help control infantile colic . However , these results must be repeated by others studies AIMS To investigate the efficacy of chiropractic spinal manipulation in the management of infantile colic . METHODS One hundred infants with typical colicky pain were recruited to a r and omised , blinded , placebo controlled clinical trial . RESULTS Nine infants were excluded because inclusion criteria were not met , and five dropped out , leaving 86 who completed the study . There was no significant effect of chiropractic spinal manipulation . Thirty two of 46 infants in the treatment group ( 69.9 % ) , and 24 of 40 in the control group ( 60.0 % ) , showed some degree of improvement . CONCLUSION Chiropractic spinal manipulation is no more effective than placebo in the treatment of infantile colic . This study emphasises the need for placebo controlled and blinded studies when investigating alternative methods to treat unpredictable conditions such as infantile colic Background Evidence for treating infantile colic with acupuncture is contradictory . Aim To evaluate and compare the effect of two types of acupuncture versus no acupuncture in infants with colic in public child health centres ( CHCs ) . Methods A multicentre , r and omised controlled , single-blind , three-armed trial ( ACU-COL ) comparing two styles of acupuncture with no acupuncture , as an adjunct to st and ard care , was conducted . Among 426 infants whose parents sought help for colic and registered their child 's fussing/crying in a diary , 157 fulfilled the criteria for colic and 147 started the intervention . All infants received usual care plus four extra visits to CHCs with advice/support ( twice a week for 2 weeks ) , comprising gold st and ard care . The infants were r and omly allocated to three groups : ( A ) st and ardised minimal acupuncture at LI4 ; ( B ) semi-st and ardised individual acupuncture inspired by Traditional Chinese Medicine ; and ( C ) no acupuncture . The CHC nurses and parents were blinded . Acupuncture was given by nurses with extensive experience of acupuncture . Results The effect of the two types of acupuncture was similar and both were superior to gold st and ard care alone . Relative to baseline , there was a greater relative reduction in time spent crying and colicky crying by the second intervention week ( p=0.050 ) and follow-up period ( p=0.031 ) , respectively , in infants receiving either type of acupuncture . More infants receiving acupuncture  cried <3 hours/day , and thereby no longer fulfilled criteria for colic , in the first ( p=0.040 ) and second ( p=0.006 ) intervention weeks . No serious adverse events were reported . Conclusions Acupuncture appears to reduce crying in infants with colic safely . Trial registration number NCT01761331 ; Results Background Treatment of infantile colic remains an open issue . In Italy , cimetropium bromide is used extensively to treat infantile colic . The aim of this r and omized , double-blind , placebo-controlled clinical trial was to investigate the effectiveness and side effects of cimetropium bromide in the treatment of infants with colic crisis . Methods Ninety-seven infants with colic were enrolled . The diagnosis of infantile colic in healthy infants with regular growth , aged 15 to 60 days was made according to the criteria of Wessel . The infants were divided into two groups , one treated with cimetropium bromide ( 1.2 mg/kg ) and the other treated with placebo at onset of each crisis for 3 days . Duration of crying and side effects were recorded daily in a structured diary for the 3 days of therapy . Statistical analysis was performed using the chi-square and t tests . Results Eighty-six infants completed the trial .  The average duration of crying for each crisis was 17.3 ± 12.6 minutes in the cimetropium bromide group and 47.5 ± 28.5 minutes in the placebo group ( P < 0.005 ) . Response to cimetropium bromide was 74 % . Response to placebo was 33 % ( P < 0.05 ) . Side effects did not differ significantly between the two groups , except sleepiness , which increased in the infants treated with cimetropium bromide . Conclusion Cimetropium bromide was more effective than placebo in reducing the duration of crying in children with infantile colic . The use of the anticholinergic drugs , aside from the dicyclomine because of its dangerous side effects , should be revaluated for treating infantile colic 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 OBJECTIVE To evaluate the effectiveness of infant massage compared with that of a crib vibrator in the treatment of infantile colic . METHODS Infants < 7 weeks of age and perceived as colicky by their parents were r and omly assigned to an infant massage group ( n = 28 ) or a crib vibrator group ( n = 30 ) . Three daily intervention periods were recommended in both groups . Parents recorded infant crying and given interventions in a structured cry diary that was kept for 1 week before ( baseline ) and for 3 weeks during the intervention . Parents were interviewed after the first and third weeks of intervention to obtain their evaluation of the effectiveness of the given massage or crib vibration . RESULTS At baseline , the mean amount of total crying was 3.6 ( st and ard deviation : 1.4 ) hours/day in the massage group infants and 4.2 ( 2.0 ) hours/day in the vibrator group infants . The mean amount of colicky crying was 2.1 ( st and ard deviation : 1.1 ) hours/day and 2.9 ( 1.5 ) hours/day , respectively . The mean number of daily intervention periods was 2.2 in both groups . Over the 4-week study , the amount of total and colicky crying decreased significantly in both intervention groups . The reduction in crying was similar in the study groups : total crying decreased by a mean 48 % in the massage group and by 47 % in the vibrator group , and colicky crying decreased by 64 % and 52 % , respectively . The amount of other crying ( total crying minus colicky crying ) remained stable in both groups over the intervention . Ninety-three percent of the parents in both groups reported that colic symptoms decreased over the 3-week intervention , and 61 % of the parents in the massage group and 63 % of the parents in the crib vibrator group perceived the 3-week intervention as colic reducing . CONCLUSIONS Infant massage was comparable to the use of a crib vibrator in reducing crying in colicky infants . We suggest that the decrease of total and colicky crying in the present study reflects more the natural course of early infant crying and colic than a specific effect of the interventions The aim of the present study was to provide evidence for the application of probiotics in the prevention and treatment of infantile eczema by exploring changes in the intestinal Bifidobacteria levels and the Scoring Atopic Dermatitis ( SCORAD ) index prior and subsequent to treatment with probiotics in infants with eczema . A total of 40 infants with eczema were r and omly divided into treatment and control groups . Prior and subsequent to the treatment , the SCORAD index was evaluated and the content of Bifidobacterium bifidum in the stool of each infant in the two groups was quantified using 16S rRNA/DNA quantitative polymerase chain reaction analysis . After four weeks of treatment with B. bifidum triple viable capsules , the levels of B. bifidum increased sharply ( P<0.05 ) and the SCORAD index was notably reduced ( P<0.05 ) as compared with the values prior to treatment . By contrast , neither the content of B. bifidum nor the SCORAD index changed significantly in the control group after four weeks ( P>0.05 ) . Following treatment , the levels of B. bifidum in the stools of the treatment group were significantly higher than those in the stools of the control group ( P<0.05 ) , and the SCORAD index was significantly lower than that of the control group ( P<0.05 ) . In conclusion , probiotic supplementation has a positive effect on the prevention and treatment of infantile eczema Background : Infantile colic is a common problem of early infancy . There is limited data on the relation between postpartum maternal psychological problems and colic . Aim : : To investigate whether infantile colic is associated with postpartum mood disorders or insecure adult attachment style of the mother . Methods : Seventy eight mothers and newborns were enrolled in this prospect i ve , longitudinal study . Maternal depressive symptoms were screened with Edinburgh Postpartum Depression Score ( EPDS ) and maternal anxiety was assessed with State-Trait Anxiety Inventory ( STAI ) . The  Adult Attachment Scale  was used to determine the attachment style of the mother . Infantile colic was defined according to Wessel criteria . Results : Infantile colic was present in 17 infants ( 21.7 % ) ; 12.9 % of the mothers had an EPDS ⩾13 . The mean EPDS of the mothers whose infants had infantile colic ( 10.2±6.0 ) was significantly higher than that of the mothers of infants without colic ( 6.3±4.0 ) . Among infants with infantile colic , 62.5 % had mothers who had insecure attachment style , whereas only 31.1 % of mothers had insecure attachment when the infant did not have infantile colic . Conclusion : Postpartum maternal depressive symptoms and insecure attachment style are associated with infantile colic . Screening and early intervention of postpartum depression might promote the health of both the mother and infant 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 OBJECTIVE To determine whether there is a short-term effect of spinal manipulation in the treatment of infantile colic . DESIGN A r and omized controlled trial . SETTING A private chiropractic practice and the National Health Service 's health visitor nurses in the suburb Ballerup ( Copenhagen , Denmark ) . SUBJECTS Infants seen by the health visitor nurses , who fulfilled the diagnostic criteria for infantile colic . INTERVENTION One group received spinal manipulation for 2 weeks , the other was treated with the drug dimethicone for 2 weeks . OUTCOME MEASURE Changes in daily hours of crying as registered in a colic diary . RESULTS By trial days 4 to 7 , hours of crying were reduced by 1 hour in the dimethicone group compared with 2.4 hours in the manipulation group ( P = .04 ) . On days 8 through 11 , crying was reduced by 1 hour for the dimethicone group , whereas crying in the manipulation group was reduced by 2.7 hours ( P = .004 ) . From trial day 5 onward the manipulation group did significantly better that the dimethicone group . CONCLUSION Spinal manipulation is effective in relieving infantile colic 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 AIM To evaluate the association between infantile colic and gastrointestinal , allergic and psychological disorders in childhood . METHODS A prospect i ve study was conducted on 103 infants aged 31 - 87 d. After 10 y , between 2001 and 2003 , the children were recalled and a paediatrician evaluated the selected disorders by anamnesis , medical examination , laboratory tests and parent interviews . RESULTS Of the 103 infants enrolled , 96 completed the study . There was an association between infantile colic and recurrent abdominal pain ( p=0.001 ) and allergic disorders : allergic rhinitis , conjunctivitis , asthmatic bronchitis , pollenosis , atopic eczema and food allergy ( p<0.05 ) . Sleep disorders , fussiness , aggressiveness and feelings of supremacy are more frequent in children who suffered from colic during early infancy ( p<0.05 ) . A family history of gastrointestinal diseases and atopic diseases was significantly higher in infants with colic than in controls ( p<0.05 ) . CONCLUSION Susceptibility to recurrent abdominal pain , allergic and psychological disorders in childhood may be increased by infantile colic . Our findings confirm that severe infantile colic might be the early expression of some of the most common disorders in childhood BACKGROUND Nonpathogenic live bacteria are consumed as food by many children , particularly in the form of yogurt . The tolerance and safety of long-term consumption of specific types and strains of probiotic bacteria are not well documented . OBJECTIVE The goal was to evaluate tolerance to formulas containing 2 levels of probiotic supplementation and effects on growth , general clinical status , and intestinal health in free-living healthy infants . DESIGN This was a prospect i ve , double-blind , r and omized , placebo-controlled study of healthy infants aged 3 - 24 mo . Infants were assigned to receive a st and ard milk-based formula containing 1 x 10(7 ) colony-forming units (CFU)/g each of Bifidobacterium lactis and Streptococcus thermophilus , formula containing 1 x 10(6 ) CFU/g each of B. lactis and S. thermophilus , or unsupplemented formula . Clinical outcomes included formula intake , gastrointestinal tolerance , anthropometric measures , daycare attendance , and history of illness . RESULTS One hundred eighteen infants aged ( + /- SD ) 7.0 + /- 2.9 mo at enrollment consumed formula for 210 + /- 127 d. There were no significant differences in age , sex , formula consumption , or length of study between groups . The supplemented formulas were well accepted and were associated with a lower frequency of reported colic or irritability ( P < 0.001 ) and a lower frequency of antibiotic use ( P < 0.001 ) than was the unsupplemented formula . There were no significant differences between groups in growth , health care attention seeking , daycare absenteeism , or other health variables . CONCLUSION Long-term consumption of formulas supplemented with B. lactis and S. thermophilus was well tolerated and safe and result ed in adequate growth , reduced reporting of colic or irritability , and a lower frequency of antibiotic use 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 We performed a prospect i ve , r and omized , double-blind , placebo-controlled clinical trial of dicyclomine hydrochloride using specific diagnostic criteria for infantile colic : spells of unexplained irritability , agitation , fussiness or crying lasting greater than or equal to 3 hours/day , occurring greater than or equal to 3 days/week , and continuing for greater than or equal to 3 weeks .  Dicyclomine eliminated colic in 15 of 24 ( 63 % ) infants , whereas placebo was effective in six of 24 ( 25 % ) ( corrected X2 = 5.42 , P = 0.02 ) . The study also addressed the hypothesis that parental distress caused by infantile colic affects subsequent temperament and sleep patterns . The data fail to document easier temperaments or longer sleep duration s at 4 months in infants whose colic ceased during treatment 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 BACKGROUND Although recent reports suggest that supplementation with probiotics may enhance intestinal function in premature infants , the mechanisms are unclear , and questions remain regarding the safety and efficacy of probiotics in extremely low-birth-weight infants . OBJECTIVE The objective was to evaluate the efficacy of probiotics on the digestive tolerance to enteral feeding in preterm infants born with a very low or extremely low birth weight . DESIGN In a bicentric , double-blind , r and omized controlled clinical trial that was stratified for center and birth weight , 45 infants received enteral probiotics ( Bifidobacterium longum BB536 and Lactobacillus rhamnosus GG ; BB536-LGG )  and 49 received placebo .  The primary endpoint was the percentage of infants receiving > 50 % of their nutritional needs via enteral feeding on the 14th day of life . A triangular test was used to perform sequential analysis . RESULTS The trial was discontinued after the fourth sequential analysis concluded a lack of effect . The primary endpoint was not significantly different between the probiotic ( 57.8 % ) and placebo ( 57.1 % ) groups ( P = 0.95 ) . However , in infants who weighed > 1000 g , probiotic supplementation was associated with a shortening in the time to reach full enteral feeding ( P = 0.04 ) . Other than colonization by the probiotic strains , no alteration in the composition of intestinal microbiota or changes in the fecal excretion of calprotectin was observed . No colonization by probiotic strains was detected in infants who weighed < or = 1000 g , presumably because of more frequent suspensions of enteral feeding , more courses of antibiotic treatment , or both . CONCLUSIONS Supplementation with BB536-LGG may not improve the gastrointestinal tolerance to enteral feeding in very-low-birth-weight infants but may improve gastrointestinal tolerance in infants weighing > 1000 g. This trial was registered at clinical trials.gov as NCT 00290576 OBJECTIVE To assess differences in family functioning or child-rearing attitudes within families with previously colicky infants and to assess whether the children differed in their behavior , development , or frequency of allergies . STUDY DESIGN A controlled , prospect i ve study with infants ( 3 months to 3 years of age ) and their families . PARTICIPANTS Three hundred thirty-eight infants with and 866 infants without exhibited colic and their families . METHODS Question naires to mothers and nurses regarding infantile colic ( 3 months of age ) ; question naires to mothers , fathers , and nurses regarding  interactions  within the family , parents ' satisfaction with daily life , child caring , child behavior , and development ( 3 years old ) ; the Denver Developmental Screening Test ( parents filled out at home during the whole 3 years of infant development ) ; the  Achenbach Behavior Checklist  for 2- to 3-year-old children ( the 3-year visit at a well baby clinic ) . RESULTS The families of previously colicky infants demonstrated more dissatisfaction with the arrangements of daily family responsibilities and with the amount of both leisure time and shared activities . The children in the colic group had more sleeping problems and more frequent temper tantrums ( at 3 years of age ) than the control group . CONCLUSIONS The families with colicky infants had more distress 3 years later . Families with colicky infants should be provided practical support in improving daily family functioning and child rearing . In addition , underlying problems in family relationships should be managed appropriately 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 ABSTRACT . The effect of Simethicone on  “ colicky ” ( n=27 ) infants was tested in a double‐blind cross‐over study . Three different parameters were used to measure the efficiency of the treatment : interviews , 24‐hour records and behavioral observations . No effects of Simethicone on the symptoms of infantile colic could be demonstrated . However , 67 % of the infants improved during the treatment , which could be ascribed to a high‐ grade placebo‐effect
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 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 .