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 [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]. Infant distress and development of functional gastrointestinal disorders in childhood: is there a connection? Reduction of crying episodes owing to infantile colic: a randomized controlled study on the efficacy of a new infant formula New strategies for the treatment of colic: modifying the parent/infant interaction. Differential Calming Responses to Sucrose Taste in Crying Infants With and Without Colic Effectiveness of Lactobacillus reuteri in infantile colic and colicky induced maternal depression: a prospective single blind randomized trial Synbiotic in the management of infantile colic: a randomised controlled trial. Lactobacillus reuteri DSM 17938 for the management of infantile colic in breastfed infants: a randomized, double-blind, placebo-controlled trial. Probiotics for infantile colic: a randomized, double-blind, placebo-controlled trial investigating Lactobacillus reuteri DSM 17938. A prospective 10-year study on children who had severe infantile colic. Infantile colic: crying time reduction with a whey hydrolysate: A double-blind, randomized, placebo-controlled trial. Treatment of infantile colic with dicyclomine hydrochloride. Evaluation of the effect of a fiber-enriched formula on infant colic. Prophylactic use of a probiotic in the prevention of colic, regurgitation, and functional constipation: a randomized clinical trial. Effectiveness of massage, sucrose solution, herbal tea or hydrolysed formula in 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 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 Infant Distress and Development of Functional Gastrointestinal Disorders in Childhood : Is There a Connection ? One infant in 4 manifests with abundant crying , fussing , or colic cry  and is brought for medical evaluation during the first months of life.1 Concomitantly , excessive antigen uptake and bacterial translocation ensue across the immature gut barrier.2 Not surprisingly , infant crying has been related to food allergy3 and aberrant gut microbiota composition4 and these have , in turn , been linked to functional gastrointestinal disorders (FGIDs).5 We hypothesized that colic crying is associated with FGIDs later in childhood 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 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 Background . Colic is a behavioral syndrome of early infancy of unknown etiology whose core symptom is increased  crying . Both clinical anecdotal descriptions and controlled observations converge in suggesting that a defining characteristic of the crying behavior is the longer duration of the crying bouts , especially during the second month of life when colic is at its peak . This implies that , once infants with colic begin crying , they do not calm as well as infants without colic . To investigate this difference objective ly , we used response to sucrose taste as a probe of colic-normal differences in regulation of crying for three reasons . First , sucrose taste has been shown to be a potent regulator of crying in human newborns . Second , convergent evidence from studies in both nonhuman and human infants suggests that sucrose calming reflects the function of central distress regulatory systems that are opioid-dependent . Third , effectiveness of sucrose calming diminishes in normal infants by 4 to 6 weeks of age , consistent with the developmental increase in crying duration common to infants with and without colic . Consequently we predicted that , if the regulation of crying by sucrose taste is relevant to the crying of infants with colic , calming responses to sucrose taste should be less effective in 6-week-old infants with colic compared with those without . Objectives . To investigate the clinical observation that infants with and without colic differ in their ability to regulate their crying behavior , our primary objective was to determine if there were differential crying responses to intraoral sucrose tastes ( relative to water ) in crying infants with and without colic . Based on previous studies of calming responses to sucrose taste , it was predicted that sucrose-specific calming before a feeding would be less effective in infants with colic than in those without . A secondary and more exploratory aim was to assess calming responses to sucrose ( relative to water ) on spontaneous crying after a feed in both groups . Methods . Nineteen infants meeting modified Wessel 's criteria for colic were compared with 19 age- and sex-matched normal infants without colic in a within-subject controlled observation of calming and mouthing responses to both intraoral sucrose and water tastes . Both before and after two feedings on the same day , each infant was observed until she or he cried continuously for 15 consecutive seconds , at which time three 250-μL tastes of 48 % sucrose solution or sterile water were administered 30 seconds apart , and infant responses videotaped . Outcome measures derived from second-by-second coding of the videorecordings were percent time crying per minute for 4 minutes and percent time mouthing per minute for 2 minutes after stimulus administration . Results . As predicted , the crying of infants with colic was less affected than the crying of infants without colic after sucrose but not water tastes before feedings . After feedings , the crying of infants with colic was less affected than the crying of infants without colic for both sucrose and water tastes , and sucrose was more effective than water in both groups of infants . These calming differences could not be attributed to differences in mouthing responses because the calming effects persisted after mouthing ceased , and there were no differences in mouthing responses between groups before or after feedings . Conclusions . As in newborns , a significant calming effect of sucrose taste that persisted beyond the cessation of mouthing could be elicited in crying 6-week-old infants , but it required a stronger taste stimulus to do so . As predicted , infants with colic were less effectively calmed by sucrose taste than infants without . These differential effects could not be accounted for by differences in crying when the stimulus was applied or by differences in mouthing behavior . Before a feed , these differences in calming were specific to sucrose taste . After a feed , infants with colic were calmed less by both sucrose and water . These results imply that a defining individual difference of infants with colic is that they are less able to regulate crying once started and that the regulatory effects of sucrose taste are reduced in infants with colic . In light of evidence that sucrose-induced calming may be mediated by central opioid-dependent systems , the reduced calming effectiveness may be indexing a functional difference in a central opioid-dependent calming system in 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 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 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 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 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 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 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 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 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 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
Probiotics , fennel extract  and  spinal manipulation  show promise to alleviate symptoms of colic , although some concerns remain .
Background Infantile colic is a distressing condition characterised by excessive crying in the first few months of life .
The aim of this research was to up date the synthesis of evidence of complementary and alternative medicine ( CAM ) research literature on infantile colic and establish what evidence is currently available .