Probiotics to improve outcomes of colic in the community: Protocol for the Baby Biotics randomised controlled trial Effectiveness of Lactobacillus reuteri in infantile colic and colicky induced maternal depression: a prospective single blind randomized trial Effects of early prebiotic and probiotic supplementation on development of gut microbiota and fussing and crying in preterm infants: a randomized, double-blind, placebo-controlled trial. Probiotic Lactobacillus rhamnosus GG therapy and microbiological programming in infantile colic: a randomized, controlled trial Treating infant colic with the probiotic Lactobacillus reuteri: double blind, placebo controlled randomised trial Lactobacillus reuteri DSM 17938 for the management of infantile colic in breastfed infants: a randomized, double-blind, placebo-controlled trial. Lactobacillus reuteri (American Type Culture Collection Strain 55730) Versus Simethicone in the Treatment of Infantile Colic: A Prospective Randomized Study Prophylactic use of a probiotic in the prevention of colic, regurgitation, and functional constipation: a randomized clinical trial. Probiotics for infantile colic: a randomized, double-blind, placebo-controlled trial investigating Lactobacillus reuteri DSM 17938. Infant distress and development of functional gastrointestinal disorders in childhood: is there a connection? Differential Calming Responses to Sucrose Taste in Crying Infants With and Without Colic Synbiotic in the management of infantile colic: a randomised controlled trial. Troublesome crying in infants: effect of advice to reduce stimulation. Effectiveness of massage, sucrose solution, herbal tea or hydrolysed formula in the treatment of infantile colic. Effectiveness of Mentha piperita in the Treatment of Infantile Colic: A Crossover Study Excessive infant crying: a controlled study of mothers helping mothers. Oral sweet solution reduces pain‐related behaviour in preterm infants Baby Business: a randomised controlled trial of a universal parenting program that aims to prevent early infant sleep and cry problems and associated parental depression Evaluation of the effect of a fiber-enriched formula on infant colic. Randomised controlled trial of swaddling versus massage in the management of excessive crying in infants with cerebral injuries Probiotic Intervention in the First Months of Life: Short-Term Effects on Gastrointestinal Symptoms and Long-Term Effects on Gut Microbiota Carrying as colic "therapy": a randomized controlled trial. Lactobacillus reuteri DSM 17938 in Infantile Colic: A Randomized, Double-Blind, Placebo-Controlled Trial
Background Infant colic , characterised by excessive crying/fussing for no apparent cause , affects up to 20 % of infants under three months of age and is a great burden to families , health professionals and the health system . One promising approach to improving its management is the use of oral probiotics . The Baby Biotics trial aims to determine whether the probiotic Lactobacillus reuteri DSM 17938 is effective in reducing crying in infants less than three months old ( < 13.0 weeks ) with infant colic when compared to placebo . Methods / Design Design : Double-blind , placebo-controlled r and omised trial in Melbourne , Australia . Participants : 160 breast and formula fed infants less than three months old who present either to clinical or community services and meet Wessel ’s criteria of crying and /or fussing . Intervention : Oral once-daily Lactobacillus reuteri ( 1x108 cfu ) versus placebo for one month . Primary outcome : Infant crying/fussing time per 24 hours at one month . Secondary outcomes : i ) number of episodes of infant crying/fussing per 24 hours and ii ) infant sleep duration per 24 hours ( at 7 , 14 , 21 , 28 days and 6 months ) ; iii ) maternal mental health scores , iv ) family functioning scores , v ) parent quality adjusted life years scores , and vi ) intervention cost-effectiveness ( at one and six months ) ; and vii ) infant faecal microbiota diversity , viii ) infant faecal calprotectin levels and ix ) Eschericia coli load ( at one month only ) . Analysis : Primary and secondary outcomes for the intervention versus control groups will be compared with t tests and non-parametric tests for continuous data and chi squared tests for dichotomous data . Regression models will be used to adjust for potential confounding factors . Intention-to-treat analysis will be applied . Discussion An effective , practical and acceptable intervention for infant colic would represent a major clinical advance . Because our trial includes breast and formula-fed babies , our results should generalise to most babies with colic . If cost-effective , the intervention ’s simplicity is such that it could be widely taken up as a new st and ard of care in the primary and secondary care sectors . Trial Registration Current Controlled Trials IS RCT 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 evaluate the impact of early prebiotic and probiotic intervention on  preterm infants ' well-being , crying , growth , and microbiological programming . STUDY DESIGN Ninety-four preterm infants ( gestational age 32 - 36 weeks and birth weight > 1500 g ) r and omized to receive prebiotics ( mixture of galacto-oligosaccharide and polydextrose 1:1 ) , probiotics ( Lactobacillus rhamnosus GG ) , or placebo during the first 2 months of life were followed up for 1 year . Infants were categorized based on the extent of crying and irritability during the first 2 months of life , and their gut microbiota was investigated by fluorescence in situ hybridization ( n = 66 ) and quantitative polymerase chain reaction ( n = 63 ) . RESULTS A total of 27 of 94 infants ( 29 % ) infants were classified as excessive criers , significantly less frequently in the prebiotic and the probiotic groups than in the placebo group ( 19 % vs 19 % vs 47 % , respectively ; P = .02 ) . The placebo group had a higher percentage of Clostridium histolyticum group bacteria in their stools than did the probiotic group ( 13.9 % vs 8.9 % , respectively ; P = .05 ) . There were no adverse events related to either supplementation . CONCLUSIONS Early prebiotic and probiotic supplementation may alleviate symptoms associated with crying and fussing in preterm infants . This original finding may offer new therapeutic and preventive measures for this common disturbance in early life Background : Probiotic Lactobacillus reuteri and reduced allergen load may lessen the daily crying of colic infants , but the role of Lactobacillus rhamnosus GG ( LGG ) has remained obscure . Methods : Infants with colic ( n = 30 ) were enrolled during the first 6 wk of life . All families received behavioral support and allergen avoidance diet :  breastfeeding mothers followed cow ’s milk elimination diet and formula-fed infants received extensively hydrolyzed casein formula . The r and omized , double-blind intervention employed of LGG 4.5 × 109 cfu/d or placebo for a 4-wk study period . Daily crying was recorded by diaries and parental interviews . Fecal calprotectin and gut microbiota composition by quantitative PCR were evaluated before and after the intervention . Results : Daily crying time was comparable between the probiotic ( 173 min ) and the placebo group ( 174 min ; P = 0.99 ) at the end of the intervention according to the parental diary . However , parents reported a decrease of 68 % ( 95 % confidence interval ( CI ) : 58–78 ) in daily crying in the probiotic and 49 % ( 95 % CI : 32–66 ) in the placebo group ( P = 0.05 ) . Conclusion : LGG in infants treated in t and em with behavioral support and a cow ’s milk elimination diet did not provide additional treatment effect for diary-verified colic crying although parental report of crying suggested the probiotic intervention effective Objective To 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 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 . 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 IMPORTANCE Infantile colic , gastroesophageal reflux , and constipation are the most common functional gastrointestinal disorders that lead to referral to a pediatrician during the first 6 months of life and are often responsible for hospitalization , feeding changes , use of drugs , parental anxiety , and loss of parental working days with relevant social consequences . OBJECTIVE To investigate whether oral supplementation with Lactobacillus reuteri DSM 17938 during the first 3 months of life can reduce the onset of colic , gastroesophageal reflux , and constipation in term newborns and thereby reduce the socioeconomic impact of these conditions . DESIGN A prospect i ve , multicenter , double-masked , placebo-controlled r and omized clinical trial was performed on term newborns ( age < 1 week ) born at 9 different neonatal units in Italy between September 1 , 2010 , and October 30 , 2012 . SETTING Parents were asked to record in a structured diary the number of episodes of regurgitation , duration of inconsolable crying ( minutes per day ) , number of evacuations per day , number of visits to pediatricians , feeding changes , hospitalizations , visits to a pediatric emergency department for a perceived health emergency , pharmacologic interventions , and loss of parental working days . PARTICIPANTS In total , 589 infants were r and omly allocated to receive L reuteri DSM 17938 or placebo daily for 90 days . INTERVENTIONS Prophylactic use of probiotic . MAIN OUTCOMES AND MEASURES Reduction of daily crying time , regurgitation , and constipation during the first 3 months of life . Cost-benefit analysis of the probiotic supplementation . RESULTS At 3 months of age , the mean duration of crying time ( 38 vs 71 minutes ; P < .01 ) , the mean number of regurgitations per day ( 2.9 vs 4.6 ; P < .01 ) , and the mean number of evacuations per day ( 4.2 vs 3.6 ; P < .01 ) for the L reuteri DSM 17938 and placebo groups , respectively , were significantly different . The use of L reuteri DSM 17938 result ed in an estimated mean savings per patient of € 88 ( US $ 118.71 ) for the family and an additional € 104 ( US $ 140.30 ) for the community . CONCLUSIONS AND RELEVANCE Prophylactic use of L reuteri DSM 17938 during the first 3 months of life reduced the onset of functional gastrointestinal disorders and reduced private and public costs for the management of this condition . TRIAL REGISTRATION clinical trials.gov Identifier : NCT01235884 OBJECTIVE To investigate the effectiveness of Lactobacillus reuteri DSM 17938 for the treatment of infantile colic in breastfed Canadian infants , compared with placebo . STUDY DESIGN A r and omized , double-blind , placebo-controlled trial was conducted involving 52 infants with colic , according to modified Wessel criteria , who were assigned at r and om to receive L reuteri DSM 17938 ( 10(8 ) colony-forming units ) ( n = 24 ) or placebo ( n = 28 ) for 21 days . Daily crying and fussing times were recorded in a structured diary , and maternal question naires were completed to monitor changes in infant colic symptoms and adverse events . RESULTS Total average crying and fussing times throughout the study ( from baseline to day 21 ) were significantly shorter among infants with colic in the probiotic group compared with infants in the placebo group ( 1719 ± 750 minutes [ 29 ± 13 hours ] vs 2195 ± 764 minutes [ 37 ± 13 hours ] ; P = .028 ) ( relative risk , 0.78 ; 95 % CI , 0.58 - 0.98 ) . Infants given L reuteri DSM 17938 showed a significant reduction in daily crying and fussing times at the end of treatment period compared with those receiving placebo ( median , 60 minutes/day [ IQR , 64 minutes/day ] vs 102 minutes/day [ IQR , 87 minutes/day ] ; P = .045 ) . On day 21 , a significantly higher proportion of infants in the L reuteri DSM 17938 group responded to treatment with a ≥50 % crying time reduction compared with infants given placebo ( 17 vs 6 , P = .035 ; relative risk , 3.3 ; 95 % CI , 1.55 - 7.03 ) . CONCLUSION Administration of L reuteri DSM 17938 significantly improved colic symptoms by reducing crying and fussing times in breastfed Canadian infants with colic Infant Distress and Development of Functional Gastrointestinal Disorders in Childhood : Is There a Connection ? One infant in 4 manifests with abundant crying , fussing , or colic cry  and is brought for medical evaluation during the first months of life.1 Concomitantly , excessive antigen uptake and bacterial translocation ensue across the immature gut barrier.2 Not surprisingly , infant crying has been related to food allergy3 and aberrant gut microbiota composition4 and these have , in turn , been linked to functional gastrointestinal disorders (FGIDs).5 We hypothesized that colic crying is associated with FGIDs later in childhood Background . 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 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 The observation that babies with troublesome crying  improve quickly in hospital suggested that , if true , a common , quickly reversible , factor may operate . Histories from parents of such babies suggest that much work goes into trying to console them . It is hypothesised that this may lead to excessive stimulation and the improvement seen in hospital reflects a reduction in stimulation . Two studies were undertaken . ( 1 ) Carers were asked to agree to r and omisation of their infants to hospital or home management . Those at home were advised to reduce stimulation . A 10 point question naire was used to describe distress in mothers of subjects and age matched controls . ( 2 ) A r and omised controlled study compared advice to reduce stimulation with an empathic interview  using a + 5 to -5 scale to chart change . In the first study too few subjects agreed to r and omisation and thus a rigorous study to vali date the observation could not proceed . There was good evidence , however , that crying improved . Results from the home group justified the second study . The median distress score for subjects was 7/10 and for controls 3/10 ( p less than 0.001 ) . In the second study at seven days , 18/22 subjects given advice scored + 2 or better on the change chart for crying , compared with 7/20 of those who did not receive advice ( p less than 0.01 ) . After the latter received advice 79 % improved ( 95 % confidence interval 61 to 97 % ) . For babies under 12 weeks , the customary upper limit for a diagnosis of colic , 14/15 subjects advised improved compared with 6/12 who were not advised ( p less than 0.02 ) . These studies have shown that infants with troublesome crying admitted to hospital seem to improve quickly as do those whose carers are advised to reduce stimulation 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 . 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 OBJECTIVE To determine the efficacy of behavioral management counseling in the treatment of persistent , excessive infant crying ( > 3 hours per day ) . DESIGN Two treatments , one no treatment control group . Infants were group-matched according to baseline fuss/cry levels , sociodemographic , and infant variables . Treatments were carried out sequentially by the same counselors . SETTING Telephone counseling by volunteers ( mothers ) of CRY-SIS , a national support group for the parents of crying infants . PATIENTS AND INTERVENTIONS Sequential sample of 27 mother-infant pairs receiving treatment 1 ( Tr1 , empathy : talking through the problem ) , 21 receiving treatment 2 ( Tr2 , behavioral management : specific care taking suggestions ) and 44 receiving no treatment ( C , controls ) . Infants were between 1 to 5 months of age . MEASUREMENTS AND RESULTS Mother-infant pairs had a pretreatment baseline assessment and a posttreatment follow-up ( 3 months after baseline ) using 1-week diaries . Total fuss/cry duration reduced significantly more in the behavioral management group ( by 51 % ) than the empathy group ( 37 % ) or the control group ( 35 % ) . This was mainly due to significantly reduced evening fussing/crying in Tr2 ( 67 % ) compared with Tr1 ( 45 % ) and C ( 42 % ) . No differences in total number of fuss/cry bouts/day were found . However , the number of fuss/cry bouts reduced significantly more in the evening in Tr2 ( by 55 % ) compared with Tr1 ( 27 % ) and C ( 32 % ) . Behavioral management mothers evaluated the same counselors as more sympathetic , knowledgeable , and underst and ing . Tr2 was also perceived by mothers to have helped them more in reducing the crying problem , coping with the infant , and improving the relationship with their infant than Tr1 . No effects of treatment on infant difficult temperament were found . CONCLUSIONS Behavioral management was more effective in reducing fussing/crying than spending time with the mother talking through the problem or just waiting for spontaneous remission . Treatment by suitably but briefly trained lay counselors is an inexpensive and successful treatment option To evaluate the effectiveness of oral sucrose in the prevention of pain‐induced crying in preterm infants , a sample of 28 healthy neonates ( 15 M , 13F ; gestational age at procedure less than 37 weeks ) who were having routine blood drawn by arm venipuncture was studied . Infants were r and omly allocated to receive by mouth , using a syringe , 2 ml of one of three solutions : spring water ( group W ) and sucrose 12 and 24 % w/v ( groups S12 and S24 , respectively ) , all in water vehicle . After 2 min , while awake , arm venipuncture was performed and duration of crying was measured . The time spent crying was reduced in the group treated with the sweetest solution ( S24 , n= 8 , mean = 19.1 s ) . No difference was observed between the S12 group ( n= 8 , mean = 63.1 s ) and W group ( n= 12 , mean = 72.9 s ) . Physiological measurements were recorded at different time points to evaluate excessive basal and procedural distress Background Infant crying and sleep problems ( e.g. frequent night waking , difficulties settling to sleep ) each affect up to 30 % of infants and often co-exist . They are costly to manage and associated with adverse outcomes including postnatal depression symptoms , early weaning from breast milk , and later child behaviour problems . Preventing such problems could improve these adverse outcomes and reduce costs to families and the health care system . Anticipatory guidance-i.e . providing parents with information about normal infant sleep and cry patterns , ways to encourage self-settling in infants , and ways to develop feeding and settling routines before the onset of problems-could prevent such problems . This paper outlines the protocol for our study which aims to test an anticipatory guidance approach . Methods / Design 750 families from four Local Government Areas in Melbourne , Australia have been r and omised to receive the  Baby Business program ( intervention group ) or usual care ( control group ) offered by health services . The Baby Business program provides parents with information about infant sleep and crying via a DVD and booklet ( mailed soon after birth ) , telephone consultation ( at infant age 6 - 8 weeks ) and parent group session ( at infant age 12 weeks ) . All English speaking parents of healthy newborn infants born at > 32 weeks gestation and referred by their maternal and child health nurse at their first post partum home visit ( day 7 - 10 postpartum ) , are eligible . The primary outcome is parent report of infant night time sleep as a problem at four months of age and secondary outcomes include parent report of infant daytime sleep or crying as a problem , mean duration of infant sleep and crying/24 hours , parental depression symptoms , parent sleep quality and quantity and health service use . Data will be collected at two weeks ( baseline ) , four months and six months of age . An economic evaluation using a cost-consequences approach will , from a societal perspective , compare costs and health outcomes between the intervention and control groups . Discussion To our knowledge this is the first r and omised controlled trial of a program which aims to prevent both infant sleeping and crying problems and associated postnatal depression symptoms . If effective , it could offer an important public health prevention approach to these common , distressing problems . Trial registration numberIS RCT N : IS RCT 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 Background : Infants with neonatal cerebral insults are susceptible to excessive crying as a result of difficulties with self-regulation . Aims : To compare the effectiveness of swaddling versus massage therapy in the management of excessive crying of infants with cerebral insults . Methods : R and omised three-week parallel comparison of the efficacy of two intervention methods . Infants with symptoms of troublesome crying and their parents were r and omly assigned to a swaddling intervention group ( n = 13 ) or a massage intervention group ( n = 12 ) . Results : The amount of total daily crying decreased significantly in the swaddling group , but did not decrease significantly in the massage group . Infant behavioural profiles and maternal anxiety levels improved significantly in the swaddling group post-intervention . Parents in the swaddling group were more satisfied with the effectiveness of the intervention in reducing crying than parents in the massage group . Conclusion : Results indicate that swaddling may be more effective than massage intervention in reducing crying in infants with cerebral injuries Objectives : To determine whether probiotics administered for 6 months postnatally affect  gastrointestinal symptoms , crying  and the compositional development of the gut microbiota through infancy . Methods : The study comprised of 132 newborns whose mothers were r and omized to receive placebo or Lactobacillus rhamnosus GG ( ATCC 53103 ) before delivery . The treatments of mothers/infants continued for 6 months postnatally . A specific symptom chart was used to monitor gastrointestinal symptoms and infant 's crying during the 7th and the 12th weeks of life . Fluorescent in situ hybridization was used to establish the Bifidobacterium , Lactobacillus/Enterococcus , Bacteroides and Clostridium counts in fecal sample s at 6 , 12 , 18 and 24 months of age . Results : Numbers of different types of stools , vomits and crying time were comparable between the groups during the 7th and the 12th weeks of life . Dominant microbiota consisted of bifidobacteria throughout the study . At 6 months , there were less clostridia in faeces in the placebo compared with the probiotic group ( P = 0.026 ) , whereas after long-term follow-up at 2 years , there were less lactobacilli/enterococci and clostridia in faeces in the probiotic group than in the placebo group ( P = 0.011 and P = 0.032 , respectively ) , reflecting the impact of clostridia as a marker of microbiota succession in healthy infants . Conclusions : Probiotic administration in the first months of life was well tolerated and did not significantly interfere with long-term composition or quantity of gut microbiota In healthy infants , crying behavior is reduced significantly by " supplemental " carrying ; that is , increased carrying throughout the day in addition to that which occurs during feeding and in response to crying . To determine whether the recommendation to increase carrying would be effective as a therapy for colic , 66 mothers of infants 4 weeks of age or less who came to their pediatricians with complaints of crying problems ( " colic " ) were r and omized to receive st and ard pediatric advice (  st  and ard group ) or st and ard advice plus the recommendation to increase supplemental carrying by 50 % ( supplemental group ) . Overall , the supplemental group carried their infants 6.1 hours/d throughout the intervention period , an increase of 2.2 hours/d ( 56 % ) more than that provided by the st and ard group . Despite this significant increase in carrying , there was no difference between groups in the duration or frequency of crying , fussing , or cry/fuss at any time throughout the intervention period . When the greatest treatment effect was expected at 6 weeks , the supplemental group infants cried only 3 minutes less per day ( 95 % confidence interval : 37 minutes less to 32 minutes more per day ) . We conclude that , compared with st and ard pediatric advice to be " responsive , " supplemental carrying does not reduce crying and fussing behavior further in infants who have colic . In marked contrast to healthy infants , this apparent resistance to increased carrying may indicate an important difference in state regulation and control in infants with colic 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
AND RELEVANCE Although L reuteri may be effective as treatment for crying in exclusively breastfed infants with colic , there is still insufficient evidence to support probiotic use to manage colic , especially in formula-fed infants , or to prevent infant crying .
IMPORTANCE  Excessive infant crying  is common , distressing , but without proven effective prevention or management options .
Probiotics may be a promising solution .
OBJECTIVE To examine whether probiotics are effective in the prevention/management of crying ( " colic " ) in infants 3 months or younger .