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 .
Treating infant colic with the probiotic Lactobacillus reuteri: double blind, placebo controlled randomised trial
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
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 .