The Efficacy of The Administration of BifidobacteriumLactis For Treatment of Infantile Colic: A Double-Blind, Randomized, Placebo-Controlled Clinical Trial

Abstract The aim of this trial was to evaluate the efficacy of Bifidobacterium Lactis administration on infantile colic (IC). In this double blind randomized, placebo‐controlled clinical trial, infants with IC diagnosis, exclusive breastfeeding, gestational age more than 37 weeks and birth weight more than 2500 gram were included. The selected infants randomly allocated in the two groups of BBcare group, treated with Bifidobacterium animalis subsp. lactis and the control group treated with placebo, 5 drops per day, for 6 weeks. The mean of crying, vomiting episodes and defecation number at baseline and during follow ups (40 and 60 days after intervention) were compared between the two studied groups. In this study from initially enrolled neonates, 40 and 38 neonates in BB-12 and placebo groups completed the study. In BB-12 group number of defecation, crying and vomiting episodes decreased significantly during intervention till 60 days after probiotic administration(P<0.05).In the placebo group there was significant decrease for crying and vomiting episodes between baseline and 60 days after intervention(P<0.05). Between group analyses indicated that there was significant difference between groups regarding mean of crying and vomiting episodes and number of defecation ,60 days after intervention(P<0.05).Conclusion: Findings of our study offer compelling signals for the effectiveness of Bifidobacterium animalis subsp. lactis BB‐12 in the management of some intestinal problems. These findings could be supportive evidences for the important role of gut microbiota as goal of intervention to improvement in bowel movement and comfortable defecation in IC.