The Efficacy of the Administration of Bifidobacterium lactis for Treatment of Infantile Colic: A Double-Blind, Randomized, Placebo-Controlled Clinical Trial.

BACKGROUND: Although there is evidence regarding the effectiveness of probiotics for infantile colic (IC), there are not many studies regarding the efficacy of Bifidobacterium animalis subsp. Lactis BB-12®, (BB-12®), for the treatment of IC. This trial aimed to evaluate the efficacy of this subspecies of probiotic administration on IC. MATERIALS AND METHODS: In this double-blind randomized, placebo-controlled clinical trial, infants with IC diagnosis, exclusive breastfeeding, gestational age of more than 37 weeks, and birth weight of more than 2500 grams were included. The selected infants were randomly allocated into the two groups of "BBcare" group, treated with BB-12® and the control group was treated with a placebo, 5 drops per day, for 6 weeks. The mean of crying time, vomiting episodes, and frequency of defecation at baseline and during follow-ups (40 and 60 days after intervention) were compared between the two studied groups. RESULTS: In this study, 40 and 38 neonates in "BBcare" and placebo groups completed the study. In the "BBcare" group frequency of defecation, crying time, and vomiting episodes decreased significantly during intervention till 60 days after probiotic administration (P < 0.05). In the placebo group, there was a significant increase in crying and vomiting episodes between baseline and 60 days after intervention (P < 0.05). Between-group analyses indicated that mean of crying time, and vomiting episodes and number of defecations, 60 days after intervention were significantly lower in "BBcare" group (P < 0.05). CONCLUSION: The findings of our study offer compelling signals for the effectiveness of BB-12® in the management of some intestinal problems. Although these findings could be supportive evidence for the important role of gut microbiota as the goal of intervention to improve bowel movement and comfortable defecation in IC, further studies are needed in this field, especially for the evaluation of different types of probiotics in combination with each other's and with different dosages.