WHAT'S KNOWN ON THIS SUBJECT:Chronic constipation is a common problem in childhood. In two randomized trials in adults with irritable bowel syndrome and constipation, and 1 in constipated women with a defecation frequency Ͻ3 times per week, a significant increase was shown in stool frequency in the probiotic group who used Bifidobacterium lactis DN-173 010 compared with the control group in subjects who had Ͻ3 stools per week.
WHAT THIS STUDY ADDS:In constipated children, the fermented dairy product that contained B lactis strain DN-173 010 increased stool frequency, but this increase was comparable to that of the control group. There is currently insufficient evidence to recommend fermented dairy products that contain B lactis strain DN-173 010 for these patients. abstract BACKGROUND: Constipation is a frustrating symptom affecting 3% of children worldwide. A fermented dairy product containing Bifidobacterium lactis strain DN-173 010 was effective in increasing stool frequency in constipated women. Our aim was to assess the effects of this product in constipated children. METHODS: In this prospective randomized, double-blind, controlled trial, 159 constipated children (defecation frequency Ͻ 3 times per week) were randomly allocated to receive either a fermented dairy product that contains B lactis DN-173 010 (n ϭ 79) or a control product (n ϭ 80) twice a day for 3 weeks. The primary endpoint was the change in stool frequency from baseline to after 3 weeks of product consumption. Analyses were by intention to treat. RESULTS: Eleven children did not return to any follow-up visit (5 in the probiotic group, 6 in the control group) and were therefore excluded from the final analysis. Thus, 74 children in each group were analyzed. The change in stool frequency from baseline to after 3 weeks of product consumption increased in both groups, but the difference was not statistically significant (2.9 Ϯ 3.2 in probiotic group versus 2.6 Ϯ 2.6 in control group, P ϭ .35). There were no serious adverse events. CONCLUSIONS: In constipated children, the fermented dairy product containing B lactis strain DN-173 010 did increase stool frequency, but this increase was comparable in the control group. There is currently not sufficient evidence to recommend fermented dairy products containing B lactis strain DN-173 010 in this category of patients. Future studies should focus on whether a longer period of probiotic products is more effective in children who have a short history of constipation.