Diarrhea in preschool children and Lactobacillus reuteri: a randomized controlled trial.

OBJECTIVES To evaluate whether daily administration of Lactobacillus reuteri DSM 17938 reduces the frequency and duration of diarrheal episodes and other health outcomes in day school children in Mexico. METHODS Healthy children (born at term, aged 6-36 months) attending day care centers were enrolled in this randomized, double-blind, placebo-controlled trial. They received L reuteri DSM 17938 (dose 10(8) colony-forming unit; n = 168) or identical placebo (n = 168) by mouth, daily for 3 months, after which they were followed-up after a further 3 months without supplementation. RESULTS Data from all children were included in the final analysis. L reuteri DSM 17938 significantly reduced the frequency and duration of episodes of diarrhea and respiratory tract infection at both 3 and 6 months (P < .05). Additionally, the number of doctor visits, antibiotic use, absenteeism from day school and parental absenteeism from work were significantly reduced in the L reuteri group (P < .05). A cost-benefit analysis revealed significant reductions in costs in the L reuteri-treated children. No adverse events related to the study product were reported. CONCLUSIONS In healthy children attending day care centers, daily administration of L reuteri DSM 17938 had a significant effect in reducing episodes and duration of diarrhea and respiratory tract infection, with consequent cost savings for the community.