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Diarrhea in Preschool Children and Lactobacillus reuteri: A Randomized Controlled Trial

  • 2014-04-01
  • Pediatrics 133(4)
    • P. Gutiérrez-Castrellón
    • G. López-Velázquez
    • Luisa Díaz-García
    • C. Jiménez-Gutiérrez
    • J. Mancilla-Ramírez
    • Juliana Estevez-Jiménez
    • M. Parra

Study Design

Type
Randomized Controlled Trial (RCT)
Sample size
n = 336
Population
Healthy children aged 6-36 months attending day care centers
Methods
Randomized, double-blind, placebo-controlled trial
  • Large Human Trial
  • Highly Cited

Abstract

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.

Trial registration: ClinicalTrials.gov NCT01249911.

Keywords: Lactobacillus reuteri DSM 17938; children; diarrhea.

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