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Safety of Lactobacillus reuteri DSM 17938 in Healthy Children 2 to 5 Years of Age.

  • 2019-08
  • Pediatric Infectious Disease Journal 38(8)
    • M. Kosek
    • Pablo Peñataro-Yori
    • Maribel Paredes-Olórtegui
    • J. Lefante
    • César Ramal-Asayag
    • Marcelo Zamora-Babilonia
    • Graciela Meza-Sánchez
    • R. Oberhelman

Abstract

Probiotics are increasingly used for diarrhea, but studies under the Food and Drug Administration and Investigational New Drug program are few. We conducted a phase-one placebo-controlled study of Lactobacillus reuteri DSM 17938 under Investigational New Drug program in 60 children 2-5 years of age (41 L. reuteri, 19 placebos) in a resource-constrained community in Peru. No differences in objective data on adverse events were noted, although some differences based on subjective parental reports for fever and diarrhea were seen.

Trial registration: ClinicalTrials.gov NCT02124122.

Research Insights

SupplementHealth OutcomeEffect TypeEffect Size
Lactobacillus reuteri DSM 17938Reduced Incidence of Adverse EventsNeutral
Small
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