• Pediatr. Infect. Dis. J. · Aug 2019

    Randomized Controlled Trial

    Safety of Lactobacillus Reuteri DSM 17938 in Healthy Children 2-5 Years of Age.

    • Margaret N Kosek, Pablo Peñataro-Yori, Maribel Paredes-Olortegui, John Lefante, Cesar Ramal-Asayag, Marcelo Zamora-Babilonia, Graciela Meza-Sanchez, and Richard A Oberhelman.
    • From the Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.
    • Pediatr. Infect. Dis. J. 2019 Aug 1; 38 (8): e178-e180.

    AbstractProbiotics 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.

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