The Pediatric infectious disease journal
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Pediatr. Infect. Dis. J. · Aug 2019
Randomized Controlled TrialSafety of Lactobacillus Reuteri DSM 17938 in Healthy Children 2-5 Years of Age.
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.