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Clinical Trial, Phase I
Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Safety of Lactobacillus Reuteri DSM 17938 in Healthy Children 2-5 Years of Age.
Pediatric Infectious Disease Journal 2019 August
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.
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