Safety of Lactobacillus ReuteriDSM 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 reuteriDSM 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.