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, Richard A Oberhelman, Margaret N Kosek, Pablo Peñataro-Yori, Maribel Paredes-Olortegui, John Lefante, Cesar Ramal-Asayag, Marcelo Zamora-Babilonia, Graciela Meza-Sanchez, Richard A 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.
Conflict of interest statement
Conflicts of Interest Statement: None of the authors have conflicts of interest to report.
Source: PubMed