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Clinical Trial
. 2019 Aug;38(8):e178-e180.
doi: 10.1097/INF.0000000000002267.

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

Margaret N Kosek  1 , Pablo Peñataro-Yori  2 , Maribel Paredes-Olortegui  2 , John Lefante  3 , Cesar Ramal-Asayag  2 , Marcelo Zamora-Babilonia  2 , Graciela Meza-Sanchez  2 , Richard A Oberhelman  3
Affiliations
Clinical Trial

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

Margaret N Kosek et al. Pediatr Infect Dis J. 2019 Aug.

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.

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Conflict of interest statement

Conflicts of Interest Statement: None of the authors have conflicts of interest to report.

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