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

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish (US)
Pages (from-to)E178-E180
JournalPediatric Infectious Disease Journal
Volume38
Issue number8
DOIs
StatePublished - Aug 1 2019

Keywords

  • Lactobacillus reuteri
  • clinical trials
  • diarrhea
  • probiotics

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health
  • Microbiology (medical)
  • Infectious Diseases

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