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

Margaret 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 journalArticle

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
JournalThe Pediatric infectious disease journal
Volume38
Issue number8
DOIs
StatePublished - Aug 1 2019

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Lactobacillus reuteri
Investigational Drugs
Diarrhea
Placebos
Safety
Peru
Probiotics
United States Food and Drug Administration
Fever

ASJC Scopus subject areas

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

Cite this

Kosek, M., Peñataro-Yori, P., Paredes-Olortegui, M., Lefante, J., Ramal-Asayag, C., Zamora-Babilonia, M., ... Oberhelman, R. A. (2019). Safety of Lactobacillus Reuteri DSM 17938 in Healthy Children 2-5 Years of Age. The Pediatric infectious disease journal, 38(8), e178-e180. https://doi.org/10.1097/INF.0000000000002267

Safety of Lactobacillus Reuteri DSM 17938 in Healthy Children 2-5 Years of Age. / Kosek, Margaret; Peñataro-Yori, Pablo; Paredes-Olortegui, Maribel; Lefante, John; Ramal-Asayag, Cesar; Zamora-Babilonia, Marcelo; Meza-Sanchez, Graciela; Oberhelman, Richard A.

In: The Pediatric infectious disease journal, Vol. 38, No. 8, 01.08.2019, p. e178-e180.

Research output: Contribution to journalArticle

Kosek, M, Peñataro-Yori, P, Paredes-Olortegui, M, Lefante, J, Ramal-Asayag, C, Zamora-Babilonia, M, Meza-Sanchez, G & Oberhelman, RA 2019, 'Safety of Lactobacillus Reuteri DSM 17938 in Healthy Children 2-5 Years of Age', The Pediatric infectious disease journal, vol. 38, no. 8, pp. e178-e180. https://doi.org/10.1097/INF.0000000000002267
Kosek M, Peñataro-Yori P, Paredes-Olortegui M, Lefante J, Ramal-Asayag C, Zamora-Babilonia M et al. Safety of Lactobacillus Reuteri DSM 17938 in Healthy Children 2-5 Years of Age. The Pediatric infectious disease journal. 2019 Aug 1;38(8):e178-e180. https://doi.org/10.1097/INF.0000000000002267
Kosek, Margaret ; Peñataro-Yori, Pablo ; Paredes-Olortegui, Maribel ; Lefante, John ; Ramal-Asayag, Cesar ; Zamora-Babilonia, Marcelo ; Meza-Sanchez, Graciela ; Oberhelman, Richard A. / Safety of Lactobacillus Reuteri DSM 17938 in Healthy Children 2-5 Years of Age. In: The Pediatric infectious disease journal. 2019 ; Vol. 38, No. 8. pp. e178-e180.
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