Open AccessSafety of Lactobacillus Reuteri DSM 17938 in Healthy Children 2–5 Years of Age
Author(s) -
Margaret Kosek,
Pablo Peñataro-Yori,
Maribel Paredes Olórtegui,
John J. Lefante,
César Ramal-Asayag,
Marcelo Zamora-Babilonia,
Graciela Meza Sánchez,
Richard A. Oberhelman
Publication year - 2019
Publication title -
the pediatric infectious disease journal/the pediatric infectious disease journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.028
H-Index - 140
eISSN - 1532-0987
pISSN - 0891-3668
DOI - 10.1097/inf.0000000000002267
Subject(s) - lactobacillus reuteri , diarrhea , placebo , medicine , food and drug administration , adverse effect , drug , pediatrics , probiotic , intensive care medicine , environmental health , psychiatry , alternative medicine , biology , genetics , pathology , bacteria
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.