TY - JOUR
T1 - Safety of Lactobacillus Reuteri DSM 17938 in Healthy Children 2-5 Years of Age
AU - Kosek, Margaret N.
AU - Peñataro-Yori, Pablo
AU - Paredes-Olortegui, Maribel
AU - Lefante, John
AU - Ramal-Asayag, Cesar
AU - Zamora-Babilonia, Marcelo
AU - Meza-Sanchez, Graciela
AU - Oberhelman, Richard A.
N1 - Publisher Copyright:
© 2019 Wolters Kluwer Health, Inc. All rights reserved.
PY - 2019/8/1
Y1 - 2019/8/1
N2 - 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.
AB - 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.
KW - Lactobacillus reuteri
KW - clinical trials
KW - diarrhea
KW - probiotics
UR - http://www.scopus.com/inward/record.url?scp=85069888975&partnerID=8YFLogxK
U2 - 10.1097/INF.0000000000002267
DO - 10.1097/INF.0000000000002267
M3 - Article
C2 - 30531312
AN - SCOPUS:85069888975
SN - 0891-3668
VL - 38
SP - E178-E180
JO - Pediatric Infectious Disease Journal
JF - Pediatric Infectious Disease Journal
IS - 8
ER -
