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 - Funding Information:
The authors acknowledge the valuable contributions of NIH Program Officer Linda Duffy, PhD, MPH, for her guidance in developing and implementing this protocol under phased regulatory-approved IND, and for her support and encouragement over many years. We also thank the US Food and Drug Administration, Center for Biologics and Evaluation Research (FDA/CBER) for their assistance with regulatory approval processes. We also thank BioGaia for their invaluable assistance in the IND process and for supplying study products used in this trial. From the Peruvian side, we thank the Aso-ciación Benéfica PRISMA for its valuable support in managing the project in Peru and also the people of the Santa Clara for their support and collaboration on this Phase One study carried out in their community. The study was supported by a grant from the National Institutes of Health/National Center for Complementary and Integrative Health (formerly National Center for Complementary and Alternative Medicine) U01AT002733 and the National Institute of Diabetes and Digestive and Kidney Diseases U01DK105849 and by a training grant from the National Institutes of Health/Fogarty International Center D43TW010913. The content of this article is solely the work of the authors and does not necessarily represent the official views of the NCCIH, NIDDK or the Fogarty International Center.
Funding Information:
This work was supported by grants U01 AI-67693, U01 AI-087881, UG3 OD-023253, UH3 OD-023253, R01 AI-134940, R01 AI-137091 and R21 HL-129909 from the National Institutes of Health (Bethesda, MD). The con- tent of this manuscript is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. The authors have no conflicts of interest to disclose. Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal’s website (www.pidj.com). Address for correspondence: Dr. Kohei Hasegawa, MD, MPH, Department of Emergency Medicine, Massachusetts General Hospital, 125 Nashua Street, Suite 920, Boston, MA 02114. . E-mail: khasegawa1@partners.org. Copyright 2019 Wolters Kluwer Health, Inc. All rights reserved. DOI: 10.1097/INF.0000000000002279
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
UR - http://www.scopus.com/inward/citedby.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 -