Title
Safety of Lactobacillus Reuteri DSM 17938 in Healthy Children 2-5 Years of Age
Date Issued
01 August 2019
Access level
open access
Resource Type
journal article
Author(s)
Peñataro-Yori P.
Lefante J.
Zamora-Babilonia M.
Oberhelman R.A.
Publisher(s)
Lippincott Williams and Wilkins
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.
Start page
E178
End page
E180
Volume
38
Issue
8
Language
English
OCDE Knowledge area
Pediatría
Gastroenterología, Hepatología
Subjects
Scopus EID
2-s2.0-85069888975
PubMed ID
Source
Pediatric Infectious Disease Journal
ISSN of the container
08913668
Sponsor(s)
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.
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
Sources of information:
Directorio de Producción Científica
Scopus