Work

A Phase One Safety Study of Lactobacillus reuteri Conducted in the Peruvian Amazon: Observations from the Field

Year: 2014

Type: article

Study designs: Randomized Controlled Trial, Clinical Trial

Abstract: Clinical research on probiotics presents challenging issues for researchers, regulators, and funding agencies, and these issues become more complex when United States federally funded research is conducted outside the United States. Here, we describe the design and results of a Phase I safety study of Lactobacillus reuteri DSM 17938 conducted as a community-based trial under the Food and Drug Administration Investigative New Drug (FDA IND) program in a small town in the Peruvian Amazon. Forty-five healthy adults 18 to 65 years of age were randomized in a 2:1 ratio to receive either Lactobacillus reuteri 10(8) organisms once daily for 5 days or an identical appearing placebo. Results showed no evidence of invasive infection resulting from probiotic administration and no differences between groups. Although we encountered several challenges in conducting an FDA-approved safety trial in this setting, the rigorously collected contextually relevant data will be very valuable to support later Phase II/III studies of L. reuteri for use in similar settings.

Source: American Journal of Tropical Medicine and Hygiene

DOI: 10.4269/ajtmh.13-0639

Authors: Richard A. Oberhelman, Margaret N. Kosek, Pablo Peñataro-Yori, Maribel Paredes-Olórtegui, Eamonn Connolly

Institutions: Tulane University, Johns Hopkins University, Prisma

Language: English

Topic: Probiotics and Fermented Foods

Subfield: Food Science

Field: Agricultural and Biological Sciences

Domain: Life Sciences

SDG: Good health and well-being

Open Access status: bronze

Funders: National Institutes of Health, U.S. Food and Drug Administration, National Center for Complementary and Integrative Health