EXTERNAL SITE MONITORING FOR PRIDEC-PERU STUDIES

Westat, Inc., Rockville MD

Investigators

Abstract

The Probiotics to Reduce Impact of Diarrhea and Enteropathy in Children-Peru (PRIDEC-Peru) is a series of clinical and community research studies funded as a cooperative agreement to study the safety, tolerability and efficacy of a probiotic in children under the age of two years in the Peruvian Amazon where diarrhea and chronic malnutrition are common. The PRIDEC-Peru studies are a continuation of a program of clinical research that was initially funded by the National Center for Complementary and Integrative Health (NCCIH) in 2008. The NCCIH-funded studies include Safety of Lactobacillus reuteri in Healthy Volunteers / ClinicalTrials.gov NCT00774163 and Safety of Lactobacillus reuteri in Healthy Children Ages 2 to 5 Years in Peru / ClinicalTrials.gov NCT02124122.