Safety of Lactobacillus Reuteri in Healthy Children Ages 2 to 5 Years in Peru

Phase 1 Completed 60 enrolled Tulane University School of Medicine Asociacion Benefica Prisma · collab Johns Hopkins Bloomberg School of Public Health · collab National Center for Complementary and Integrative Health (NCCIH) · collab

RandomizedParallel-groupTriple-blindTreatment

Summary

This is a Phase 1 study to assess the safety and tolerability of Lactobacillus reuteri (Lr) strain DSM 17938 in healthy children in Peru. It is a preliminary study in support of a clinical trial to assess safety and efficacy of L. reuteri for treatment of pediatric diarrhea in Peru.

Timeline

Start: 2015-03
Primary completion: 2015-11
Completion: 2016-01

Publications

Kosek MN, Penataro-Yori P, Paredes-Olortegui M, Lefante J, Ramal-Asayag C, Zamora-Babilonia M, Meza-Sanchez G, Oberhelman RA. Safety of Lactobacillus Reuteri DSM 17938 in Healthy Children 2-5 Years of Age. Pediatr Infect Dis J. 2019 Aug;38(8):e178-e180. doi: 10.1097/INF.0000000000002267.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lactobacillus reuteri	Other / unclassified	1e+08 cells	—

Indications

No indication recorded.