Safety of Lactobacillus Reuteri (L. Reuteri) in Healthy Adults

Phase 1 Completed 40 enrolled The University of Texas Health Science Center, Houston National Center for Complementary and Integrative Health (NCCIH) · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study will evaluate the safety and tolerability of the probiotic Lactobacillus reuteri (LR) in healthy adult patients. Patients will be randomized to receive either LR or placebo orally each day for a total of 60 doses. The effects on fecal bacteria, circulating white blood cell receptors and inflammatory cytokine profiles will be measured.

Timeline

Start: 2009-10
Primary completion: 2011-07
Completion: 2011-07

Publications

Results Mangalat N, Liu Y, Fatheree NY, Ferris MJ, Van Arsdall MR, Chen Z, Rahbar MH, Gleason WA, Norori J, Tran DQ, Rhoads JM. Safety and tolerability of Lactobacillus reuteri DSM 17938 and effects on biomarkers in healthy adults: results from a randomized masked trial. PLoS One. 2012;7(9):e43910. doi: 10.1371/journal.pone.0043910. Epub 2012 Sep 6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Lactobacillus reuteri	Other / unclassified	5e+08 cells	Oral

Safety of Lactobacillus Reuteri (L. Reuteri) in Healthy Adults

Summary

Timeline

Publications

Drugs

Indications