NCT00922727

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

Phase I Safety and Tolerance of Lactobacillus Reuteri in Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Detailed description

Lactobacillus reuteri oil drops are a natural product containing Lactobacillus reuteri (LR), which has traditionally been used for the establishment and maintenance of a well-functioning gastro-intestinal (GI) tract micro flora and prevention and treatment of mild diarrhea associated with GI-tract infections. The oil drops contain a dietary supplement of Lactobacillus reuteri DSM 17938. The patients will receive 5 drops (10\^8 live organisms) by mouth daily for 60 days. Daily administration will include 5 drops (5x10\^8) of L. reuteri or placebo daily for two months. During this time,circulating peripheral blood mononuclear cell (PBMC) toll-like receptor-2 and -4 levels will be measured, along with PBMC cytokine production levels in vitro. Fecal DGGE analysis(with sequencing of bacterial rDNA) will be completed identifying changes in fecal microbiota. Inflammation in the gut will also be assessed by fecal calprotectin assay (ELISA). The time on study treatment is 2 months, with 4 months observation, for a total of 6 months. There will be 7 required visits, during which, we will assess safety and immune system effects.

Conditions

• Colic
• Gastrointestinal Tract Infections

Interventions

Type	Name	Description
BIOLOGICAL	L. reuteri	The oil drops contains 10\^8 CFU (colony forming units). As suggested by the manufacturer in the Certificate of Analysis the daily dose given to each patient will be 5 x 10\^8 CFU/ 5 drops. The dose given is within the release limit which is greater than 2 x 10\^8 CFU/ 5 drops and less than 8 x 10\^8 CFU/ 5 drops.
BIOLOGICAL	Sunflower Oil	As suggested by the manufacturer in the Certificate of Analysis the daily dose given to each patient will be 5 x 10\^8 CFU/ 5 drops.

Timeline

• Start date: 2009-10-01
• Primary completion: 2011-07-01
• Completion: 2011-07-01
• First posted: 2009-06-17
• Last updated: 2018-01-25

Locations

1 site across 1 country: United States