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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
40
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.
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.
University of Texas Health Science Center at Houston
Houston, Texas, United States
Treatment of adults with probiotic (health-promoting bacteria) LR, will be safe and well-tolerated.
Time frame: 8/1/2009 - 7/1/2009
Determine if LR treatment affects circulating levels of pro-inflammatory and anti-inflammatory cytokines, along with expression levels of toll like receptors (TLRs)-2 and -4 in circulating peripheral blood mononuclear cells.
Time frame: 4/1/2009-7/1/2009
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