Safety of Lactobacillus Reuteri (L. Reuteri) in Healthy Adults
| Status: | Completed |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 60 |
| Updated: | 1/27/2018 |
| Start Date: | October 2009 |
| End Date: | July 2011 |
Phase I Safety and Tolerance of Lactobacillus Reuteri in Adults
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.
(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.
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.
Inclusion Criteria:
- Healthy Adults (18 - 60 years old)
- No other recognized illness
Exclusion Criteria:
- Pregnancy or breastfeeding
- Patient taking immunosuppressive medications, including oral corticosteroids
- Positive result of HIV, Hepatitis B, and/or Hepatitis C test
- Abnormal lab test results
- Gastrointestinal related diseases and surgeries
- Patients with an allergy to antibiotics
- Presence of fever or a pre-existing adverse event monitored in the study
- No more than two study participants in one household
- Use of probiotics in the last 90 days
- Diarrheal illness within the past 30 days
- Recent or current use of oral antibiotics /anti-fungals(in the past 2 weeks)
- Current use of oral laxatives
- Chronic alcohol use or more than 1 drink per day
- Subjects with implanted prosthetic devices including prosthetic heart valves
- Known sensitivity to sunflower oil or products containing linolenic/oleic acids
- Will require that subject not take any other probiotic-containing products, including
yogurt supplemented with probiotics during the 6-month period
We found this trial at
1
site
7000 Fannin St
Houston, Texas 77030
Houston, Texas 77030
(713) 500-4472
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
Click here to add this to my saved trials
