Safety of Lactobacillus Reuteri (L. Reuteri) in Healthy Adults
|ClinicalTrials.gov Identifier: NCT00922727|
Recruitment Status : Completed
First Posted : June 17, 2009
Last Update Posted : January 25, 2018
|Condition or disease||Intervention/treatment||Phase|
|Colic Gastrointestinal Tract Infections||Biological: L. reuteri Biological: Sunflower Oil||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Phase I Safety and Tolerance of Lactobacillus Reuteri in Adults|
|Study Start Date :||October 2009|
|Primary Completion Date :||July 2011|
|Study Completion Date :||July 2011|
Active Comparator: L. reuteri
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 microflora and prevention and treatment of mild diarrhea associated with GI-tract infections, travel or antibiotic treatment. The oil drops contain a dietary supplement of Lactobacillus reuteri DSM 17938.
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.
Other Name: BioGaia Drops
Placebo Comparator: Sunflower Oil
Placebo will be the equivalent number of drops of suspended sunflower oil (without LR), provided by Biogaia.
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.
Other Name: Placebo
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00922727
|United States, Texas|
|University of Texas Health Science Center at Houston|
|Houston, Texas, United States, 77030|
|Principal Investigator:||J. Marc Rhoads, M.D.||The University of Texas Health Science Center, Houston|