Safety of Lactobacillus Reuteri (L. Reuteri) in Healthy Adults
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|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|
|Actual Primary Completion Date :||July 2011|
|Actual 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|