A Phase 1 interventional study of Probiotic: Bacillus subtilis and Lactobacillus plantarum in Healthy, sponsored by University of Florida. Completed at 1 site in United States. Open to participants aged 35 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-07-10.
Sponsored by University of Florida · Phase 1, Interventional, and Basic science
The purpose of this research study is to determine whether a probiotic can change the way bile is used by the body. The investigators will also look at the effect of the probiotic on your intestinal health.
This is a randomized, double-blind, placebo controlled crossover study. After obtaining informed consent, healthy, middle-aged adults with a larger waist circumference (n=30/probiotic cross with n=90 total/study) will be randomized to one of four groups: Bacillus subtilis, Lactobacillus plantarum, Bifidobacterium animalis subsp. lactis, or placebo. Participants will consume 1 capsule per day of probiotic or placebo for 6 weeks. After a 4-week washout period, participants will be crossed to the other treatment (i.e., probiotic to placebo or placebo to probiotic).
Participants will complete daily questionnaires throughout the intervention period, and one week before and after each intervention period. Blood samples will be collected at the baseline and final time points (±3 days) of each intervention. Stool samples will be collected during the pre-baseline and final weeks of each intervention. Dietary intake will be assessed weekly during each intervention period. Gastrointestinal symptoms and physical activity questionnaires will be completed weekly during each intervention period and also the weeks before and after each intervention period.
3,512 studies on the registry are indexed under Inflammation; 640 are open to participants now.
This study's enrollment of 155 is above the median of 50 across 2,491 interventional studies indexed under Inflammation.
Browse Inflammation studies →University of Florida is the lead sponsor of 1,285 studies on the registry; 199 are open to participants now.
Of its 177 completed or terminated interventional studies of FDA-regulated products, 141 (80%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
To participate in the study you must:
Exclusion Criteria:
To participate in the study you must NOT:
Placebo will be taken once daily for 6 weeks by every subject at some point in the study (crossover design).
Dietary Supplement: Placebo
Bacillus subtilis will be taken as a capsule once daily for 6 weeks by subjects in the group receiving this supplement (group is unknown, double-blinded).
Dietary Supplement: Probiotic: Bacillus subtilis
Lactobacillus plantarum will be taken as a capsule once daily for 6 weeks by subjects in the group receiving this supplement (group is unknown, double-blinded).
Dietary Supplement: Lactobacillus plantarum
Bifidobacterium animalis will be taken as a capsule once daily for 6 weeks by subjects in the group receiving this supplement (group is unknown, double-blinded).
Dietary Supplement: Bifidobacterium animalis
Bacillus subtilis will be taken as a capsule once daily for 6 weeks by subjects in the group receiving this supplement (group is unknown, double-blinded).
Also known as: Bacillus subtilis R0179
Lactobacillus plantarum will be taken as a capsule once daily for 6 weeks by subjects in the group receiving this supplement (group is unknown, double-blinded).
Also known as: Lactobacillus plantarum HA-119
Bifidobacterium animalis will be taken as a capsule once daily for 6 weeks by subjects in the group receiving this supplement (group is unknown, double-blinded).
Also known as: Bifidobacterium animalis subsp. lactis LAFTI B94
Placebo will be taken once daily for 6 weeks by every subject at some point in the study (crossover design).
Difference in deconjugated bile acids in the blood
Levels of deconjugated bile acids in the stool and in the blood will be compared between treatment periods for each subject/group.
Time frame: Baseline #1 (Week 1) to Week 8 and Baseline #2 (Week 11) to Week 18
Satiety and glucose metabolism
Levels of hormones associated with hunger, satiety and glucose metabolism in the blood will be compared between treatment periods for each subject/group. Daily questionnaires will also assess hunger/satiety.
Time frame: Baseline #1 (Week 1) to Week 8 and Baseline #2 (Week 11) to Week 18
Inflammatory status
Levels of inflammatory markers in the blood will be compared between treatment periods for each subject/group.
Time frame: Baseline #1 (Week 1) to Week 8 and Baseline #2 (Week 11) to Week 18
The record gives a start of Aug 2013, a primary completion of Jun 2014 and a completion of Jun 2014. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Bacillus subtilis · Lactobacillus plantarum · Bifidobacterium animalis