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| ID | Type | Description | Link |
|---|---|---|---|
| OCR18441 | Other Identifier | University of Florida |
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| Name | Class |
|---|---|
| Lallemand Health Solutions | INDUSTRY |
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In this double blind, crossover study participants will take a placebo for 3 weeks each. Gut permeability will be assessed weekly using food-grade sugar molecules. On the second week, participants will take aspirin, which will make their intestine permeable to the sugars. Participants will be asked to provide urine and stool samples to assess gut permeability and microbial communities. No change in permeability to the small sugar probes is anticipated with the probiotic.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic | Experimental | 2 capsules daily for 3 weeks, containing 3.8 x 10^9 CFU (colony forming units)/capsule of Lactobacillus rhamnosus strain R011and 0.2 x 10^9 CFU/capsule of L. helveticus strain R0052 (group is unknown, double blinded) |
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| Placebo | Placebo Comparator | 2 capsules daily for 3 weeks containing the same carrier material and is similar in size, shape and taste to probiotic (group is unknown, double blinded) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic | Dietary Supplement | This probiotic is commercially available and contains L. helveticus R0052 (0.2 x 10^9 CFU/capsule) and L. rhamnosus R0011 (3.8 x 10^9 CFU/capsule) as active ingredients and ascorbic acid, hypromellose, magnesium stearate, saccharose, potato starch, titanium dioxide, and maltodextrin as excipients. |
| Measure | Description | Time Frame |
|---|---|---|
| Gastroduodenal Permeability | The primary outcome is the difference between the changes in gastroduodenal permeability induced by aspirin challenge with the probiotic versus the placebo. Gastroduodenal permeability will be assessed while on the placebo and probiotic interventions by measuring urinary sucrose in the 0 to 5-hour urine collection of the sugar probe permeability test. Change will be calculated as the urinary sucrose concentration after aspirin challenge (week 2 of each intervention) minus the concentration from the prior week (i.e., 1 wk on intervention with no aspirin challenge). | Week 2 of each intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Small Intestinal Permeability | Difference between the changes (week 2 of intervention with aspirin minus week 1 of intervention without aspirin) in urinary lactulose/rhamnose ratio in the 0 to 5-hour urine collection with the probiotic versus the placebo interventions. | Weeks 1 and 2 on intervention |
| Colonic Permeability |
| Measure | Description | Time Frame |
|---|---|---|
| Digestive Health | Weekly GI symptoms assessed using the Gastrointestinal Symptom Rating Scale (GSRS). The GSRS consists of 15 questions related to 5 syndromes, constipation, diarrhea, reflux, abdominal pain, and indigestion. Symptoms are scored 1=no discomfort to 7=very severe discomfort. Scores from each of the 15 questions are summed for the total GSRS score. | Weekly through the completion of the 14 week study |
Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Bobbi Langkamp-Henken, PhD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32611-0370 | United States |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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A randomized, double-blind, placebo-controlled crossover in which participants receive one of the study supplements (probiotic or placebo) for a 3-week intervention period each will be used.
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The participants, investigators, and anyone else involved with the study will remain blinded for its entirety.
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| Placebo | Dietary Supplement | The placebo contains ascorbic acid, hypromellose, magnesium stearate, saccharose, potato starch, titanium dioxide and maltodextrin. |
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Difference between the changes (week 2 of intervention with aspirin minus week 1 of intervention without aspirin) in sucralose/erythritol ratio in the 5 to 24-hour urine collection with the probiotic versus the placebo interventions. |
| Weeks 1 and 2 on intervention |
| Whole Gut Permeability | difference in the changes (week 2 of intervention with aspirin minus week 1 of intervention without aspirin) in sucralose/erythritol ratio in the 0 to 24-hour urine collection with the probiotic versus the placebo interventions | Weeks 1 and 2 on each intervention |
| D019602 |
| Food and Beverages |