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| Name | Class |
|---|---|
| The National Institute of Probiotics | OTHER |
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Clinical trial to compare safety and effectiveness of 10-week supplementation with Trenev Trio®/Healthy Trinity® vs. placebo in otherwise healthy subjects with recurrent gastrointestinal symptoms.
This study is a double-blind, randomized, placebo-controlled, parallel group trial comparing the safety and effectiveness of supplementation with Trenev Trio®/Healthy Trinity® vs. placebo in otherwise healthy subjects with recurrent gastrointestinal symptoms. Subjects will be recruited and, following successful completion of a 2-week run-in period, will be randomized to Trenev Trio®/Healthy Trinity® or placebo and will consume their assigned study product daily for 10 weeks. The study endpoints of this trial include relief of overall gastrointestinal symptoms, acid indigestion, abdominal cramping, constipation, diarrhea, gas, and bloating as well as product safety over the 10-week supplementation period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo capsule | Placebo Comparator | 40 subjects allocated to daily placebo capsule for 10 weeks |
|
| Trenev Trio®/Healthy Trinity® | Experimental | 80 subjects allocated to Trenev Trio®/Healthy Trinity® for 10 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trenev Trio®/Healthy Trinity® | Dietary Supplement | Trenev Trio®/Healthy Trinity® (1 capsule, 2x/day for 10 weeks), which offers a daily dose of: a) Lactobacillus acidophilus NAS strain (10 billion CFU), b) Bifidobacterium bifidum Malyoth strain (40 billion CFU), and c) Lactobacillus delbrueckii subspecies bulgaricus LB-51 strain (10 billion CFU) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean total Gastrointestinal Symptom Rating Scale (GSRS) score | 10 weeks | |
| Gastrointestinal Quality of Life Index (GIQLI) total score | 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Gastrointestinal Symptom Rating Scale subscores | 10 weeks | |
| Gas severity | 10 weeks | |
| Bloating severity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Duane Wombolt, MD | Clinical Research Associates of Tidewater | Principal Investigator |
| Jeffrey Stewart, MD | Research Across America | Principal Investigator |
| Michael Sinitsa, MD | Research Across America | Principal Investigator |
| Helen Stacey, MD | Diablo Clinical Research | Principal Investigator |
| Lydie Hazan, MD | Axis Clinical Trials | Principal Investigator |
| JoAnn Hattner, MPH, RD | Sprim ALS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Axis Clinical Trials | Los Angeles | California | 90036 | United States | ||
| Sprim ALS |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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|
|
| Placebo | Dietary Supplement | Daily placebo for 10 weeks |
|
|
| 10 weeks |
| Acid indigestion severity | 10 weeks |
| Abdominal cramping severity | 10 weeks |
| Stool consistency (measured with Bristol Stool Form Scale) | 10 weeks |
| Stool frequency | 10 weeks |
| Concomitant medication use | 10 weeks |
| Adverse event frequency | 10 weeks |
| Adverse event severity | 10 weeks |
| San Francisco |
| California |
| 94109 |
| United States |
| Research Across America | West Lawn | Pennsylvania | 19609 | United States |
| Research Across America | Carrollton | Texas | 75010 | United States |
| Clinical Research Associates of Tidewater | Norfolk | Virginia | 23507 | United States |
| D019602 |
| Food and Beverages |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |