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Primary Objective:
• To confirm the efficacy of the probiotic product Healthy Trinity (retail label)/Trenev Trio (professional label) in the improvement of symptoms in adult patients with diarrhea-predominant irritable bowel syndrome (IBS-D) and functional dyspepsia
Secondary Objective:
• To confirm the safety of the probiotic product Healthy Trinity (retail label)/Trenev Trio (professional label) in adult patients with IBS-D and functional dyspepsia
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic | Dietary Supplement | 2 capsules, 3x/day capsules of Healthy Trinity (retail label)/Trenev Trio (professional label), for a total daily dose of:
|
| Measure | Description | Time Frame |
|---|---|---|
| Abdominal pain severity | 8 weeks | |
| Stool consistency (Bristol Stool Chart) | 8 weeks | |
| Dyspepsia Symptom Severity Index (DSSI) | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with 1 or more adverse events | 8 weeks |
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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 |
| David Wyatt, MD | In-Quest Medical Research, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| In-Quest Medical Research, LLC | Duluth | Georgia | 30096 | United States | ||
| Clinical Research Associates of Tidewater |
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| ID | Term |
|---|---|
| D003967 | Diarrhea |
| D004415 | Dyspepsia |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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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|
| Placebo | Dietary Supplement | 2 capsules, 3x/day placebo capsules |
|
| Norfolk |
| Virginia |
| 23507 |
| United States |
| D019602 |
| Food and Beverages |