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Randomized, Double-Blind, Placebo-Controlled, Single-Center Clinical Study, where participants will take the Daily Supplement, and record Daily Symptoms, two clinical visits where Hydrogen and Methane Breath Test (HMBT) will be conducted, Abdominal Circumference Measurement will be taken, and two Self Reported Validated Questionnaires: Visual Analogue Scale (VAS) and the Quality of Life Questionnaires.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Oral dietary supplement. Instructions: Take 1 capsule with water as needed, up to 3 capsules per day. Do not take more than 3. |
|
| Dietary Supplement with actives | Active Comparator | Oral dietary supplement. Instructions: Take 1 capsule with water as needed, up to 3 capsules per day. Do not take more than 3. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Dietary Supplement | Placebo |
| |
| Dietary Supplement with actives |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the impact of BTB on hydrogen and methane production in healthy adults | Participants will take the Hydrogen and Methane Breath Test (HMBT) at baseline and after the study at Week4. | From time of enrollement to end of study at Week4 |
| Measure | Description | Time Frame |
|---|---|---|
| To estimate the changes in abdominal circumference as an indicator of distention | Standardized tape measurement at the level of the iliac crest or on top of belly button will be used to evaluate changes in abdominal distention at baseline and after the study at Week4. | From time of enrollement to end of study at Week4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MusB Research | New Port Richey | Florida | 34653 | United States |
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| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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| Dietary Supplement |
Dietary Supplement containing blend of Digestive Enzymes, Dandelion, Ginger & Fennel Extracts |
|
| To assess the changes in validated subjective questionnaire (VAS) for bloating, abdominal pain, distension, and flatulence. |
Participants will take Visual Analogue Scale (VAS) which is a self-reported assessment of bloating and distention severity using PROMIS's GI gas and bloating questionnaire at baseline and after the study at Week4. |
| From time of enrollement to end of study at Week4 |