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This study was a prospective randomized clinical study. There was interventional treatment for a total of 8 weeks including a 2-week washout period. The subjects attended four appointments in the clinic throughout the duration of the study.
Study Primary Objective:
• To assess improvement in bloating symptoms
Study Secondary Objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Oral dietary supplement. Instructions: Subjects were instructed to take the product (1 pill) with a glass of water in the morning. |
|
| Dietary Supplement with Active Ingredient Blend | Active Comparator | Oral dietary supplement. Instructions: Subjects were instructed to take the product (1 pill) with a glass of water in the morning. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Dietary Supplement | Eligible subjects will receive Placebo to take daily for six weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Digestive Quality of Life Questionnaire (DQLQ) scores | To assess changes in scores related to bloating, diarrhea, constipation and heartburn on quality-of-life indicators, comparing active supplement to placebo group | from enrollment to end of study at 8 weeks |
| Changes in Symptom Severity Score (Diary) | Patients filled out the symptoms diary that had questionnaires of bowel habits. Abdominal pain and bloating were rated on a 100-point visual analogue scale with 0=none and 100=severe, comparing active supplement to placebo group | from enrollment to end of study at 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Gastrointestinal Short Form Questionnaire (GSFQ) Scores | To assess changes in gastrointestinal symptoms comparing active supplement to placebo group | from enrollment to end of study at 8 weeks |
| Changes in Stool Consistency (Bristol Stool Scale) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| See Final Report | San Francisco | California | 94127 | 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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double-blind
| Dietary Supplement with Active Ingredient Blend |
| Dietary Supplement |
Eligible subjects will receive Active supplement to take daily for six weeks |
|
Daily stool consistency ratings will provide data on changes in bowel health and regularity. Average stool consistency scores will be compared across baseline, active treatment, and placebo phases. |
| from enrollment to end of study at 8 weeks |