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The study was terminated due to insufficient enrollment and recruitment struggles
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| Name | Class |
|---|---|
| University of North Texas, Denton, TX | OTHER |
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The goal of this study is to determine the safety and efficacy of two enzyme cocktails in healthy adults with mild to moderate gastrointestinal discomfort. The main question aims to answer whether a 4-week administration of an enzyme cocktail can improve how the participant feels about their gut health. This is done by completing a weekly questionnaire, and the results are compared between the 4 weeks the participants are on a placebo and the 4 weeks the participants are on the enzyme cocktail. Participants will also provide a stool sample at the start and end of each treatment. Stool samples will collected and stored in case further microbiome analysis is warranted.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Digestive Enzyme Cocktail A | Experimental | Arm receiving investigational product A |
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| Digestive Enzyme Cocktail B | Experimental | Arm receiving investigational product B |
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| Placebo A | Placebo Comparator | Arm receiving placebo A |
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| Placebo B | Placebo Comparator | Arm receiving Placebo B |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enzyme Cocktail A | Dietary Supplement | Enzyme cocktail A in the form of a capsule with a daily dose of 275mg taken 3 times a day for 4 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in the Gastrointestinal Symptoms Rating Scale - Irritable Bowel Syndrome (GSRS-IBS) | Change in GSRS-IBS total score from baseline to end of intervention. Each question is rated on a 7 point Likert scale with higher scores representing more troublesome symptoms. Questionnaire collected weekly from baseline through study completion at the end of week 12. | From baseline to the end of intervention 4 weeks later. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Stool Consistency at end of intervention | Difference in weekly self reported stool consistency, as measured by the Bristol Stool Form Scale (BSFS) on a daily basis. BSFS max score 7 - lower scores indicate constipation, higher scores indicate diarrhea. | Through study completion, an expected average of 70 days |
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Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of North Texas | Denton | Texas | 76201 | United States |
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| Enzyme Cocktail B | Dietary Supplement | Enzyme cocktail B in the form of a capsule with a daily dose of 50mg taken 3 times a day for 4 weeks. |
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| Placebo A | Dietary Supplement | Placebo A matching investigational product A given 3 times a day for 4 weeks. |
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| Placebo B | Dietary Supplement | Placebo B matching investigational product B given 3 times a day for 4 weeks. |
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| Change from baseline in the Stool Frequency at end of intervention |
Change in weekly average stool frequency throughout the period between baseline and end of intervention. |
| Through study completion, an expected average of 70 days |
| Change in Microbiome (faecal samples) | Change in stool microbiome between baseline and end of intervention for each of cross over runs (Change between day 0 and day 28, change between day 42 and 70) | Day 0 and Day 28; Day 42 and Day 70 |
| Body Mass Index (BMI) | Participants whole-body weight [kg] and height [m] will be measured and BMI will be calculated as kg/m^2 | Day 0, Day 28, Day 42, and Day 70 |
| Total Fat Mass | Participants total fat mass (kg) will be tested using a BIA scale. | Day 0, Day 28, Day 42, and Day 70 |
| Food Intake | Food intake is measured by the NHANES Food Frequency Questionnaire (NHANES-FFQ), which collects data to measure habitual food intake at baseline. | Day 0 |
| Positive and Negative Affect Schedule (PANAS-SF) | The PANAS-SF is a self-report questionnaire that consists of two 10-item scales to measure both positive and negative affect. Each item is rated on a 5-point scale of 1 (not at all) to 5 (very much). | Day 0, Day 28, Day 42, and Day 70 |