Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
100 participants
INTERVENTIONAL
2024-12-15
2025-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
TRIPLE
Study Groups
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Digestive Enzyme Cocktail A
Arm receiving investigational product A
Enzyme Cocktail A
Enzyme cocktail A in the form of a capsule with a daily dose of 275mg taken 3 times a day for 4 weeks.
Digestive Enzyme Cocktail B
Arm receiving investigational product B
Enzyme Cocktail B
Enzyme cocktail B in the form of a capsule with a daily dose of 50mg taken 3 times a day for 4 weeks.
Placebo A
Arm receiving placebo A
Placebo A
Placebo A matching investigational product A given 3 times a day for 4 weeks.
Placebo B
Arm receiving Placebo B
Placebo B
Placebo B matching investigational product B given 3 times a day for 4 weeks.
Interventions
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Enzyme Cocktail A
Enzyme cocktail A in the form of a capsule with a daily dose of 275mg taken 3 times a day for 4 weeks.
Enzyme Cocktail B
Enzyme cocktail B in the form of a capsule with a daily dose of 50mg taken 3 times a day for 4 weeks.
Placebo A
Placebo A matching investigational product A given 3 times a day for 4 weeks.
Placebo B
Placebo B matching investigational product B given 3 times a day for 4 weeks.
Eligibility Criteria
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Exclusion Criteria
* Having taken oral antibiotics in the previous 3-months or if they start antibiotics during the study
* Currently or having taken a prebiotic, probiotic, or digestive enzyme supplement in the previous 3-months
* Currently consuming 1 or more servings of fermented foods or yogurt on a daily basis
* Doctor diagnosed chronic disease (i.e. Diabetes, Cardiovascular, etc.)
* Doctor diagnosed immunodeficiency
* Current use of doctor prescribed immunosuppressive agents (corticosteroids, methotrexate, etc.)
* Pregnancy, 6 months postpartum period, or current breastfeeding
* Women of childbearing age planning pregnancy during the course of the study
18 Years
65 Years
ALL
Yes
Sponsors
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University of North Texas, Denton, TX
OTHER
The Archer-Daniels-Midland Company
INDUSTRY
Responsible Party
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Locations
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The University of North Texas
Denton, Texas, United States
Countries
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Central Contacts
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Other Identifiers
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CTB2022TN225D
Identifier Type: -
Identifier Source: org_study_id