A Randomized, Placebo Controlled Clinical Study to Assess the Effect of a Blend of Digestive Enzymes and Extracts on Bloating in Adults.
Part of paid clinical trials in New Port Richey, Florida.
- Sponsor
- Olly, PBC
- Study ID
- NCT07033000
- Status
- Not Yet Recruiting
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Conditions
- Healthy
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 65 Years
- Healthy Volunteers
- Accepted
Interventions
- Placebo — DIETARY_SUPPLEMENTPlacebo
- Dietary Supplement with actives — DIETARY_SUPPLEMENTDietary Supplement containing blend of Digestive Enzymes, Dandelion, Ginger \& Fennel Extracts
Study Details
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.
Key Dates
- Start date
- Jul 14, 2025
- Status verified
- Jun 2025
- Primary completion
- Aug 25, 2025
- Completion
- Sep 15, 2025
Study Design
- Enrollment
- 50 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- SUPPORTIVE_CARE
Arms
- Placebo Comparator: PlaceboOral dietary supplement. Instructions: Take 1 capsule with water as needed, up to 3 capsules per day. Do not take more than 3.
- Active Comparator: Dietary Supplement with activesOral dietary supplement. Instructions: Take 1 capsule with water as needed, up to 3 capsules per day. Do not take more than 3.
Primary Outcome Measure
To determine the impact of BTB on hydrogen and methane production in healthy adults [ Time Frame: From time of enrollement to end of study at Week4 ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| MusB Research | New Port Richey | Florida | 34653 |
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