A Study to Evaluate the Effects of a Fiber Supplement on Gut Health (NCT07755735) | Clinical Trial Compass
CompletedNot Applicable
A Study to Evaluate the Effects of a Fiber Supplement on Gut Health
United States50 participantsStarted 2025-08-26
Plain-language summary
This is a randomized, triple-blind, placebo-controlled clinical trial evaluating the effects of BelliWelli Daily Fiber + Probiotics supplement on gut health over 12 weeks. One hundred participants with self-reported gut health issues will be randomized to receive either the active fiber supplement or a matched placebo product, taken twice daily.
Participants will complete questionnaires and provide waist and body composition measurements at Baseline, Week 4, Week 8, and Week 12. The primary outcomes include changes in overall gut health scores, waist circumference, and body composition. Secondary outcomes include participant-perceived effects on bloating, regularity, hydration, energy, and hair, skin, and nail support.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Be male or female
* Be aged 18 or older
* Experiencing issues regarding all of the following over the past 4 weeks: bloating, irregular bowel movements, and self-perceived poor gut health
* Generally healthy - does not live with any uncontrolled chronic disease
* Willing to discontinue any other supplements or herbal remedies that target gut or digestive health
* Not planning on introducing any products or any new forms of prescription medication or supplements that target gut health for the study duration
* Willing to maintain current diet, sleep pattern, and activity levels for the duration
* Resides in the United States
* Not currently partaking in another research study and will not be partaking in any other research study for the next 12 weeks and at any point during this study's duration
Exclusion Criteria:
* Anyone with pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders
* Anyone with a known history of severe digestive disorders like acid reflux, Irritable Bowel Syndrome (IBS), Irritable Bowel Disease (IBD), Crohn's disease, or gastrointestinal tract surgeries
* Anyone with any allergies or sensitivities to any of the study product ingredients
* Any women who are pregnant, breastfeeding, or trying to conceive (or who will be at any point during the study period)
* Anyone who is vegan and/or does not consume animal products for any reasons
* Anyone unwill…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.