The Effects of a Novel Nutritional Product on Nutrient Gaps and Gut Health in Adults With Occasio… (NCT06564285) | Clinical Trial Compass
CompletedNot Applicable
The Effects of a Novel Nutritional Product on Nutrient Gaps and Gut Health in Adults With Occasional Gastrointestinal Issues
United States24 participantsStarted 2024-08-28
Plain-language summary
This study is a randomized, double-blind, placebo-controlled study of N=40 adult men and women with occasional GI issues. This study to assess the effect of a novel dietary supplement on the gut microbiome, nutrient gaps, and tolerability.
Who can participate
Age range
18 Years – 60 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.
To be eligible to participate in this study, an individual must meet all of the following criteria:
* Provide voluntary signed and dated informed consent.
* Does not have any chronic health conditions that could impact participation in this study such as oncological or psychiatric disorders.
* No known history of chronic illness or disease.
* Aged between 18 and 60 years (inclusive).
* Body Mass Index of 20-34.9 (inclusive).
* Agree to maintain existing dietary and physical activity patterns throughout the study period.
* Willing and able to comply with the study protocol.
* Self-reported gastrointestinal symptoms, such as self-reported abdominal pain, gas and bloating after meals, heartburn/acid reflux after meals, and issues with digestion.
* Must be in good general health.
* Following a stable, consistent diet pattern.
* Agree to refrain from any lifestyle changes that may affect their GI tract and IBS symptoms for the duration of the study.
* Not currently taking and not planning on introducing any product, supplement or medication aimed at gut health or nutritional gaps during the study period.
* Resides in the United States.
An individual who meets the following criteria will be excluded from participation in this study:
* Prior prescriptions for IBS or any other medication (OTC and prescription) targeting the gut.
* Taking any supplements targeting the gut in the past 30 days.
* Current IBS treatment (e.g. proton pump inhibitors, laxatives).
* Follow an extreme diet…
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.