Effects of a Mushroom Blend on Gastrointestinal Symptoms and the Microbiome (NCT07027462) | Clinical Trial Compass
CompletedNot Applicable
Effects of a Mushroom Blend on Gastrointestinal Symptoms and the Microbiome
United States40 participantsStarted 2025-06-16
Plain-language summary
This study will investigate the efficacy of a mushroom blend to improve gastrointestinal symptoms and mood. It will also be determining if the mushroom blend has an effect on the gut microbiome and metabolomics.
Who can participate
Age range
30 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.
Inclusion Criteria:
* Healthy males and females aged 30 to 60 years of age (inclusive).
* Subject has provided written and dated informed consent.
* Individual indicates they experience occasional GI discomfort, and have never been diagnosed with any gastrointestinal disorder, yet have occasional complaints of bowel irregularity, bloating or discomfort (after meals or beverages).
* Subject may express that they experience occasional after-snack or a meal, intestinal gas-related symptoms including abdominal discomfort, cramps, distended feeling/bloating, and or flatulence as part of the study entry criteria.
* Occasional GI distress will be defined as \< 3 times per week over the prior 6 weeks, with each episode resolving within 24 hours and not requiring medical intervention.
* Body Mass Index (BMI) 19 to 34.9 kg/m2 (normal weight to class I obesity)
* Subject is a non-smoker.
* Subject agrees to not use any new vitamin, mineral, or other dietary supplement product until after study completion.
* Subject agrees to provide a stool sample for microbiota analysis per the study protocol.
* Subject is willing and able to comply with the protocol and the scheduled study visits.
* Subject will be asked about dietary supplementation use within the past 6 months.
* If subject began taking a supplement within the past month, participant will be asked to discontinue supplement use followed by a 2-week washout prior to participation.
* In all other cases, supplement use will be ask…
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.
What they're measuring
1
Changes in the gastrointestinal symptoms rating scale.