Role of Diet on the Microbiome of the Digestive System (NCT04666727) | Clinical Trial Compass
RecruitingNot Applicable
Role of Diet on the Microbiome of the Digestive System
United States30 participantsStarted 2020-09-29
Plain-language summary
This study is to learn more about how diet affects the microbiome (bacteria and microorganisms) of the digestive system. Researchers want to learn if this, in turn, has an effect on if and how people then develop colorectal cancer.
Who can participate
Age range
45 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:
* GROUP I: Patients presenting for a screening colonoscopy
* GROUP I: Age of 45 and above
* GROUP I: Strict vegetarian diet, determined by using diet history questionnaire 3.0 National Institutes of Health (NIH)
* GROUP I: Non smoker
* GROUP I: Ability to understand and willingness to sign an informed consent form, complete web based dietary assessment and provide stool, colonic mucosa and blood samples
* GROUP II: Patients presenting for a screening colonoscopy
* GROUP II: Age of 45 and above
* GROUP II: Omnivorous diet
* GROUP II: Non smoker
* GROUP II: Ability to understand and willingness to sign an informed consent form, complete web based dietary assessment and provide stool, colonic mucosa and blood sample
Exclusion Criteria:
* • Current smokers (nicotine abuse only)
* Positive family history of colon cancer or colon cancer related syndromes
* Recent use of antibiotics in 1 month
* History of inflammatory bowel disease, and/or radiation enteritis or colitis
* Pregnant and breastfeeding women
* Women of child-bearing potential who have positive urine or serum pregnancy test
* Heavy drinker (defined as more than 14 drinks per week)
* Currently using anti-flatulence medications, probiotics and/or fiber supplements
* Major dietary restrictions and/or following a special diet
* Patient with positive fecal test/symptoms
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.