UC Cohort - The Influence of Diet on Gut Microbiotas (NCT04933162) | Clinical Trial Compass
CompletedNot Applicable
UC Cohort - The Influence of Diet on Gut Microbiotas
United States6 participantsStarted 2021-08-03
Plain-language summary
The purpose of this research is to determine if different diets have different effects on the inflammation in the colon.
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
. Adults ≥ 18 years old
. Ability to give informed consent
. Diagnosis of ulcerative colitis
. Moderate UC disease activity defined by a Mayo Score of \>6 with endoscopic score of 2
. On a baseline diet characterized by:
Exclusion criteria
. Prior history of gastrointestinal surgeries (except appendectomy and cholecystectomy)
. Use of tobacco products within the past 6 months (since nicotine may affect intestinal permeability)
. Use of NSAIDs or aspirin and unable or unwilling to stop taking two weeks prior to permeability test and for the duration of the study
. Use of osmotic laxatives and unable or unwilling to stop taking one week prior to permeability test and for the duration of the study
. Use of oral corticosteroids and unable or unwilling to stop use of oral corticosteroids within the previous 2 weeks and for the duration of the study
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
Decrease in endoscopic Mayo score for ulcerative colitis inflammation
Timeframe: 8 weeks
2
Clinical remission derived from patient reported outcomes
. Multiple dietary restrictions or unable/unwilling to alter dietary protein or dietary fiber.
. Unwilling to stop ingestion of alcohol and artificial sweeteners such as Splenda™ (sucralose), Nutrasweet™ (aspartame), sorbitol, xylitol, lactulose, or mannitol 2 days before and during the permeability testing days, e.g. foods to be avoided are sugarless gums or mints and diet beverages
. Unwilling to stop stenuous exercise (running \>5 miles or equivalent) one week prior to the permeability tests