Impact of Fecal Microbiota Transplantation in Ulcerative Colitis (NCT03483246) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Impact of Fecal Microbiota Transplantation in Ulcerative Colitis
France150 participantsStarted 2018-09-17
Plain-language summary
Ulcerative colitis (UC) is a chronic relapsing inflammatory bowel disease. UC pathogenesis remains poorly understood but involves an inappropriate immune response toward an unbalanced gut microbiota (called dysbiosis) in predisposed hosts.
The purpose of this study is to determine the effect of the fecal microbiota transplantation on UC.
Who can participate
Age range
18 Years – 74 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:
Inclusion Criteria for patients :
* Age ≥ 18 years and \< 75 years
* Ulcerative colitis (according to the Lennard Jones criteria) diagnosed for at least 3 months and :
* Currently active (PMC \> 1) and planned to be treated by systemic corticosteroids (minimum 40mg prednisone equivalent daily) Or
* Currently treated by systemic corticosteroid (minimum 40 mg prednisone equivalent daily) within max 3 weeks Or
* Steroid dependent patients (at least one unsuccessful attempt to discontinue steroid within the last 6 months before inclusion)
* Patient with health insurance (AME excepted)
* Informed written consent
* Female of child-bearing age with an active contraception and this during at least period of treatment until the end of active follow-up period (week 24)
Inclusion Criteria for healthy volunteers donors :
* Age ≥ 18 years and \< 50 years
* 17 kg/m² \< body mass index \< 30 kg/m²
* Regular bowel movement defined as at least 1 stool every other day and maximum 2 stools per day
* Subject with health insurance (AME excepted)
* Informed Written consent
Exclusion Criteria:
Exclusion Criteria for patients :
* UC complication requiring surgical treatment
* Patient treated with high dose corticosteroid more than three weeks before inclusion (≥ 40 mg prednisone equivalent daily) except in case of steroid-dependence
* Contraindication to colonoscopy or anesthesia
* Pregnancy or breastfeeding during the study
* Treatment preceding the colonoscopy wit…
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
Steroid-free clinical and endoscopic remission
Timeframe: 12 weeks after FMT or sham-transplantation