CompletedPhase 2

Transfer of Feces in Ulcerative Colitis 2

Netherlands85 participantsStarted 2020-06-12

Plain-language summary

The goal of this placebo-controlled randomised multicenter trial is to evaluate the efficacy and safety of anaerobic prepared donor fecal microbiota transplantation (FMT) compared to autologous FMT in patient with ulcerative colitis. Participants will receive 4 treatments with frozen FMT via both upper and lower gastro-intestinal route (infusion via duodenal tube and enemas). Donors are selected based on microbiota profile.

Who can participate

Age range

18 Years – 70 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: * Age ≥18 and \<70 * Ability to give informed consent * Established ulcerative colitis with known involvement of the left colon according to the Lennard-Jones criteria * Partial mayo score of ≥ 3 and calprotectin \> 250 * Full Mayo score 5-9 * Endoscopic Mayo score of ≥2 in either the rectum or sigmoid upon screening sigmoidoscopy * Stable dose of thiopurines or , 5-ASA, or budesonide in preceding 8 weeks. * Stable dose of budesonide in preceding 2 weeks. * Prednisone use ≤15mg/day in preceding 2 weeks with a mandatory taper of 5 mg per week starting from week 4. * Women need to use reliable contraceptives during participation in the study * Alkaline phosphatase \> 1.5 x ULN in the subgroup of PSC/UC patients. Exclusion Criteria: * Condition leading to profound immunosuppression * For example: HIV, infectious diseases leading to immunosuppression, bone marrow malignancies * Use of systemic chemotherapy * Child-Pugh B liver cirrhosis * Anti-TNFα treatment in preceding 2 months * Vedolizumab treatment in preceding 2 months * Tofacitinib treatment in preceding 2 months * Ustekinumab treatment in preceding 2 months * Cyclosporine treatment in preceding 4 weeks * Use of Methotrexate in preceding 2 months * Prednisolone dose \> 15 mg/day in preceding 2 weeks * Use of topical therapy in preceding 2 weeks * Life expectancy \< 12 months * Difficulty with swallowing * Use of systemic antibiotics in preceding 4 weeks * Use of probiotic treatment in precedin…

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

Clinical and endoscopic remission

Timeframe: week 8

Trial details

NCT IDNCT05998213

SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-01-10

View on ClinicalTrials.gov More Ulcerative Colitis trials