Transfer of Feces in Ulcerative Colitis 2 (NCT05998213) | Clinical Trial Compass
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 range18 Years – 70 Years
SexALL
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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…
What they're measuring
1
Clinical and endoscopic remission
Timeframe: week 8
Trial details
NCT IDNCT05998213
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)