Ulcerative Colitis Clinical Trial
— RESTORE-UCOfficial title:
Fecal Microbiota Transplantation in Patients With Active Ulcerative Colitis: Restoration of the Microbiome Through Superdonor Selection
The AIM of this study is to investigate whether the FMT success rate in active UC patients
can be increased by intensive donor pre-screening, anaerobic preparation of the FMT and by
repeated FMT.
The investigators will start a national multi-centre double-blind randomized sham-controlled
trial in April 2017 at 6 hospitals in Belgium and 2 in The Netherlands. They will randomly
allocate 108 patients with active ulcerative colitis (Mayo score 4-10, endoscopic Mayo score
2 or 3) in a 1:1 ratio, using a pre-established randomization list, to either 'superdonor'
faecal microbiota transplantation or autologous fecal microbiota transplantation (=sham).
Each patient will receive 4 FMT's. At baseline FMT will be performed during sigmoidoscopy. At
week 1, 2 and 3, the FMT will be administered through rectal instillation. Each FMT will be
derived from one donor. Donors will be pre-selected based on a species richness and abundance
of taxa of interest. The primary outcome will be steroid-free clinical and endoscopic
remission at week 8 (Mayo score ≤2, all subscores ≤ 1, and ≥1 point reduction in endoscopy
subscore). Fecal, blood and mucosal samples and questionnaires will be collected at different
time points. 16S rRNA stool analysis will be performed to assess the microbial changes after
FMT.
Status | Recruiting |
Enrollment | 108 |
Est. completion date | April 30, 2019 |
Est. primary completion date | April 30, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Age >18 years - Patients with currently mild-moderate active ulcerative colitis (defined by endoscopic Mayo sub score 2-3 and a Total Mayo score between 4-10) - Provide written informed consent to participate as shown by a signature on the consent form. - Patients on concomitant UC-therapy are allowed if the concomitant treatment is restricted to current treatment and at a stable dose (not in the induction faze). - Topical therapy and trial medication is not allowed. - A maximum dose of 15mg methylprednisolone. - Negative coproculture (Salmonella, Shigella, Yersinia, Campylobacter, Entamoeba histoliytica, Clostridium difficile toxins and enteropathogenic E. coli) - Women need to use reliable contraceptives during participation in the study Exclusion Criteria: - Consent not obtained or unable to give informed consent - Condition leading to profound immunosuppression - For example: HIV, infectious diseases leading to immunosuppression, bone marrow malignancies, liver cirrhosis - Use of systemic chemotherapy - Use of antibiotics in the previous 4 weeks - Surgery: Total colectomy, presence of a stoma or ileo-anal pouch - Presence of an intra-abdominal fistula - Colon carcinoma - Diverticulitis - Patients who are steroid dependent and requiring >15mg methyl prednisone 2 week before START. - Detection of a gastrointestinal pathogen on stool analysis - A diagnosis of Crohn's disease of indeterminate colitis - Females who are pregnant or actively trying to fall pregnant |
Country | Name | City | State |
---|---|---|---|
Belgium | UZ Leuven | Leuven | Vlaams Brabant |
Lead Sponsor | Collaborator |
---|---|
Universitaire Ziekenhuizen Leuven | Fund for Scientific Research, Flanders, Belgium |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | steroid-free clinical remission | defined as a total Mayo score of 2 or less and with all Mayo subscores of 1 or less. | Week 8 | |
Primary | steroid-free endoscopic remission or response | defined as at least a 1 point reduction from baseline in the endoscopy subscore. | Week 8 | |
Secondary | the investigation of changes in blood and fecal inflammatory markers before and after FMT | changes in calprotectin and C-reactive protein (CRP) | Week 8 | |
Secondary | Steroid-free clinical remission | combined Mayo subscores of 1 or less for rectal bleeding plus stool frequency | Week 8 | |
Secondary | Steroid-free clinical response | a decrease of 3 points or more on the Mayo score, a 50% or greater reduction from baseline in combined rectal bleeding plus stool frequency Mayo subscores, or both. | Week 8 | |
Secondary | Steroid-free endoscopic response | Mayo endoscopic subscore of 1 or less, with a reduction of at least 1 point from baseline | Week 8 | |
Secondary | Steroid-free endoscopic remission | Mayo endoscopy subscore of 0 or 1. | Week 8 |
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