Restoration of the Microbiome Through Superdonor Selection (RESTORE-UC)
|ClinicalTrials.gov Identifier: NCT03110289|
Recruitment Status : Unknown
Verified March 2018 by Clara Caenepeel, Universitaire Ziekenhuizen Leuven.
Recruitment status was: Recruiting
First Posted : April 12, 2017
Last Update Posted : March 30, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Ulcerative Colitis||Other: superdonor FMT Other: autologous FMT||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||108 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||We 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)|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Fecal Microbiota Transplantation in Patients With Active Ulcerative Colitis: Restoration of the Microbiome Through Superdonor Selection|
|Actual Study Start Date :||April 30, 2017|
|Estimated Primary Completion Date :||April 30, 2019|
|Estimated Study Completion Date :||April 30, 2019|
Experimental: Superdonor FMT
Fecal microbiota transplantation from a healthy donor that was selected based on a fecal/blood screening, medical interview and on abundance of taxa of the investigators their interest
Other: superdonor FMT
Fecal microbiota transplantation (FMT) is the transfer of feces from a healthy "superdonor" to the patient.
Sham Comparator: Autologous FMT
Fecal microbiota transplantation derived from feces from the patient her/himself.
Other: autologous FMT
Fecal microbiota transplantation (FMT) with feces from the patient him/herself
- steroid-free clinical remission [ Time Frame: Week 8 ]defined as a total Mayo score of 2 or less and with all Mayo subscores of 1 or less.
- steroid-free endoscopic remission or response [ Time Frame: Week 8 ]defined as at least a 1 point reduction from baseline in the endoscopy subscore.
- the investigation of changes in blood and fecal inflammatory markers before and after FMT [ Time Frame: Week 8 ]changes in calprotectin and C-reactive protein (CRP)
- Steroid-free clinical remission [ Time Frame: Week 8 ]combined Mayo subscores of 1 or less for rectal bleeding plus stool frequency
- Steroid-free clinical response [ Time Frame: Week 8 ]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.
- Steroid-free endoscopic response [ Time Frame: Week 8 ]Mayo endoscopic subscore of 1 or less, with a reduction of at least 1 point from baseline
- Steroid-free endoscopic remission [ Time Frame: Week 8 ]Mayo endoscopy subscore of 0 or 1.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03110289
|Contact: Clara Caenepeel, MD||+32 16 32 51 email@example.com|
|Contact: Jolien Lefrère||+32 16 34 88 firstname.lastname@example.org|
|Leuven, Vlaams Brabant, Belgium, 3010|
|Contact: Clara Caenepeel, MD|
|Principal Investigator:||Séverine Vermeire, MD and PhD||UZ Leuven|