Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Restoration of the Microbiome Through Superdonor Selection (RESTORE-UC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03110289
Recruitment Status : Recruiting
First Posted : April 12, 2017
Last Update Posted : March 30, 2018
Sponsor:
Collaborator:
Fund for Scientific Research, Flanders, Belgium
Information provided by (Responsible Party):
Clara Caenepeel, Universitaire Ziekenhuizen Leuven

Brief Summary:

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

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Randomized
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)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.

  2. steroid-free endoscopic remission or response [ Time Frame: Week 8 ]
    defined as at least a 1 point reduction from baseline in the endoscopy subscore.


Secondary Outcome Measures :
  1. 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)

  2. Steroid-free clinical remission [ Time Frame: Week 8 ]
    combined Mayo subscores of 1 or less for rectal bleeding plus stool frequency

  3. 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.

  4. 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

  5. Steroid-free endoscopic remission [ Time Frame: Week 8 ]
    Mayo endoscopy subscore of 0 or 1.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03110289


Contacts
Layout table for location contacts
Contact: Clara Caenepeel, MD +32 16 32 51 48 clara.caenepeel@kuleuven.be
Contact: Jolien Lefrère +32 16 34 88 56 jolien.lefrere@uzleuven.be

Locations
Layout table for location information
Belgium
UZ Leuven Recruiting
Leuven, Vlaams Brabant, Belgium, 3010
Contact: Clara Caenepeel, MD         
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Fund for Scientific Research, Flanders, Belgium
Investigators
Layout table for investigator information
Principal Investigator: Séverine Vermeire, MD and PhD UZ Leuven

Layout table for additonal information
Responsible Party: Clara Caenepeel, PhD-student under supervision of Prof. Dr. Séverine Vermeire, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT03110289     History of Changes
Other Study ID Numbers: S59525
First Posted: April 12, 2017    Key Record Dates
Last Update Posted: March 30, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Clara Caenepeel, Universitaire Ziekenhuizen Leuven:
Fecal microbiota transplantation
Additional relevant MeSH terms:
Layout table for MeSH terms
Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases