We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

FMT for Remission of Active Ulcerative Colitis in Adults

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: NCT04202211
Recruitment Status : Not yet recruiting
First Posted : December 17, 2019
Last Update Posted : December 18, 2019
Sponsor:
Collaborators:
Crohn's and Colitis Canada
Vancouver Island Health Authority
Information provided by (Responsible Party):
Theodore Steiner, University of British Columbia

Brief Summary:

The goal of this study is to establish the safety and effectiveness of lyophilized (LYO) fecal microbiota transplant (FMT) for treating ulcerative colitis (UC) in adults. This is multi-site, randomized double-blind, placebo-controlled trial. UC patients with active disease will be recruited at three Canadian centres and the study involves 3 treatment arms:

  1. FMT oral capsules + placebo enema
  2. placebo oral capsules + placebo enema
  3. FMT oral capsules and FMT enema The primary outcome is achievement of remission of UC; the efficacy of LYO-FMT in achieving remission of active ulcerative colitis in adults will be evaluated.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Inflammatory Bowel Diseases Biological: FMT oral Biological: FMT enema Other: Placebo oral Other: Placebo enema Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 145 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 145 active UC participants will be randomized to one of the three treatment groups in 1:2:2 randomization ratio
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Gastroenterologists performing flexible sigmoidoscopes will remain blinded to participant's treatment. One unblinded nurse will administer the FMT enema.
Primary Purpose: Treatment
Official Title: A Randomized Double-blind, Placebo-controlled Trial of Lyophilized Fecal Microbiota Transplantation for the Induction of Remission in Adults With Active Ulcerative Colitis
Estimated Study Start Date : February 2020
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : February 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo oral & enema
twice weekly x 8 weeks: 10 placebo oral capsules + placebo enema
Other: Placebo oral
placebo given orally (10 capsules) twice weekly for total of 8 weeks

Other: Placebo enema
placebo given via enema (1) twice weekly for total of 8 weeks

Active Comparator: LYO-FMT oral + placebo enema
twice weekly x 8 weeks: 10 LYO-FMT oral capsules + 1 placebo enema
Biological: FMT oral
lyophilized FMT given orally (10 capsules) twice weekly for total of 8 weeks

Other: Placebo enema
placebo given via enema (1) twice weekly for total of 8 weeks

Active Comparator: LYO-FMT oral + LYO-FMT enema
twice weekly x 8 weeks: 10 LYO-FMT oral capsules + 1 LYO-FMT enema
Biological: FMT oral
lyophilized FMT given orally (10 capsules) twice weekly for total of 8 weeks

Biological: FMT enema
lyophilized FMT given via enema (1) twice weekly for total of 8 weeks




Primary Outcome Measures :
  1. Remission of UC [ Time Frame: 9 weeks following receipt of LYO-FMT ]
    achievement of remission of UC as defined by Mayo score ≤ 2 AND Mayo endoscopic score of ≤ 1


Secondary Outcome Measures :
  1. Incidence/absence of adverse events upon treatment with LYO-FMT [safety and tolerability] [ Time Frame: up to 5 years post-FMT ]
    Safety of LYO-FMT in patients with active UC as determined by absence of adverse events

  2. UC disease progression [ Time Frame: immediately after FMT (study) treatment period up to 5 years post-FMT ]

    Determine progression of UC based on development of any of the following:

    1. Clinical flare of UC requiring hospitalization up to 3 months post-FMT
    2. Increase in dosages of current UC specific medications up to 3 months' post FMT
    3. Time to colectomy for UC flare up to 12 months' post FMT
    4. Time to death directly attributable to UC up to 5 years post FMT
    5. Improvement in clinical response defined by decrease in Partial Mayo score by ≥ 3 points from pre to post LYO-FMT.
    6. Improvement in patient-reported health related QoL using Valuation of Lost Productivity and (VOLP) and RAND VR12 measured at pre and at 5 weeks, 12 and 24 weeks following LYO-FMT and annually for 5 years
    7. Reduction in biologic inflammatory markers (serum c-reactive protein (CRP) and fecal calprotectin) from pre to post LYO-FMT



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:   No
Criteria

Inclusion Criteria:

  • Able to provide informed consent.
  • Willing and able to comply with all the required trial procedures
  • Active ulcerative colitis as defined by Mayo score > 3 AND Mayo endoscopic sub-score > 1 (within 30 days before enrollment, or at baseline)

Exclusion Criteria:

  • Planned or actively taking another investigational product
  • Abdominal surgery within the past 60 days
  • Patients with neutropenia with absolute neutrophil count <0.5 x 109/L at - Evidence of toxic megacolon or gastrointestinal perforation on imaging
  • Peripheral white blood cell count > 35.0 x 109/L at enrollment AND temperature > 38.0oC
  • Active infectious diarrhea at the time of enrolment
  • Increase in medical therapy for UC within 3 months of enrollment. Continued treatment with stable dose of 5-ASA, azathioprine, 6-mercaptopurine, cyclosporine, prednisone and/or anti- TNF agents for at least 3 months of is allowed
  • Severe UC requiring hospitalization at the time of enrolment
  • Pregnant or lactating
  • History of anaphylaxis to any food
  • Requiring oral and/or intravenous systemic antibiotic therapy at the time of study enrolment
  • Unwilling to discontinue probiotic (yogurt is allowed)
  • Severe underlying disease such that the patient is not expected to survive for at least 30 days.
  • Any condition that in the opinion of the investigator that would pose harm to the participant or the research staff for the potential participant to take part in the trial

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): NCT04202211


Contacts
Layout table for location contacts
Contact: Laura Oliveira 604 875 4111 ext 64164 laura.oliveira@ubc.ca

Locations
Layout table for location information
Canada, Alberta
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7
Contact: Rose Franz       Rose.Franz@albertahealthservices.ca   
Principal Investigator: Dina Kao, MD         
Canada, British Columbia
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Laura Oliveira    604 875 4111 ext 64164    laura.oliveira@ubc.ca   
Principal Investigator: Ted Steiner, MD         
Royal Jubilee Hospital
Victoria, British Columbia, Canada, V8R 1J8
Contact: Peyman Goldeh       Peyman.Goldeh@VIHA.CA   
Principal Investigator: Christine Lee, MD         
Sponsors and Collaborators
University of British Columbia
Crohn's and Colitis Canada
Vancouver Island Health Authority
Investigators
Layout table for investigator information
Principal Investigator: Ted Steiner, MD University of British Columbia
Layout table for additonal information
Responsible Party: Theodore Steiner, MD, Professor, University of British Columbia
ClinicalTrials.gov Identifier: NCT04202211    
Other Study ID Numbers: H19-03882
First Posted: December 17, 2019    Key Record Dates
Last Update Posted: December 18, 2019
Last Verified: December 2019
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 Theodore Steiner, University of British Columbia:
ulcerative colitis
Fecal Microbiota transplant
FMT
Inflammatory bowel disease
IBD
Additional relevant MeSH terms:
Layout table for MeSH terms
Colitis
Colitis, Ulcerative
Intestinal Diseases
Inflammatory Bowel Diseases
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Pathologic Processes