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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

Tracking Information
First Submitted Date  ICMJE December 13, 2019
First Posted Date  ICMJE December 17, 2019
Last Update Posted Date December 18, 2019
Estimated Study Start Date  ICMJE February 2020
Estimated Primary Completion Date May 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 13, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 16, 2019)
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: December 13, 2019)
  • safety of LYO-FMT [ Time Frame: up to 5 years post-FMT ]
    Safety of LYO-FMT in patients with active UC as determined by absence of adverse events
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE FMT for Remission of Active Ulcerative Colitis in Adults
Official Title  ICMJE A Randomized Double-blind, Placebo-controlled Trial of Lyophilized Fecal Microbiota Transplantation for the Induction of Remission in Adults With Active Ulcerative Colitis
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE
  • Ulcerative Colitis
  • Inflammatory Bowel Diseases
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Placebo Comparator: Placebo oral & enema
    twice weekly x 8 weeks: 10 placebo oral capsules + placebo enema
    Interventions:
    • Other: Placebo oral
    • Other: Placebo enema
  • Active Comparator: LYO-FMT oral + placebo enema
    twice weekly x 8 weeks: 10 LYO-FMT oral capsules + 1 placebo enema
    Interventions:
    • Biological: FMT oral
    • Other: Placebo enema
  • Active Comparator: LYO-FMT oral + LYO-FMT enema
    twice weekly x 8 weeks: 10 LYO-FMT oral capsules + 1 LYO-FMT enema
    Interventions:
    • Biological: FMT oral
    • Biological: FMT enema
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: December 13, 2019)
145
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2025
Estimated Primary Completion Date May 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Laura Oliveira 604 875 4111 ext 64164 laura.oliveira@ubc.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04202211
Other Study ID Numbers  ICMJE H19-03882
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Theodore Steiner, University of British Columbia
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of British Columbia
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Crohn's and Colitis Canada
  • Vancouver Island Health Authority
Investigators  ICMJE
Principal Investigator: Ted Steiner, MD University of British Columbia
PRS Account University of British Columbia
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP