FMT for Remission of Active Ulcerative Colitis in Adults

A Randomized Double-blind, Placebo-controlled Trial of Lyophilized Fecal Microbiota Transplantation for the Induction of Remission in Adults With Active Ulcerative Colitis

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. The protocol is being re-designed to address relevant, current research questions in the context of FMT treatment for UC. Once a final protocol is approved, this webpage will be updated.

Study Overview

• Status: Withdrawn
• Conditions: Inflammatory Bowel Diseases; Ulcerative Colitis
• Intervention / Treatment: Other: Placebo oral; Other: Placebo enema; Biological: FMT oral; Biological: FMT enema

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Laura Oliveira; Phone Number: 64164 604 875 4111; Email: laura.oliveira@ubc.ca

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2B7
      • University of Alberta Hospital
      • Contact: Rose Franz; Email: Rose.Franz@albertahealthservices.ca
      • Principal Investigator: Dina Kao, MD
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • Vancouver General Hospital
      • Contact: Laura Oliveira; Phone Number: 64164 604 875 4111; Email: laura.oliveira@ubc.ca
      • Principal Investigator: Ted Steiner, MD
    • Victoria, British Columbia, Canada, V8R 1J8
      • Royal Jubilee Hospital
      • Contact: Peyman Goldeh; Email: Peyman.Goldeh@VIHA.CA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / 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	Other: Placebo enema; placebo given via enema (1) twice weekly for total of 8 weeks; Biological: FMT oral; lyophilized FMT given orally (10 capsules) 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Remission of UC	achievement of remission of UC as defined by Mayo score ≤ 2 AND Mayo endoscopic score of ≤ 1	9 weeks following receipt of LYO-FMT

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence/absence of adverse events upon treatment with LYO-FMT [safety and tolerability]	Safety of LYO-FMT in patients with active UC as determined by absence of adverse events	up to 5 years post-FMT
UC disease progression	Determine progression of UC based on development of any of the following: Clinical flare of UC requiring hospitalization up to 3 months post-FMT; Increase in dosages of current UC specific medications up to 3 months' post FMT; Time to colectomy for UC flare up to 12 months' post FMT; Time to death directly attributable to UC up to 5 years post FMT; Improvement in clinical response defined by decrease in Partial Mayo score by ≥ 3 points from pre to post LYO-FMT.; 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; Reduction in biologic inflammatory markers (serum c-reactive protein (CRP) and fecal calprotectin) from pre to post LYO-FMT	immediately after FMT (study) treatment period up to 5 years post-FMT

Collaborators and Investigators

• Sponsor: University of British Columbia
• Collaborators: Crohn's and Colitis Canada
• Investigators: Principal Investigator: Ted Steiner, MD, University of British Columbia

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2022
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): December 1, 2028

Study Registration Dates

• First Submitted: December 13, 2019
• First Submitted That Met QC Criteria: December 13, 2019
• First Posted (Actual): December 17, 2019

Study Record Updates

• Last Update Posted (Actual): May 10, 2023
• Last Update Submitted That Met QC Criteria: May 8, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: IBD; ulcerative colitis; FMT; Inflammatory bowel disease; Fecal Microbiota transplant
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Ulcer; Inflammatory Bowel Diseases; Intestinal Diseases; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: H19-03882

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No