FMT for Remission of Active Ulcerative Colitis in Adults

NCT04202211 | Withdrawn Phase 2 DMC

• 1 other identifier: H19-03882
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 3

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. 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.

Conditions

Ulcerative Colitis; Inflammatory Bowel Diseases

Keywords

ulcerative colitis; Fecal Microbiota transplant; FMT; Inflammatory bowel disease; IBD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Incidence/absence of adverse events upon treatment with LYO-FMT [safety and tolerability]

  up to 5 years post-FMT

• UC disease progression

  immediately after FMT (study) treatment period up to 5 years post-FMT

Study Arms (3)

Placebo oral & enema

PLACEBO COMPARATOR

twice weekly x 8 weeks: 10 placebo oral capsules + placebo enema

Other: Placebo oral; Other: Placebo enema

LYO-FMT oral + placebo enema

ACTIVE COMPARATOR

twice weekly x 8 weeks: 10 LYO-FMT oral capsules + 1 placebo enema

Biological: FMT oral; Other: Placebo enema

LYO-FMT oral + LYO-FMT enema

ACTIVE COMPARATOR

twice weekly x 8 weeks: 10 LYO-FMT oral capsules + 1 LYO-FMT enema

Biological: FMT oral; Biological: FMT enema

Interventions

FMT oral BIOLOGICAL

lyophilized FMT given orally (10 capsules) twice weekly for total of 8 weeks

LYO-FMT oral + LYO-FMT enema; LYO-FMT oral + placebo enema

FMT enema BIOLOGICAL

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

LYO-FMT oral + LYO-FMT enema

Placebo oral OTHER

placebo given orally (10 capsules) twice weekly for total of 8 weeks

Placebo oral & enema

Placebo enema OTHER

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

LYO-FMT oral + placebo enema; Placebo oral & enema

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead
• Crohn's and Colitis Canada: collaborator

Study Sites (3)

University of Alberta Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Royal Jubilee Hospital

Victoria, British Columbia, V8R 1J8, Canada

Location

MeSH Terms

Conditions

Colitis, Ulcerative; Inflammatory Bowel Diseases

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Ted Steiner, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Professor

Study Record Dates

• First Submitted: December 13, 2019
• First Posted: December 17, 2019
• Study Start: March 1, 2022
• Primary Completion: December 1, 2024
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 10, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)