FMT for Remission of Active Ulcerative Colitis in Adults

Phase 2

Withdrawn

• Conditions: Inflammatory Bowel Diseases; Ulcerative Colitis
• Interventions: Other: Placebo oral; Biological: FMT oral; Other: Placebo enema; Biological: FMT enema

• Registration Number: NCT04202211
• Lead Sponsor: 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. 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-12-13
• Study First Submitted QC: 2019-12-13
• Study First Posted: 2019-12-17
• Study Start: 2022-03
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-08
• Last Update Posted: 2023-05-10
• Primary Completion: 2024-12
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo oral & enema	Placebo oral	twice weekly x 8 weeks: 10 placebo oral capsules + placebo enema
LYO-FMT oral + placebo enema	FMT oral	twice weekly x 8 weeks: 10 LYO-FMT oral capsules + 1 placebo enema
LYO-FMT oral + placebo enema	Placebo enema	twice weekly x 8 weeks: 10 LYO-FMT oral capsules + 1 placebo enema
LYO-FMT oral + LYO-FMT enema	FMT oral	twice weekly x 8 weeks: 10 LYO-FMT oral capsules + 1 LYO-FMT enema
Placebo oral & enema	Placebo enema	twice weekly x 8 weeks: 10 placebo oral capsules + placebo enema
LYO-FMT oral + LYO-FMT enema	FMT enema	twice weekly x 8 weeks: 10 LYO-FMT oral capsules + 1 LYO-FMT enema

Primary Outcome Measures

Name	Time	Method
Remission of UC	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

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

Trial Locations

Locations (3)

University of Alberta Hospital; 🇨🇦 Edmonton, Alberta, Canada

Royal Jubilee Hospital; 🇨🇦 Victoria, British Columbia, Canada

Vancouver General Hospital; 🇨🇦 Vancouver, British Columbia, Canada