FMT for Remission of Active Ulcerative Colitis in Adults

Ulcerative Colitis Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04202211
• Other study ID #: H19-03882
• Status: Withdrawn
• Phase: Phase 2
• Start date: March 2022
• Est. completion date: December 2028

Study information

• Verified date: May 2023
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2028
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Ulcer
• Ulcerative Colitis

Intervention

Biological:
• FMT oral
lyophilized FMT given orally (10 capsules) twice weekly for total of 8 weeks
• 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
• Placebo enema
placebo given via enema (1) twice weekly for total of 8 weeks

Locations

Country	Name	City	State
Canada	University of Alberta Hospital	Edmonton	Alberta
Canada	Vancouver General Hospital	Vancouver	British Columbia
Canada	Royal Jubilee Hospital	Victoria	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	Crohn's and Colitis Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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