FMT for Remission of Active Ulcerative Colitis in Adults

University of British Columbia

Status and phase: Withdrawn; Phase 2

Conditions: Ulcerative Colitis; Inflammatory Bowel Diseases

Treatments: Biological: FMT oral; Biological: FMT enema; Other: Placebo oral; Other: Placebo enema

Study type: Interventional

Funder types: Other

Identifiers

NCT04202211

H19-03882

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 3 patient groups, including a placebo group

Placebo oral & enema

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo oral

Other: Placebo enema

LYO-FMT oral + placebo enema

Active Comparator group

Description:

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

Treatment:

Biological: FMT oral

Other: Placebo enema

LYO-FMT oral + LYO-FMT enema

Active Comparator group

Description:

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

Treatment:

Biological: FMT oral

Biological: FMT enema