Trial | NCT04202211  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Withdrawn

  • Study Participants

    0
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 Started
Mar 31
2022
Anticipated
Primary Completion
Dec 31
2024
Anticipated
Study Completion
Dec 31
2028
Anticipated
Last Update
May 10
2023

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

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

Placebo oral & enema Placebo Comparator

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

LYO-FMT oral + placebo enema Active Comparator

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

LYO-FMT oral + LYO-FMT enema Active Comparator

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

Criteria 

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
No Results Posted