Clinical trial NCT04202211: FMT for Remission of Active Ulcerative Colitis in Adults
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Ulcerative Colitis
Inflammatory Bowel Diseases
Keywords: ulcerative colitis
Fecal Microbiota transplant
FMT
Inflammatory bowel disease
IBD
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Crohn's and Colitis Canada
First posted: 2019-12-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Remission of UC
timeFrame: 9 weeks following receipt of LYO-FMT
Secondary outcomes:
measure: Incidence/absence of adverse events upon treatment with LYO-FMT [safety and tolerability]
timeFrame: up to 5 years post-FMT
measure: UC disease progression
timeFrame: immediately after FMT (study) treatment period up to 5 years post-FMT
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Victoria
country: Canada
facility: Royal Jubilee Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Ted Steiner, MD
role: PRINCIPAL_INVESTIGATOR
References: