FMT for Remission of Active Ulcerative Colitis in Adults

Study Purpose

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. This is multi-site, randomized double-blind, placebo-controlled trial. UC patients with active disease will be recruited at three Canadian centres and the study involves 3 treatment arms: 1. FMT oral capsules + placebo enema. 2. placebo oral capsules + placebo enema. 3. FMT oral capsules and FMT enema The primary outcome is achievement of remission of UC; the efficacy of LYO-FMT in achieving remission of active ulcerative colitis in adults will be evaluated.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04202211
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of British Columbia
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Ted Steiner, MD
Principal Investigator Affiliation	University of British Columbia
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries	Canada
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Ulcerative Colitis, Inflammatory Bowel Diseases

Arms & Interventions

Arms

Placebo Comparator: Placebo oral & enema

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

Active Comparator: LYO-FMT oral + placebo enema

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

Active Comparator: LYO-FMT oral + LYO-FMT enema

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

Interventions

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.