Ulcerative Colitis, Inflammatory Bowel Diseases
Conditions
Keywords
ulcerative colitis, Fecal Microbiota transplant, FMT, Inflammatory bowel disease, IBD
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.
Interventions
BIOLOGICALFMT oral
lyophilized FMT given orally (10 capsules) twice weekly for total of 8 weeks
BIOLOGICALFMT enema
lyophilized FMT given via enema (1) twice weekly for total of 8 weeks
OTHERPlacebo oral
placebo given orally (10 capsules) twice weekly for total of 8 weeks
OTHERPlacebo enema
placebo given via enema (1) twice weekly for total of 8 weeks
Sponsors
Crohn's and Colitis Canada
University of British Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Remission of UC | 9 weeks following receipt of LYO-FMT | achievement of remission of UC as defined by Mayo score ≤ 2 AND Mayo endoscopic score of ≤ 1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence/absence of adverse events upon treatment with LYO-FMT [safety and tolerability] | up to 5 years post-FMT | Safety of LYO-FMT in patients with active UC as determined by absence of adverse events |
| UC disease progression | immediately after FMT (study) treatment period up to 5 years post-FMT | Determine progression of UC based on development of any of the following: 1. Clinical flare of UC requiring hospitalization up to 3 months post-FMT 2. Increase in dosages of current UC specific medications up to 3 months' post FMT 3. Time to colectomy for UC flare up to 12 months' post FMT 4. Time to death directly attributable to UC up to 5 years post FMT 5. Improvement in clinical response defined by decrease in Partial Mayo score by ≥ 3 points from pre to post LYO-FMT. 6. 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 7. Reduction in biologic inflammatory markers (serum c-reactive protein (CRP) and fecal calprotectin) from pre to post LYO-FMT |
Countries
Canada
Outcome results
None listed