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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
lyophilized FMT given orally (10 capsules) twice weekly for total of 8 weeks
lyophilized FMT given via enema (1) twice weekly for total of 8 weeks
placebo given orally (10 capsules) twice weekly for total of 8 weeks
University of Alberta Hospital
Edmonton, Alberta, Canada
Vancouver General Hospital
Vancouver, British Columbia, Canada
Royal Jubilee Hospital
Victoria, British Columbia, Canada
Remission of UC
achievement of remission of UC as defined by Mayo score ≤ 2 AND Mayo endoscopic score of ≤ 1
Time frame: 9 weeks following receipt of LYO-FMT
Incidence/absence of adverse events upon treatment with LYO-FMT [safety and tolerability]
Safety of LYO-FMT in patients with active UC as determined by absence of adverse events
Time frame: up to 5 years post-FMT
UC disease progression
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
Time frame: immediately after FMT (study) treatment period up to 5 years post-FMT
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
placebo given via enema (1) twice weekly for total of 8 weeks