Fecal Microbiota Transplant for Ulcerative Colitis
What You Need to Know Before You Apply
What is the purpose of this trial?
To compare the safety and efficacy of concomitant LFMT versus placebo in UC patients who are starting vedolizumab or ustekinumab.
Will I have to stop taking my current medications?
The trial requires stopping certain medications before joining. You must stop using rectal/topical therapies 2 weeks before, cyclosporine, tacrolimus, or thalidomide 4 weeks before, and adalimumab or infliximab 8 weeks before. Vedolizumab must be stopped 8 weeks before, and ustekinumab 12 weeks before. Prednisone over 30 mg/day is not allowed.
Is fecal microbiota transplantation (FMT) safe for humans?
Research on fecal microbiota transplantation (FMT) for ulcerative colitis suggests it is generally safe, with studies focusing on its safety and feasibility, including long-term use. While these studies primarily target ulcerative colitis, they provide valuable safety insights for FMT in humans.12345
How is fecal microbiota transplantation different from other treatments for ulcerative colitis?
Fecal microbiota transplantation (FMT) is unique because it involves transferring stool from a healthy donor to a patient to restore a balanced gut microbiome, which is different from traditional drug treatments that target inflammation directly. This approach is novel as it aims to correct gut dysbiosis (imbalance of gut bacteria) rather than just suppressing symptoms.56789
What data supports the effectiveness of the treatment Lyophilized Fecal Microbiota (LFMT) for ulcerative colitis?
Research shows that fecal microbiota transplantation (FMT), including the lyophilized (freeze-dried) form, can help some patients with ulcerative colitis achieve remission, meaning their symptoms improve significantly. One study found that oral lyophilized FMT was effective, with one donor achieving 100% success in inducing remission in patients.1341011
Are You a Good Fit for This Trial?
This trial is for adults aged 18-75 with ulcerative colitis, confirmed by a doctor using standard tests. Participants must have active symptoms and be starting vedolizumab or ustekinumab treatment but can't have used certain medications recently. Women who can bear children must use contraception during the trial.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive LFMT or placebo capsules along with vedolizumab or ustekinumab for 8 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Lyophilized Fecal Microbiota (LFMT)
- Placebo
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Alberta
Lead Sponsor