Screening Donors, Fecal Microbiota Transplant Program in Ulcerative Colitis
Not applicable · Testing Fecal Microbiota transplant (FMT) · 1 site · Hamilton Health Sciences Corporation
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Fecal Microbiota transplant (FMT) as a possible treatment. Condition(s) listed: Ulcerative Colitis Flare.
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- Patients aged 18 or over
- Active UC defined as a Mayo score (7) >3
- A Mayo endoscopic score (7) >0
Plus 1 more requirement(s). There are also 10 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 200 participants are expected to take part.
- Start date: 2022-07-01.
- Main results expected around 2028-10-01 (estimate from the record).
- 1 study site listed (1 marked recruiting) in Canada.
Main thing being measured
- Efficacy of FMT donors at inducing UC remission (9 weeks)
In the researchers’ words
The investigators intend to screen for new donors, given that there may a donor effect (PubMed ID: 25857665), with some donors not inducing remission in any patient whilst others inducing remission in 20-40% of cases. It is important to give UC patients participating in RCTs stool that has been demonstrated to be effective in some patients.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Ulcerative Colitis Flare |
| Lead sponsor | Hamilton Health Sciences Corporation |
| Collaborators | Canadian Institutes of Health Research (CIHR) |
| Enrollment | 200 (estimated) |
| Start date | 2022-07-01 |
| Primary completion (est.) | 2028-10-01 |
| First posted | 2021-06-14 |
| Last updated | 2024-10-01 |
| Official title | Screening Donors for a Fecal Microbiota Transplant Program in Ulcerative Colitis: Evaluating Efficacy and Long-term Effects. the FUEL Study |
| ClinicalTrials.gov ID | NCT04926103 |
Interventions
- Fecal Microbiota transplant (FMT) (Other)
Patients will come once a week for FMT for 8 weeks. FMT is the administration of the supernatant component of stool and water mixture from a healthy relative or an unrelated donor. The donor's stool and blood is rigorously screened to exclude known communicable diseases. Those that achieve remission with FMT will have the option of continuing FMT once per month for 3 years
Full eligibility criteria (from the record)
Inclusion Criteria: 1. Patients aged 18 or over 2. Active UC defined as a Mayo score (7) >3 3. A Mayo endoscopic score (7) >0 4. Females of child-bearing potential must be willing and able to use acceptable contraception as per Appendix III. II. b. Toxicity section of the Health Canada Guidance Exclusion Criteria: 1. Participating in another intervention study for UC 2. Unable to give informed consent 3. Severe comorbid medical illness 4. Severe UC requiring hospitalization. 5. Increase in medical therapy for UC in the last 12 weeks. Continued treatment with 5-ASA, azathioprine, 6-mercaptopurine or anti-TNF therapy (e.g. infliximab) will be permitted if taken at stable dose for ≥12 weeks prior to randomization. Relapse on a stable dose (same dose for at least 2 weeks) or a tapering dose of steroids will also be permitted provided the dose of steroid is not increased again. Stable intake of probiotic therapy also permitted. 6. Antibiotic therapy in the last 30 days. 7. Pregnant women. 8. Patients with clinically significant hepatic dysfunction at the time of screening: ALT > 5 times the upper normal range. 9. Patients with clinically significant renal dysfunction at the time of screening: serum creatinine > 300 µmol/L 10. Any condition, in the opinion of the investigator, that the treatment may pose a health risk to the subject.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Hamilton Health Sciences / McMaster University | Hamilton, Ontario | Canada | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.