NCT04926103Recruiting
Screening Donors, Fecal Microbiota Transplant Program in Ulcerative Colitis
Screening Donors for a Fecal Microbiota Transplant Program in Ulcerative Colitis: Evaluating Efficacy and Long-term Effects. the FUEL Study
Source: ClinicalTrials.gov · Last updated 1 Oct 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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. We therefore propose to conduct an open label study in patients with active UC to ensure new donors are effective at inducing remission in some patients. Patients that have FMT will relapse within 18 months (PubMed ID: 25857665) although further FMT therapy induces remission so it is possible that maintenance FMT will result in long term remission, but this needs evaluation. We will therefore follow UC patients that have responded to FMT long term in this open label study.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 12 May 2021
- Start date
- 1 Jul 2022
- Primary completion date
- 1 Oct 2028
- Lead sponsor
- Hamilton Health Sciences Corporation
- Diseases
- Ulcerative colitis
- NCT number
- NCT04926103
What you commit to
- Study type: Interventional
- Planned participants: 200
- From 1 Jul 2022 to the primary completion date, 1 Oct 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Antibiotic therapy in the last 30 days.
Other illness
- Severe comorbid medical illness
- Any condition, in the opinion of the investigator, that the treatment may pose a health risk to the subject.
Lab values
- Patients with clinically significant hepatic dysfunction at the time of screening: ALT \> 5 times the upper normal range.
- Patients with clinically significant renal dysfunction at the time of screening: serum creatinine \> 300 µmol/L
Other
- Participating in another intervention study for UC
- Unable to give informed consent
- Severe UC requiring hospitalization.
- Pregnant women.
Who the study is looking for
- Patients aged 18 or over
- Active UC defined as a Mayo score (7) \>3
- A Mayo endoscopic score (7) \>0
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hamilton Health Sciences , Mcmaster University Coordinator of this site? Confirm its status | Hamilton | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.