Fecal microbiota transplant program for ulcerative colitis

Screening Donors for a Fecal Microbiota Transplant Program in Ulcerative Colitis: Evaluating Efficacy and Long-term Effects. the FUEL Study

This study is testing whether using fecal transplants from different donors can help people with active ulcerative colitis feel better and stay in remission.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Hamilton Health Sciences Corporation (Academic / other)
• Drugs / interventions: infliximab
• Locations: 1 site (Hamilton, Ontario)
• Trial ID: NCT04926103 on ClinicalTrials.gov

What this trial studies

This study aims to screen new donors for fecal microbiota transplants (FMT) to treat patients with active ulcerative colitis (UC). It will involve recruiting up to 200 patients who will receive FMT, with the goal of evaluating the effectiveness of different donors in inducing remission. The study will follow patients long-term to assess the potential for maintenance FMT to achieve sustained remission. The open-label design allows for real-time assessment of donor efficacy in a clinical setting.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and over with active ulcerative colitis as defined by specific Mayo scores.

Not a fit: Patients with severe UC requiring hospitalization or those participating in other intervention studies may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more effective treatments for ulcerative colitis, improving patient outcomes and quality of life.

How similar studies have performed: Previous studies have indicated varying success with fecal microbiota transplants in UC, suggesting that while this approach has shown promise, the specific donor effect remains an area of ongoing investigation.

Eligibility criteria

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.

Where this trial is running

Hamilton, Ontario

• Hamilton Health Sciences / McMaster University — Hamilton, Ontario, Canada (Recruiting)

Study contacts

• Principal investigator: Paul Moayyedi, MD — HHSC/McMaster
• Study coordinator: Melanie A Wolfe, CCRP

Conditions Ulcerative Colitis Flare