Fecal microbiota transplant program for ulcerative colitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Hamilton Health Sciences / McMaster University
  Hamilton, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Paul Moayyedi, MD — HHSC/McMaster
• Study coordinator: Melanie A Wolfe, CCRP
• Email: wolfe@hhsc.ca
• Phone: 9055212100

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.