Screening Donors, Fecal Microbiota Transplant Program in Ulcerative Colitis (FUEL)

Hamilton Health Sciences (HHS)

Status: Enrolling

Conditions: Ulcerative Colitis Flare

Treatments: Other: Fecal Microbiota transplant (FMT)

Study type: Interventional

Funder types: Other

Identifiers

NCT04926103

FUEL001

Details and patient eligibility

About

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.

Full description

This is an open label study with all UC patients receiving FMT. Up to 200 patients with active UC will be recruited to the study.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

200 participants in 1 patient group

Open label FMT therapy

Experimental group

Description:

FMT from a related or unrelated healthy donor screened for known communicable disease

Treatment:

Other: Fecal Microbiota transplant (FMT)