Clinical trial NCT04926103: Screening Donors, Fecal Microbiota Transplant Program in Ulcerative Colitis
Official title: Screening Donors for a Fecal Microbiota Transplant Program in Ulcerative Colitis: Evaluating Efficacy and Long-term Effects. the FUEL Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ulcerative Colitis Flare
Lead sponsor: Hamilton Health Sciences Corporation
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2021-06-14
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is an open label study with all UC patients receiving FMT.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

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.

Primary outcomes:
measure: Efficacy of FMT donors at inducing UC remission
timeFrame: 9 weeks
measure: Efficacy of FMT at maintaining remission in UC
timeFrame: 3 years
Secondary outcomes:
measure: Efficacy of FMT at in inducing histological remission in active UC
timeFrame: 9 weeks
measure: Efficacy of FMT at relieving PRO2 symptoms
timeFrame: 9 weeks
measure: Efficacy of FMT at improving Quality of life
timeFrame: 9 weeks and 3 years
measure: Adverse effects of FMT
timeFrame: 3 years
measure: Stool microbiota predicting FMT success
timeFrame: 9 weeks
measure: Mucosal microbiota predicting FMT success
timeFrame: 9 weeks
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton Health Sciences / McMaster University
state: Ontario
Study officials:
affiliation: HHSC/McMaster
name: Paul Moayyedi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Moayyedi P, Surette MG, Kim PT, Libertucci J, Wolfe M, Onischi C, Armstrong D, Marshall JK, Kassam Z, Reinisch W, Lee CH. Fecal Microbiota Transplantation Induces Remission in Patients With Active Ulcerative Colitis in a Randomized Controlled Trial. Gastroenterology. 2015 Jul;149(1):102-109.e6. doi: 10.1053/j.gastro.2015.04.001. Epub 2015 Apr 7.