Recruiting

Fecal Microbiota Transplant

Sponsor:

Hamilton Health Sciences Corporation

Code:

NCT04926103

Conditions

Ulcerative Colitis Flare

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Fecal Microbiota transplant (FMT)

Study Details

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.

Conditions

Ulcerative Colitis Flare

Study ID

NCT04926103

Start date

Jul 1, 2022

Status verified date

Sep, 2024

Completion date

May 1, 2029

Anticipated

Primary completion date

Oct 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

200 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Open label FMT therapy

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

Interventions

Fecal Microbiota transplant (FMT)

Patients will come once a week for FMT for 8 weeks. FMT is the administration of the supernatant component of stool and water mixture from a healthy relative or an unrelated donor. The donor's stool and blood is rigorously screened to exclude known communicable diseases. Those that achieve remission with FMT will have the option of continuing FMT once per month for 3 years

Primary outcome measure

  • Efficacy of FMT donors at inducing UC remission [ Time Frame: 9 weeks ]
  • Efficacy of FMT at maintaining remission in UC [ Time Frame: 3 years ]

Central Contacts and Locations

Central contacts

Melanie A Wolfe, CCRP

9055212100wolfe@hhsc.ca

Locations

Hamilton Health Sciences / McMaster University

Recruiting

Hamilton, Ontario, Canada, L8N 3Z5

Contacts

More Information

Sponsor

Hamilton Health Sciences Corporation

Last update posted

Oct 1, 2024

Last verified

Sep, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hamilton Health Sciences Corporation on 2024-10-01.