Screening Donors, Fecal Microbiota Transplant Program in Ulcerative Colitis

NCT ID: NCT04926103

Last Updated: 2024-10-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2029-05-01

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.

Conditions

Ulcerative Colitis Flare

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Open label FMT therapy

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

Group Type: EXPERIMENTAL

Fecal Microbiota transplant (FMT)

Intervention Type: OTHER

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

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

Hamilton Health Sciences Corporation

OTHER

Sponsor Role: lead

Responsible Party

Paul Moayyedi

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paul Moayyedi, MD

Role: PRINCIPAL_INVESTIGATOR

HHSC/McMaster

Locations

Hamilton Health Sciences / McMaster University

Hamilton, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Melanie A Wolfe, CCRP

Role: CONTACT

wolfe@hhsc.ca

9055212100 ext. 22060

Aida Fernandes, MBA

Role: CONTACT

fernaa19@mcmaster.ca

289-921-6483

Facility Contacts

Paul Moayyedi, MD

Role: primary

moayyep@mcmaster.ca

905-521-2100 ext. 76764

Melanie A Wolfe, CCRP

Role: backup

wolfe@hhsc.ca

905-521-2100 ext. 22060

Paul Moayyedi, MD

Role: backup

References

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.

Reference Type: BACKGROUND

PMID: 25857665 (View on PubMed)

Other Identifiers

FUEL001

Identifier Type: -

Identifier Source: org_study_id