Screening Donors, Fecal Microbiota Transplant Program in Ulcerative Colitis

NCT04926103 | Recruiting

• 1 other identifier: FUEL001
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Efficacy of FMT donors at inducing UC remission

  Suitability of FMT donors at inducing remission in active UC (remission defined as a Mayo score (7) \< 3 with an endoscopic Mayo score = 0 at the end of 8 weeks of FMT).

  9 weeks

• Efficacy of FMT at maintaining remission in UC

  Maintenance of remission of UC after three years in those who achieve initial remission with FMT. This is defined as no relapse over three years that requires any medical therapy other than more intense FMT therapy

  3 years

Secondary Outcomes (6)

• Efficacy of FMT at in inducing histological remission in active UC

  9 weeks

• Efficacy of FMT at relieving PRO2 symptoms

  9 weeks

• Efficacy of FMT at improving Quality of life

  9 weeks and 3 years

• Adverse effects of FMT

  3 years

• Stool microbiota predicting FMT success

  9 weeks

Study Arms (1)

Open label FMT therapy

EXPERIMENTAL

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

Other: Fecal Microbiota transplant (FMT)

Interventions

Fecal Microbiota transplant (FMT) 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

Open label FMT therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 or over
• Active UC defined as a Mayo score (7) \>3
• A Mayo endoscopic score (7) \>0
• 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

You may not qualify if:

• Participating in another intervention study for UC
• Unable to give informed consent
• Severe comorbid medical illness
• Severe UC requiring hospitalization.
• 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.
• Antibiotic therapy in the last 30 days.
• Pregnant women.
• Patients with clinically significant hepatic dysfunction at the time of screening: ALT \> 5 times the upper normal range.
• Patients with clinically significant renal dysfunction at the time of screening: serum creatinine \> 300 µmol/L
• Any condition, in the opinion of the investigator, that the treatment may pose a health risk to the subject.

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Hamilton Health Sciences / McMaster University

Hamilton, Ontario, L8N 3Z5, Canada

RECRUITING

Related Publications (1)

• 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.

  PMID: 25857665 BACKGROUND

MeSH Terms

Interventions

Fecal Microbiota Transplantation

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Paul Moayyedi, MD

  HHSC/McMaster

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melanie A Wolfe, CCRP

CONTACT

9055212100; wolfe@hhsc.ca

Aida Fernandes, MBA

CONTACT

289-921-6483; fernaa19@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: This is an open label study with all UC patients receiving FMT.

Study Record Dates

• First Submitted: May 12, 2021
• First Posted: June 14, 2021
• Study Start: July 1, 2022
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): May 1, 2029
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will be available after study completion - estimated 7 years
• Access Criteria: Any researcher evaluating the efficacy of FMT in ulcerative colitis

Locations

CA (1)