Actively Recruiting
Screening Donors, Fecal Microbiota Transplant Program in Ulcerative Colitis
Led by Hamilton Health Sciences Corporation · Updated on 2024-10-01
200
Participants Needed
1
Research Sites
356 weeks
Total Duration
On this page
Sponsors
H
Hamilton Health Sciences Corporation
Lead Sponsor
C
Canadian Institutes of Health Research (CIHR)
Collaborating Sponsor
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Screening Donors, Fecal Microbiota Transplant Program in Ulcerative Colitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 or over
- Active ulcerative colitis defined by a Mayo score greater than 3
- Mayo endoscopic score greater than 0
- Females of child-bearing potential must be willing and able to use acceptable contraception as per guidance
You will not qualify if you...
- Participation in another intervention study for ulcerative colitis
- Unable to give informed consent
- Severe comorbid medical illness
- Severe ulcerative colitis requiring hospitalization
- Increase in medical therapy for ulcerative colitis in the last 12 weeks (stable doses of certain medications allowed)
- Antibiotic therapy in the last 30 days
- Pregnant women
- Clinically significant liver dysfunction (ALT > 5 times normal)
- Clinically significant kidney dysfunction (serum creatinine > 300 �b5mol/L)
- Any condition that the investigator believes poses a health risk with treatment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Hamilton Health Sciences / McMaster University
Hamilton, Ontario, Canada, L8N 3Z5
Actively Recruiting
Research Team
M
Melanie A Wolfe, CCRP
CONTACT
A
Aida Fernandes, MBA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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