Fecal Microbiota Transplant for Ulcerative Colitis Flare
Screening Donors, Fecal Microbiota Transplant Program in Ulcerative Colitis
Recruiting
N/AInterventional Study
Ulcerative Colitis Flare
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
200 (estimated)
Sponsor
Hamilton Health Sciences Corporation · Other
Who this trial is looking for
This trial is looking for adult patients with active ulcerative colitis. Participants will receive a fecal microbiota transplant to see if it can help improve their condition.
Are You a Good Fit for This Trial?
You may be able to join if
I am 18 years old or older
I have active ulcerative colitis
I have a Mayo score greater than 3
I have a Mayo endoscopic score greater than 0
I can use acceptable contraception if I am a woman of child-bearing potential
You may not be able to join if
I am participating in another study for ulcerative colitis
I cannot give informed consent
I have a severe medical illness
I have severe ulcerative colitis that requires hospitalization
I have increased my ulcerative colitis therapy in the last 12 weeks
I have taken antibiotics in the last 30 days
I am pregnant
I have significant liver or kidney dysfunction
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 pa…
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.
Trial Locations
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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
…
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.
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