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Microbiota Transplant
Fecal Microbiota Transplant for Ulcerative Colitis (FUEL Trial)
N/A
Waitlist Available
Led By Paul Moayyedi, MD
Research Sponsored by Hamilton Health Sciences Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients aged 18 or over
Active UC defined as a Mayo score >3
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 9 weeks and 3 years
Awards & highlights
FUEL Trial Summary
This trial is looking for new donors for fecal matter transplantation (FMT) to treat active ulcerative colitis (UC). FMT donors may not be effective in inducing remission in all patients, and some may induce remission in 20-40% of cases. The trial will follow UC patients that have responded to FMT long term to see if maintenance FMT results in long term remission.
Who is the study for?
This trial is for adults over 18 with active Ulcerative Colitis, as shown by a Mayo score greater than 3. Participants must not be in another UC study, hospitalized for severe UC, or have had recent changes in their UC medication. Women who can have children must agree to use contraception.Check my eligibility
What is being tested?
The trial is testing the effectiveness of fecal microbiota transplants (FMT) from new donors on patients with Ulcerative Colitis. It aims to see if FMT can induce remission and maintain it long-term.See study design
What are the potential side effects?
While specific side effects are not listed here, FMT generally may cause digestive discomfort, bloating, diarrhea or constipation. There's also a risk of infection transmission from donor stool.
FUEL Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
My ulcerative colitis is active with a Mayo score over 3.
FUEL Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 9 weeks and 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~9 weeks and 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Efficacy of FMT at maintaining remission in UC
Efficacy of FMT donors at inducing UC remission
Secondary outcome measures
Adverse effects of FMT
Efficacy of FMT at improving Quality of life
Efficacy of FMT at in inducing histological remission in active UC
+3 moreFUEL Trial Design
1Treatment groups
Experimental Treatment
Group I: Open label FMT therapyExperimental Treatment1 Intervention
FMT from a related or unrelated healthy donor screened for known communicable disease
Find a Location
Who is running the clinical trial?
Hamilton Health Sciences CorporationLead Sponsor
368 Previous Clinical Trials
300,801 Total Patients Enrolled
3 Trials studying Ulcerative Colitis
8,205 Patients Enrolled for Ulcerative Colitis
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,345 Previous Clinical Trials
26,453,314 Total Patients Enrolled
4 Trials studying Ulcerative Colitis
8,483 Patients Enrolled for Ulcerative Colitis
Paul Moayyedi, MDPrincipal InvestigatorHHSC/McMaster
2 Previous Clinical Trials
8,075 Total Patients Enrolled
2 Trials studying Ulcerative Colitis
8,075 Patients Enrolled for Ulcerative Colitis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been hospitalized for severe ulcerative colitis.My ulcerative colitis is active with a Mayo score above 3.I am willing to use birth control as required.I have not taken antibiotics in the last 30 days.My ulcerative colitis medication has been increased in the last 3 months.I am unable to understand and give consent for treatment.I am 18 years old or older.My ulcerative colitis is active with a Mayo score over 3.My liver tests are not more than 5 times the normal limit.My kidney function is normal; my serum creatinine is not above 300 µmol/L.I've been on a stable dose of specific medications for my condition for at least 12 weeks.You have a Mayo endoscopic score (7) >0.
Research Study Groups:
This trial has the following groups:- Group 1: Open label FMT therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there vacancies in this research project for volunteers?
"According to the information on clinicaltrials.gov, this study is not looking for patients at the moment. The trial was posted on 7/1/2022 and was last updated on 3/15/2022. However, there are 414 other studies that are recruiting patients."
Answered by AI
Who else is applying?
What state do they live in?
New York
How old are they?
18 - 65
What site did they apply to?
Hamilton Health Sciences / McMaster University
What portion of applicants met pre-screening criteria?
Did not meet criteria
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