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Microbiota Transplant

Fecal Microbiota Transplant for Ulcerative Colitis (FUEL Trial)

N/A
Recruiting
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
Must not have
Severe UC requiring hospitalization
Unable to give informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 9 weeks and 3 years
Awards & highlights
No Placebo-Only Group

Summary

This trial involves using FMT, where stool from a healthy donor is placed into the gut of patients with active UC. The goal is to see if this can help balance their gut bacteria and reduce symptoms. Many patients will participate to evaluate the effectiveness of this treatment. FMT has been shown to be effective in treating recurrent Clostridium difficile infection and is being explored for its potential in treating ulcerative colitis.

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My ulcerative colitis is active with a Mayo score over 3.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been hospitalized for severe ulcerative colitis.
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I am unable to understand and give consent for treatment.
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My liver tests are not more than 5 times the normal limit.
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My kidney function is normal; my serum creatinine is not above 300 µmol/L.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~9 weeks and 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 9 weeks and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Efficacy of FMT at maintaining remission in UC
Efficacy of FMT donors at inducing UC remission
Secondary study objectives
Adverse effects of FMT
Efficacy of FMT at improving Quality of life
Efficacy of FMT at in inducing histological remission in active UC
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Ulcerative Colitis (UC) often target the gut microbiota to reduce inflammation and improve symptoms. Fecal Microbiota Transplantation (FMT) involves transferring stool from a healthy donor to a UC patient to restore a balanced gut microbiota, potentially inducing remission. Probiotics aim to modify the intestinal microbiota to reduce inflammation, while antibiotics like rifaximin target small intestinal bacterial overgrowth to alleviate symptoms. These treatments emphasize the critical role of gut microbiota in managing UC, offering potential non-pharmacological options for patients.

Find a Location

Who is running the clinical trial?

Hamilton Health Sciences CorporationLead Sponsor
377 Previous Clinical Trials
339,729 Total Patients Enrolled
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,392 Previous Clinical Trials
26,529,245 Total Patients Enrolled
Paul Moayyedi, MDPrincipal InvestigatorHHSC/McMaster
2 Previous Clinical Trials
8,075 Total Patients Enrolled

Media Library

Fecal Microbiota Transplant (Microbiota Transplant) Clinical Trial Eligibility Overview. Trial Name: NCT04926103 — N/A
Flare Up Research Study Groups: Open label FMT therapy
Flare Up Clinical Trial 2023: Fecal Microbiota Transplant Highlights & Side Effects. Trial Name: NCT04926103 — N/A
Fecal Microbiota Transplant (Microbiota Transplant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04926103 — N/A
~120 spots leftby Oct 2028