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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 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.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 9 weeks and 3 years for reporting.

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 more

FUEL 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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Hamilton Health Sciences CorporationLead Sponsor

366 Previous Clinical Trials

300,705 Total Patients Enrolled

3 Trials studying Ulcerative Colitis

8,205 Patients Enrolled for Ulcerative Colitis

Canadian Institutes of Health Research (CIHR)OTHER_GOV

1,336 Previous Clinical Trials

25,750,810 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

Fecal Microbiota Transplant (Microbiota Transplant) Clinical Trial Eligibility Overview. Trial Name: NCT04926103 — N/A

Ulcerative Colitis Research Study Groups: Open label FMT therapy

Ulcerative Colitis 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

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