What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Common treatments for Ulcerative Colitis (UC) include Fecal Microbiota Transplantation (FMT), mesalamine, corticosteroids, and immunosuppressants. FMT, which involves transferring stool from a healthy donor to a UC patient, may cause infection and gastrointestinal symptoms. Mesalamine can lead to headaches, nausea, and abdominal pain. Corticosteroids are linked to weight gain, osteoporosis, and increased infection risk. Immunosuppressants like azathioprine may result in bone marrow suppression and liver toxicity. Each treatment has unique side effects, and therapy should be tailored to the individual patient in consultation with a healthcare provider.

What prior FDA approvals exist?

The FDA has approved several treatments for Ulcerative Colitis, including biologics like infliximab, adalimumab, and vedolizumab, which target specific components of the immune system to reduce inflammation. While Fecal Microbiota Transplantation (FMT) is being studied for its potential to induce remission in UC patients by modifying the gut microbiota, it has not yet received FDA approval specifically for UC. Other approved treatments include aminosalicylates, corticosteroids, and immunomodulators, which help manage inflammation and maintain remission.

What other types of research exist?

Promising novel alternatives to Fecal Microbiota Transplantation for Ulcerative Colitis patients include the use of specific probiotics, such as Lactobacillus reuteri, which have shown potential in clinical studies. Additionally, dietary interventions like the Mediterranean diet, which is easier to comply with and beneficial for overall health, may also be considered. Further research into the use of mesenchymal stem cells for nonhealing perianal fistulas in Crohn's disease suggests potential applicability for UC as well. These alternatives offer new avenues for inducing and maintaining remission in UC patients.

← Back to Search

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

Select...

I am 18 years old or older.

Select...

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:

Select...

I have been hospitalized for severe ulcerative colitis.

Select...

I am unable to understand and give consent for treatment.

Select...

My liver tests are not more than 5 times the normal limit.

Select...

My kidney function is normal; my serum creatinine is not above 300 µmol/L.

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

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

0 / 6Eligibility criteria met

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.