RecruitingPHASE2INTERVENTIONAL

Fecal Microbiota Transplantation for Pouchitis

This study is investigating a new way to treat pouchitis, which is inflammation that can sometimes affect people who have had surgery for ulcerative colitis. We're testing a treatment called Fecal Microbiota Transplantation (FMT), which involves giving patients healthy gut bacteria from a screened donor. For six weeks, some patients will receive this FMT treatment once a week, while others will receive a dummy treatment (placebo). The aim is to see if FMT can help calm down the inflammation and improve symptoms better than the dummy treatment. This is a blinded study, meaning neither the patients nor the doctors will know who is getting the active treatment. It's an important step in finding better ways to manage pouchitis.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

McMaster University

Enrolment target

Start

17 Apr 2019

Estimated completion

30 Sep 2025

Pouchitis

What is this study about?

When people have severe ulcerative colitis, they sometimes need an operation to remove their large bowel. After this, doctors can create an internal pouch from a part of the small bowel. This pouch acts like a new rectum. However, sometimes this pouch can get inflamed, a condition known as pouchitis. It's quite common, affecting about half of all people who have this surgery, and often it can come back again and again.

While we don't fully understand why pouchitis happens, we do know that the bacteria in the gut seem to play a role. Currently, antibiotics are often used to treat pouchitis. While they can work well, using them repeatedly can lead to side effects and concerns about antibiotics becoming less effective over time. This means we need to find other options for managing pouchitis.

This study is looking at a treatment called Fecal Microbiota Transplantation (FMT). In simple terms, FMT involves introducing healthy gut bacteria from a carefully checked donor into a patient's bowel. The idea is that these healthy bacteria can help rebalance the gut, which might be helpful for conditions like pouchitis. FMT has been successfully used to treat other gut problems, particularly a serious infection called C. difficile. We want to see if a similar approach can help improve pouchitis for people in this study.

Key takeaways

This study investigates Fecal Microbiota Transplantation (FMT) for pouchitis.
It aims to see if FMT can reduce gut inflammation and improve symptoms.
Participants will receive either FMT or a dummy treatment (placebo) for six weeks.
The study is 'blinded', meaning no one knows who gets which treatment.
It's a step towards finding new treatment options for pouchitis.
You can withdraw from the study at any time.

Who may be eligible?

To join this study, you need to be 18 years or older and currently have active pouchitis. Doctors will check the severity of your pouchitis using a special scoring system. If you're a woman who could become pregnant, you'll need to agree to use reliable birth control during the study.

There are some reasons why you wouldn't be able to join. For example, if you're already taking part in another medical study or if you have other serious health problems that could make it unsafe for you. Also, if you have a C. difficile infection at the same time, you wouldn't be able to participate. Most importantly, you need to be able to understand the study and agree to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I am 18 years old or older.
I currently have active pouchitis.
If I am a woman, I am willing and able to use reliable birth control during the study.
I am not currently taking part in another medical study.
I do not have a serious medical condition that would prevent me from joining.
I do not have a C. difficile infection.

Answer every question to see your result.

What does participation involve?

If you decide to participate, you will receive either the active treatment (Fecal Microbiota Transplantation, or FMT) or a dummy treatment (placebo). This will be given once a week for six weeks. Neither you nor the study team will know which treatment you are receiving. Over the course of these six weeks, there will be assessments to monitor your symptoms and how you are responding to the treatment. The total duration of active treatment and close monitoring within the study is six weeks, with further follow-ups to track your progress.

Potential risks and benefits

Taking part in this study could potentially offer a new way to manage your pouchitis, possibly reducing inflammation and improving your symptoms. However, as with any new treatment, there might be unknown risks or side effects from receiving healthy gut bacteria. You will be closely monitored for any changes or reactions. It is important to remember that you can stop participating in the study at any time, for any reason, without it affecting your medical care.

Locations (1)

McMaster University
Verified postcode
Hamilton, Canada· Recruiting

Common questions

What is pouchitis?

Pouchitis is when the internal pouch, created after surgery for ulcerative colitis, gets inflamed.

What is Fecal Microbiota Transplantation (FMT)?

FMT is a treatment where healthy gut bacteria from a screened donor are given to a patient to help rebalance their gut.

Will I know if I'm getting the real treatment or a dummy treatment?

No, neither you nor the doctors will know. This helps us get clearer results from the study.

How long will I be in the study?

The main treatment and monitoring period will be for six weeks, with additional follow-ups.

Where is this study taking place?

This study is being conducted at McMaster University in Hamilton, Ontario, Canada.

How to find out more

Neeraj Narula

narulan@mcmaster.ca 905-521-2100 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.