RecruitingOBSERVATIONAL

Fecal Microbiota Transplant National Registry

This is a national registry, which means it's collecting information from many people across North America who are having a treatment called faecal microbiota transplantation (FMT). FMT involves transferring healthy gut bacteria from one person to another. This study aims to track patients for up to 10 years to learn more about how safe and effective FMT is in the long term, especially for conditions like recurrent C. difficile infection. By gathering details about the treatment process and how patients are doing afterwards, researchers hope to improve our understanding of this treatment and identify any potential benefits or risks over time. It's an important step in learning more about the gut microbiome and how we can use it to help people.

At a glance

Status

Recruiting

Sponsor

American Gastroenterological Association

Enrolment target

4,000

Start

20 Sep 2017

Estimated completion

01 Aug 2027

Fecal Microbiota Transplantation Clostridium Difficile Infection Gut Microbiome

What is this study about?

This study is called the Fecal Microbiota Transplant National Registry. It's not a clinical trial where you try out a new treatment; instead, it's like a large-scale observation project. Researchers are simply gathering information from people across North America who are already undergoing a treatment called faecal microbiota transplantation (FMT) or similar treatments involving gut bacteria. FMT involves taking healthy gut bacteria from a donor and transferring them to a patient, often to help treat conditions like stubborn C. difficile infections.

The main goal of this registry is to keep a close eye on how patients are doing after their FMT. They want to understand both the short-term and long-term safety of the procedure, as well as how well it works. This means collecting details about how the FMT was done, why it was given, and then regularly checking in with patients for up to 10 years afterwards. By doing this, they hope to build a clearer picture of FMT's benefits and any potential concerns.

Collecting this information from many different individuals and clinics will help doctors and scientists learn a great deal. It will allow them to see patterns, understand what works best, and identify any issues that might come up over time. Ultimately, this knowledge can help improve how FMT is given and make it safer and more effective for future patients.

Key takeaways

This study collects information on people already receiving faecal microbiota transplantation (FMT).
It aims to understand the long-term safety and how well FMT works.
Patients will be followed for up to 10 years.
You won't receive extra treatments for this study.
Your participation helps improve FMT for future patients.
You can stop being part of the study at any time.

Who may be eligible?

If you're thinking about taking part, you would need to be receiving a faecal microbiota transplant (FMT) or a similar gut-related bacteria product. This treatment must happen within 90 days of you agreeing to be part of the study. You also need to be able to understand what you're agreeing to and give your permission. Lastly, you’ll need to have access to the internet or a telephone so the researchers can keep in touch with you.

This study is also collecting information from donors. If you are donating a stool sample for FMT, you would need to be able to understand the study and agree to take part.

There are not many reasons why someone *wouldn't* be able to join. The main reason listed is if you are currently in prison.

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 receiving faecal microbiota transplantation (FMT) or a similar gut bacteria product.
My FMT will happen within 90 days of joining the study.
I understand and can give my permission to be part of the study.
I have access to the internet or a telephone.

Answer every question to see your result.

What does participation involve?

If you decide to take part, you won't be given any new treatments or medications just for the study, as it's an observational project. The researchers will collect information about the faecal microbiota transplant (FMT) you are already receiving, including details about how it's prepared and given. They will also gather some basic information about your health before the FMT.

After your FMT, the study team will follow your progress for a long time – up to 10 years. Your healthcare provider will share updates about your health at 1 month, 6 months, 1 year, and 2 years after your FMT. Additionally, the researchers will contact you directly at least once a year for up to 10 years to check in and see how you're doing. This is to gather information on both the short-term and long-term effects of the treatment.

Potential risks and benefits

Because this is an observational study, you won't be given any experimental treatments, so there aren't direct health risks from taking part. The main benefit is that you'll be contributing valuable information that helps doctors and scientists understand faecal microbiota transplantation (FMT) better. This could lead to improved treatments and care for others in the future. The only potential 'risk' might be the time involved in follow-up calls or filling out questionnaires. You are completely free to withdraw from the study at any time without giving a reason, and this will not affect your medical care.

Locations (53)

Phoenix Children's Hospital
Verified postcode
Phoenix, United States· Withdrawn
Children's Hospital of Los Angeles
Verified postcode
Los Angeles, United States· Active not recruiting
University of California
Verified postcode
Los Angeles, United States· Withdrawn
Stanford University
Verified postcode
Redwood City, United States· Recruiting
Sutter Roseville Medical Center
Verified postcode
Roseville, United States· Recruiting
University of California San Francisco
Verified postcode
San Francisco, United States· Recruiting
Ventura Clinical Trials
Verified postcode
Ventura, United States· Withdrawn
Yale New Haven Hospital
Verified postcode
Hamden, United States· Recruiting
MedStar Georgetown University Hospital
Verified postcode
Georgetown, United States· Active not recruiting
Best Quality Research, Inc.
Verified postcode
Hialeah, United States· Withdrawn
University of Miami, Miller School of Medicine
Verified postcode
Miami, United States· Recruiting
GI Pros
Verified postcode
Naples, United States· Withdrawn

Common questions

What is faecal microbiota transplantation (FMT)?

FMT is a treatment where healthy gut bacteria from a donor's stool are transferred to a patient, usually to help restore a healthy balance of bacteria in their gut.

Is this study giving out FMT as a treatment?

No, this study is only observing people who are already receiving FMT as part of their medical care. It's not providing the treatment itself.

How long will I be involved in this study?

You could be followed for up to 10 years after your FMT, with regular check-ins from your doctor and direct contact from the study team.

Will my personal information be kept private?

The study will collect information to understand treatment safety and effectiveness. Researchers are committed to protecting your privacy, but you should always ask specifically about data protection measures.

What is a 'gut microbiome'?

The gut microbiome is the collection of trillions of bacteria and other tiny organisms living in your digestive system. They play a big role in your health.

How to find out more

Sonya Serra, MSc

sserra@gastro.org 3019412616 Official trial record

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