RecruitingPHASE2INTERVENTIONAL

FAecal Microbiota Transplantation in primaRy sclerosinG chOlangitis

The FARGO trial is a UK study exploring whether a 'healthy gut bacteria transplant' (Faecal Microbiota Transplant, or FMT) can benefit people with Primary Sclerosing Cholangitis (PSC) who also have Inflammatory Bowel Disease (IBD). PSC is a chronic liver condition without a cure, and many affected individuals also experience IBD. Research suggests an imbalance of gut bacteria might worsen these conditions. This trial aims to see if restoring this balance through FMT can reduce symptoms and improve quality of life. Participants will be randomly assigned to receive either the FMT treatment or a placebo (dummy treatment), with careful monitoring over 50 weeks. The study hopes to understand if FMT is an effective new approach for managing these conditions.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

University of Birmingham

Enrolment target

Start

27 Mar 2024

Estimated completion

28 Feb 2027

Primary Sclerosing Cholangitis Inflammatory Bowel Diseases

What is this study about?

The FARGO trial is an important UK research study looking into Primary Sclerosing Cholangitis (PSC), a long-term liver condition that currently has no medical treatment proven to slow its progress. Many people with PSC also develop Inflammatory Bowel Disease (IBD). Recently, scientists have noticed that people with both PSC and IBD often have an imbalance of the "good" and "bad" bacteria, viruses, and fungi in their gut, known as the gut microbiome. This imbalance is thought to play a role in developing and possibly worsening the liver problems seen in PSC.

This trial is investigating a treatment called Faecal Microbiota Transplant (FMT), sometimes called a 'healthy gut bacteria transplant'. The idea behind FMT is to restore a healthy balance of gut bacteria by introducing stool (poo) from a healthy donor into the gut of someone with PSC. If successful, it's hoped this could lead to fewer symptoms of both PSC and IBD, and ultimately improve a person's overall quality of life.

FMT involves carefully prepared stool collected from anonymous healthy donors who have undergone strict screening and testing to ensure it's as clean and safe as possible. While this might sound unusual, FMT has been safely used in other conditions like certain types of gut infections (Clostridioides difficile, or C. diff) and other inflammatory bowel conditions. The FARGO trial will involve 58 patients, where half will receive the FMT treatment and the other half a dummy treatment (placebo), to fairly compare the effects.

Key takeaways

The FARGO trial is investigating a new treatment (FMT) for PSC and IBD.
It aims to see if restoring gut bacteria balance can improve symptoms.
Half of participants will receive FMT, half a placebo, to compare effects.
The study involves regular visits over 50 weeks for assessments and monitoring.
FMT is prepared from carefully screened healthy donors and has shown a good safety record.
Taking part is voluntary, and you can withdraw at any time.

Who may be eligible?

To join the FARGO trial, you would need to be at least 18 years old and capable of understanding what's involved. You must have a confirmed diagnosis of both Primary Sclerosing Cholangitis (PSC) and Inflammatory Bowel Disease (IBD) that affects your colon. Your liver disease should be in an early to moderate stage, meaning there's some scarring but not advanced cirrhosis. We'd also look for certain blood test results related to your liver that are consistently above normal levels.

It's important that your IBD is not severely active at the time of screening, and you shouldn't have any signs of abnormal cell changes (dysplasia/neoplasia) in your colon. If you're already taking medications for your IBD or for PSC that overlaps with autoimmune hepatitis, these treatments need to have been at a stable dose for at least 12 weeks before joining the trial, and you should expect to stay on that same dose throughout the study. We won't be able to include individuals whose PSC is caused by other specific conditions, or if their IBD is very active.

Quick self-check

Are you 18 years old or older?
Do you have a diagnosis of both Primary Sclerosing Cholangitis (PSC) and Inflammatory Bowel Disease (IBD) that affects your colon?
Is your PSC considered early to moderate stage (not advanced cirrhosis)?
Are any medications you take for IBD or similar conditions at a stable dose for at least the last 12 weeks?
Do you currently have a diagnosis of moderate to severe active IBD related symptoms?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in the FARGO trial, your involvement will last for 50 weeks. This includes an initial 2-week 'screening' period to confirm you meet all the requirements. Following this, you would receive 8 treatments over 8 weeks. After your treatments, there will be follow-up appointments for up to 48 weeks.

During your time in the trial, you'll have several visits to either study centres or hospitals across England. These visits will involve discussions about your health history, blood tests, and stool tests. If you could become pregnant, you'll also have pregnancy tests. We'll review your current medications, assess specific measures related to your PSC and IBD, and ask you to complete questionnaires about your well-being. We'll also monitor any symptoms or side effects you might experience. For research purposes, additional blood, urine, stool, and colon tissue samples will be collected.

Potential risks and benefits

Taking part in any clinical trial involves both potential benefits and risks. You might benefit from the close medical attention you'll receive throughout the trial. If the FMT treatment proves effective, you could experience an improvement in your PSC and IBD symptoms and overall quality of life; however, there's no guarantee this will happen, especially as half of participants will receive a placebo. Potential risks are generally low with FMT, as it has a good safety record in other conditions, but side effects can occur, such as temporary digestive upset. All medical procedures carry some level of risk, which the study team will fully explain. You have the right to withdraw from the trial at any time, for any reason, without it affecting your usual medical care.

Locations (5)

Queen Elizabeth Hospital Birmingham, University Hospitals Birmingham NHS Foundation Trust
Birmingham, United Kingdom· Recruiting
St Mark's Hospital, London North West University Healthcare NHS Trust
London, United Kingdom· Recruiting
Royal Free Hospital, Royal Free London NHS Foundation Trust
London, United Kingdom· Recruiting
King's College Hospital, King's College Hospital NHS Foundation Trust
London, United Kingdom· Recruiting
John Radcliffe Hospital, Oxford University Hospitals NHS Foundation Trust
Oxford, United Kingdom· Recruiting

Common questions

What is Primary Sclerosing Cholangitis (PSC)?

PSC is a chronic liver disease where the bile ducts (tubes that carry bile from the liver) become inflamed and scarred, which can eventually damage the liver.

What is Inflammatory Bowel Disease (IBD)?

IBD is a term for conditions like Crohn's disease and ulcerative colitis, where parts of the digestive system become inflamed.

What is Faecal Microbiota Transplant (FMT)?

FMT involves gently introducing stool from a healthy donor into your gut to help restore a healthy balance of gut bacteria.

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

No, this is a 'blinded' trial, meaning neither you nor your study doctor will know whether you are receiving the FMT or the placebo until the end of the study. This helps ensure fair results.

Can I leave the study at any time?

Yes, your participation is completely voluntary. You can decide to leave the study at any point, and your regular medical care will not be affected.

How to find out more

Helen Coulthard

FARGO@trials.bham.ac.uk +44 (0121) 3718198 Official trial record

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