Exploring the potential of a new treatment to slow the progression of PSC: the FARGO trial

Status: Ongoing

Primary sclerosing cholangitis (PSC) is a rare liver disease where the body attacks itself, causing inflammation and scarring of the bile ducts and liver. This causes bile to stop flowing properly, leading to repeated infections, liver failure and, in some cases, cancer. In 80% of people with PSC the body will also attack the bowel, which can lead to inflammatory bowel disease (IBD). The combination of the two conditions results in a 15-30% lifetime risk of bowel cancer, and patients require a colonoscopy every year to look for this complication.

Despite impressive research in the last decade, there is still no cure for PSC, nor any medication that has been shown to improve survival. Liver transplantation is the only lifesaving treatment for some PSC patients. Although a very rare disease, PSC accounts for 10-15% of all liver transplants performed in the UK and is now the leading reason for transplantation in several European countries. Moreover, PSC returns in around a third of people who have had a liver transplant.

Project aims

Our FARGO Trial (FAecal microbiota transplantation in primaRy sclerosinG chOlangitis) will explore the potential of a new treatment to slow the progression of PSC and improve quality of life for people with PSC. This study will test the safety and long-term effects of Faecal Microbiota Transplantation (FMT) as a treatment for people with PSC. It will also improve understanding around which specific micro-organisms in donor stool are most important, and how this information can be used to enhance the product for large scale rollout.

This is the first ever multi-centre double-blind placebo controlled trial of FMT in PSC-associated IBD, and is funded by Lifearc and PSC Support and supported and run by the University of Birmingham Cancer Clinical Trials Unit.