The first patient has been recruited for the FARGO clinical trial, funded by LifeArc and PSC Support, which explores a new treatment for patients with primary sclerosing cholangitis (PSC), a rare liver disease.
Improving quality of life for PSC patients
The Fargo trial is being conducted by the University of Birmingham and investigates the potential of faecal microbiota transplantation (FMT) to correct gut microbiome imbalances in PSC patients. The hope is that this could slow or even reverse the disease’s progression and ultimately improve quality of life for patients.
“Should this trial show that FMT works well, PSC Support will be advocating for patients to access FMT as early as possible. We hope this means it will be making a difference to patients within five years after we’ve completed this work.”
Dr. Catriona Crombie, Head of Rare Disease at LifeArc
The FARGO trial is the first-ever multi-centre, double-blind, placebo-controlled study of FMT in PSC. It aims to recruit 58 patients across various sites in England, including Birmingham, Royal Free London, St Mark’s Hospital, Imperial College London, and Norfolk and Norwich University Hospitals NHS Foundation Trust. Participants will receive either FMT once a week for eight weeks or a placebo.
The FMT procedure involves collecting stool from healthy donors, refining it in a laboratory, and then transferring it to the bowels of PSC patients. The initial administration is integrated with the annual routine colonoscopy undertaken by PSC patients to optimize their experience and avoid unnecessary appointments. Subsequent FMT courses are administered via enema over the next seven weeks.
Previous research has demonstrated that FMT is safe and effective in treating inflammatory bowel disease and Clostridioides difficile infection. The trial builds on the expertise and support of the University of Birmingham’s Microbiome Treatment Centre (MTC), the first Medicines and Healthcare products Regulatory Agency (MHRA) licensed facility in the UK to provide FMT for clinical trials and treatment of recurrent and refractory Clostridiodes difficile infection. The Birmingham Cancer Research UK Clinical Trials Unit (CRCTU) will run the trial, renowned for its academic excellence and innovative research in both cancer and non-cancer fields like inflammatory diseases.
Trial lead Dr Palak Trivedi, Clinician Scientist at the National Institute for Health and Care Research (NIHR) Birmingham Biomedical Research Centre, Associate Professor at the University of Birmingham and Consultant Hepatologist, commented: “We are very excited to have our first patient joining this innovative trial. There is currently no cure or medication for primary sclerosing cholangitis, and this is the first time worldwide that FMT treatment is being investigated for patients with the disease.”
“We are grateful to our patients for helping us in our mission to find new treatments that may significantly improve the lives of people affected by this devastating disease.”
Media contact
Hannah Severyn
Head of Media and PR at LifeArc