FAecal Microbiota Transplantation in primaRy sclerosinG chOlangitis
Trial Parameters
Eligibility Fast-Check
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Brief Summary
FARGO is a randomised, phase IIa, multi-centre, placebo-controlled trial to compare Faecal Microbiota Transplant (FMT) with placebo in patients with primary sclerosing cholangitis (PSC) and concomitant inflammatory bowel disease.
Eligibility Criteria
Inclusion Criteria: 1. Written informed consent 2. Age ≥ 18 years 3. Participants must be able to understand and comply with the purpose and procedures that are involved in the trial 4. An established diagnosis of colonic inflammatory bowel disease, with willingness to participate in an annual colonoscopic surveillance program, as per routine standard of care 5. An established clinical diagnosis of large duct PSC, with compatible features as assessed by magnetic resonance cholangiopancreatography (MRCP) or endoscopic retrograde cholangiopancreatography (ERCP) 6. A persistent ALP value above normal (at least 2 readings at this value over 6 months before screening) 7. Evidence of early to moderate stage liver fibrosis, as suspected by any of the following: 1. Median VCTE score of ≤14.4kPa, with an interquartile range ≤30% 2. Previous liver biopsy indicating at an absence of established cirrhosis, Ishak fibrosis stage \<IV (or equivalent) in the last 24 months 3. Serum enhanced liver fibr