FAecal Microbiota Transplantation in primaRy sclerosinG chOlangitis
United Kingdom58 participantsStarted 2024-03-27
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Written informed consent
✓. Age ≥ 18 years
✓. Participants must be able to understand and comply with the purpose and procedures that are involved in the trial
✓. An established diagnosis of colonic inflammatory bowel disease, with willingness to participate in an annual colonoscopic surveillance program, as per routine standard of care
✓. An established clinical diagnosis of large duct PSC, with compatible features as assessed by magnetic resonance cholangiopancreatography (MRCP) or endoscopic retrograde cholangiopancreatography (ERCP)
✓. A persistent ALP value above normal (at least 2 readings at this value over 6 months before screening)
✓. Evidence of early to moderate stage liver fibrosis, as suspected by any of the following:
✓. Median VCTE score of ≤14.4kPa, with an interquartile range ≤30%
Exclusion criteria
✕. Secondary causes of sclerosing cholangitis including, but not limited to, IgG4-related cholangitis, cholangiopathy due to acquired immunodeficiency syndrome, drug-induced sclerosing cholangitis, trauma, ischaemic cholangiopathy, choledocholithiasis (investigator discretion), or sclerosing cholangiopathy as a sequelae of hepatopancreatobiliary resection
✕. Other causes of liver disease, including, but not limited to, IgG4-related disease; viral hepatitis; alcohol-related liver disease; clinically significant metabolic associated fatty liver disease (at investigator discretion); drug-induced liver disease; hereditary haemochromatosis; alpha-1-antitrypsin disease; primary biliary cholangitis; Wilson disease; Budd-Chiari Syndrome; or primary or secondary hepatopancreatobiliary cancer
What they're measuring
1
Serum Alkaline Phosphatase (ALP)
Timeframe: ALP at Screening (Week -2), Week 1, Week 3, Week 5, Week 8, Week 12, Week 24, Week 36 and Week 48
✕. Presence of a clinically significant dominant stricture based on the combination of radiological, biochemical and clinical features. Patients can be included in the trial with a dominant extrahepatic stenosis if it has been stable for 6 months or more (as evidenced on imaging and also clinically), and one of the following are satisfied:
✕. The PI does not plan for any biliary intervention (endoscopic, percutaneous or surgical) for the duration of the trial OR
✕. The investigator decides that they do not wish to perform any biliary intervention (endoscopic, percutaneous or surgical) on the dominant stenosis for clinical reasons of stability/patient choice
✕. Presence of a percutaneous drain or bile duct stent
✕. Evidence of hepatic decompensation within twelve weeks prior to screening; or concern by the Principal Investigator that the participant may decompensate during the trial period. Hepatic decompensation as evidenced by variceal haemorrhage, ascites, hepatic hydrothorax, or hepatic encephalopathy (Appendix 1)
✕. Biochemical/laboratory evidence of very advanced hepatic dysfunction, as evidenced by a serum bilirubin value \>55 µmol/L (unless Gilbert Syndrome or another condition associated with unconjugated hyperbilirubinaemia, including but not limited to, spherocytosis and disorders of bilirubin conjugation where a bilirubin value\>45 µmol/L is allowable), serum albumin \<32 g/L, platelet level of \<140x109/L, Child-Turcotte-Pugh (CTP) score \>B7, or a MELD score \>15