ClinicaliQ Trial Snapshot
- FAecal Microbiota Transplantation in primaRy sclerosinG chOlangitis — Recruiting • Phase II • Rheumatology • NCT06286709.
- Intervention being tested: Faecal Microbiota Transplant (FMT) versus placebo in patients with primary sclerosing cholangitis (PSC), a rare autoimmune liver disease with no established disease-modifying therapy beyond ursodeoxycholic acid.
- Patient eligibility overview: Adults with PSC who have concomitant inflammatory bowel disease (IBD), representing the subset at highest risk of progressive liver disease and meeting inclusion criteria for this phase IIa randomised controlled trial.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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 Snapshot
- : 1. Written informed consent 2. Age ≥ 18 years
- 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 45 µmol/L is allowable), serum albumin 15 7. Ascending cholangitis as assessed clinically within twelve weeks of screening 8. Use of antibiotics within twelve weeks of screening
- Participant already listed for liver transplantation, or concerns (investigator discretion) that they may need to be listed for liver transplantation during the trial period 10. Small duct PSC 11. Advanced-stage liver fibrosis,…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.