nctId: NCT06286709 id: RG_22-063 briefTitle: FAecal Microbiota Transplantation in primaRy sclerosinG chOlangitis acronym: FARGO overallStatus: NOT_YET_RECRUITING date: 2024-02-29 date: 2026-04-30 date: 2026-07-29 date: 2024-02-29 date: 2024-02-29 name: University of Birmingham class: OTHER name: PSC Support name: Life Arc briefSummary: 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. conditions: Primary Sclerosing Cholangitis conditions: Inflammatory Bowel Diseases studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Phase IIa, multi-centre, randomised, placebo-controlled, single-blinded, parallel group, clinical trial primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Single-blind whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 58 type: ESTIMATED name: Faecal Microbiota Transplant name: FMT Placebo measure: Serum Alkaline Phosphatase (ALP) measure: Patient-reported outcome (PRO) measures measure: Patient-reported outcome (PRO) measures measure: Patient-reported outcome (PRO) measures measure: Patient-reported outcome (PRO) measures measure: Surrogate biomarkers of liver fibrosis measure: Surrogate biomarkers of liver fibrosis measure: Routine liver laboratory parameters measure: Routine liver laboratory parameters measure: Routine liver laboratory parameters measure: Routine liver laboratory parameters measure: Routine liver laboratory parameters measure: PSC specific prognostic scores measure: PSC specific prognostic scores measure: Quantitative assessment of Inflammatory Bowel Disease (IBD) activity measure: Quantitative assessment of IBD activity measure: Quantitative assessment of IBD activity measure: The incidence of clinical non-trial endpoint events measure: The incidence of trial endpoint events measure: Occurrence of adverse events sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Queen Elizabeth Hospital Birmingham, University Hospitals Birmingham NHS Foundation Trust city: Birmingham zip: B15 2TH country: United Kingdom name: Palak Trivedi role: PRINCIPAL_INVESTIGATOR lat: 52.48142 lon: -1.89983 facility: St Mark's Hospital, London North West University Healthcare NHS Trust city: London zip: NW10 7NS country: United Kingdom name: Ailsa Hart role: PRINCIPAL_INVESTIGATOR lat: 51.50853 lon: -0.12574 facility: Royal Free Hospital, Royal Free London NHS Foundation Trust city: London zip: NW3 2QG country: United Kingdom name: Douglas Thorburn role: PRINCIPAL_INVESTIGATOR lat: 51.50853 lon: -0.12574 facility: King's College Hospital, King's College Hospital NHS Foundation Trust city: London zip: SE5 9RS country: United Kingdom name: Deepak Joshi role: PRINCIPAL_INVESTIGATOR lat: 51.50853 lon: -0.12574 facility: Norfolk and Norwich University Hospital, Norfolk and Norwich University Hospitals NHS Foundation Trust city: Norwich zip: NR4 7UY country: United Kingdom name: Simon Rushbrook role: PRINCIPAL_INVESTIGATOR lat: 52.62783 lon: 1.29834 facility: John Radcliffe Hospital, Oxford University Hospitals NHS Foundation Trust city: Oxford zip: OX3 9DU country: United Kingdom name: Emma Culver role: PRINCIPAL_INVESTIGATOR lat: 51.75222 lon: -1.25596 hasResults: False