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