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Studies

Interventional Recruiting Phase 2

NCT06286709 on ClinicalTrials.gov

FAecal Microbiota Transplantation in primaRy sclerosinG chOlangitis

Official title: FARGO: A Randomised, Phase IIa, Multi-centre, Placebo-controlled Trial of FAecal Microbiota Transplantation in primaRy sclerosinG chOlangitis

  • Sponsor: University of Birmingham
  • Collaborators: PSC Support, Life Arc
  • Enrollment: 58 (Estimated)
  • Study start: 2024-03-27 (Actual)
  • Primary completion: 2027-09-30 (Estimated)
  • Study completion: 2027-09-30 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • InterventionModelDescription: Phase IIa, multi-centre, randomised, placebo-controlled, single-blinded, parallel group, clinical trial
  • Masking: Double (Participant, Investigator)
  • PrimaryPurpose: Treatment

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.

Conditions

  • Primary Sclerosing Cholangitis
  • Inflammatory Bowel Diseases

Intervention / Treatment

  • Biological: Faecal Microbiota Transplant
  • Other: FMT Placebo

Primary Outcome Measures

  • Serum Alkaline Phosphatase (ALP) (ALP at Screening (Week -2), Week 1, Week 3, Week 5, Week 8, Week 12, Week 24, Week 36 and Week 48)
    Reduction in serum ALP values from baseline, measured at 48 weeks following the first dose of FMT or FMT Placebo.

Countries

United Kingdom

Locations and Investigators

  • Queen Elizabeth Hospital Birmingham, University Hospitals Birmingham NHS Foundation Trust, Birmingham, United Kingdom (Recruiting)
    • Palak Trivedi (Principal Investigator)
  • St Mark's Hospital, London North West University Healthcare NHS Trust, London, United Kingdom (Recruiting)
    • Ailsa Hart (Principal Investigator)
  • Royal Free Hospital, Royal Free London NHS Foundation Trust, London, United Kingdom (Recruiting)
    • Douglas Thorburn (Principal Investigator)
  • King's College Hospital, King's College Hospital NHS Foundation Trust, London, United Kingdom (Recruiting)
    • Deepak Joshi (Principal Investigator)
  • John Radcliffe Hospital, Oxford University Hospitals NHS Foundation Trust, Oxford, United Kingdom (Recruiting)
    • Emma Culver (Principal Investigator)