RecruitingPhase 2NCT06286709

FAecal Microbiota Transplantation in primaRy sclerosinG chOlangitis

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


Sponsor

University of Birmingham

Enrollment

58 participants

Start Date

Mar 27, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying FMT Placebo and a biological treatment called Faecal Microbiota Transplant for people with inflammatory bowel diseases and primary sclerosing cholangitis. The study is currently recruiting participants at 5 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALFaecal Microbiota Transplant

FMT is 50mL aliquots of filtered suspension of stool (0.6g/mL). FMT for administration via colonoscopy will be made up of 150g stool in 250mL (5 aliquots). FMT for administration via enema will be made up of 30g stool in 50mL (1 aliquot) made up to 100mL by the addition of 50mL normal saline

OTHERFMT Placebo

FMT Placebo is 50mL aliquots containing 0.9% w/v saline and glycerol in a ratio of 9 parts saline: 1 part glycerol v/v. FMT Placebo for administration via colonoscopy will be made up of 250mL (5 aliquots). FMT Placebo for administration via enema will be made up of 50mL (1 aliquot) made up to 100mL by the addition of 50mL normal saline


Locations(5)

Queen Elizabeth Hospital Birmingham, University Hospitals Birmingham NHS Foundation Trust

Birmingham, United Kingdom

St Mark's Hospital, London North West University Healthcare NHS Trust

London, United Kingdom

Royal Free Hospital, Royal Free London NHS Foundation Trust

London, United Kingdom

King's College Hospital, King's College Hospital NHS Foundation Trust

London, United Kingdom

John Radcliffe Hospital, Oxford University Hospitals NHS Foundation Trust

Oxford, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT06286709


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