Actively Recruiting

Phase 2
Age: 18Years +
All Genders
ID06286709

FARGO: A Randomised, Phase IIa, Multi-centre, Placebo-controlled Trial of Faecal Microbiota Transplantation in Primary Sclerosing Cholangitis

Led by University of Birmingham · Updated on 2026-04-29

58

Participants Needed

5

Research Sites

43 weeks

Total Duration

On this page

Sponsors

U

University of Birmingham

Lead Sponsor

P

PSC Support

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating Faecal Microbiota Transplant (FMT) compared to placebo in patients with primary sclerosing cholangitis (PSC) who also have inflammatory bowel disease (IBD). PSC is a chronic liver disease without proven medical therapies to slow progression, and many patients also develop IBD. Imbalances in the gut microbiome are thought to contribute to disease progression, and this trial aims to study whether FMT can restore gut balance and improve symptoms and quality of life. The trial is a randomized, double-blind, placebo-controlled phase IIa study involving 58 patients. Participants receive either FMT or placebo over 8 weeks, with 8 treatments administered via colonoscopy or enema using carefully screened donor stool or placebo solution. The placebo consists of saline and glycerol. The trial includes a 2-week screening period, 8 weeks of treatment, and follow-up for up to 48 weeks after randomization. Participants will attend clinic visits for health history collection, blood and stool tests, pregnancy tests if applicable, medication reviews, and questionnaires about their disease and symptoms. Additional samples such as blood, urine, stool, and colonic biopsies will be collected for research. The main outcome measured is serum alkaline phosphatase over time, alongside other laboratory tests, biomarkers of liver fibrosis, patient-reported outcomes, and monitoring of adverse events. Total involvement lasts about 50 weeks.

CONDITIONS

Brief Title

FAecal Microbiota Transplantation in primaRy sclerosinG chOlangitis

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Written informed consent
  • Age 18 years or older
  • Ability to understand and comply with study procedures
  • Established diagnosis of colonic inflammatory bowel disease with willingness for annual colonoscopy
  • Established diagnosis of large duct primary sclerosing cholangitis confirmed by imaging
  • Persistent elevated alkaline phosphatase levels (at least 2 readings over 6 months before screening)
  • Evidence of early to moderate liver fibrosis by VCTE score, biopsy, or enhanced liver fibrosis score
  • Colonoscopy within 24 months showing no dysplasia or neoplasia
  • No active colitis (Partial Mayo Score ≤4, rectal bleeding score <2)
  • Stable dose of biologics, immunosuppression or corticosteroids for at least 12 weeks prior to screening
  • If autoimmune hepatitis features present, stable immunosuppression and evidence of colitis
Not Eligible

You will not qualify if you...

  • Secondary causes of sclerosing cholangitis (e.g., IgG4-related cholangitis, AIDS cholangiopathy, drug-induced, trauma)
  • Other liver diseases (e.g., viral hepatitis, alcohol-related liver disease, metabolic fatty liver disease, hereditary conditions)
  • Clinically significant dominant bile duct strictures unless stable and no planned intervention
  • Presence of percutaneous drain or bile duct stent
  • Evidence or concern of hepatic decompensation within 12 weeks prior to screening
  • Advanced liver dysfunction based on bilirubin, albumin, platelet count, CTP or MELD scores
  • Recent ascending cholangitis or antibiotic use within 12 weeks
  • Listed or likely to be listed for liver transplant during trial
  • Small duct PSC
  • Advanced liver fibrosis beyond defined thresholds
  • Significant kidney dysfunction or dialysis
  • HIV infection
  • Recent symptomatic SARS-CoV-2 infection
  • Recent or ongoing malignancy except certain skin or cervical cancers
  • History of bowel resection except specific surgeries
  • Pregnancy or breastfeeding
  • Women not willing to use effective contraception during and 4 weeks after treatment
  • Excessive alcohol consumption
  • Positive drug or stool infection tests at screening
  • Participation in other investigational drug trials recently
  • Recent changes in certain medications or use of antibiotics, probiotics, or prebiotics

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - 8 weeks

Participants receive 8 treatments of Faecal Microbiota Transplant or placebo over 8 weeks to investigate effects on Primary Sclerosing Cholangitis.

Weekly visits for 8 weeks

Follow-up

Duration - Up to 40 weeks

Participants are monitored for safety and efficacy for up to 40 weeks after treatment ends, including assessments of liver function, disease activity, and quality of life.

Visits at Weeks 12, 24, 36, and 48 post-randomisation

Trial Site Locations

Total: 5 locations

1

Queen Elizabeth Hospital Birmingham, University Hospitals Birmingham NHS Foundation Trust

Birmingham, United Kingdom, B15 2TH

Actively Recruiting

2

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

London, United Kingdom, NW10 7NS

Actively Recruiting

3

Royal Free Hospital, Royal Free London NHS Foundation Trust

London, United Kingdom, NW3 2QG

Actively Recruiting

4

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

London, United Kingdom, SE5 9RS

Actively Recruiting

5

John Radcliffe Hospital, Oxford University Hospitals NHS Foundation Trust

Oxford, United Kingdom, OX3 9DU

Actively Recruiting

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Research Team

H

Helen Coulthard

A

Anna Rowe

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

FAecal micRobiota transplantation in primary sclerosinG chOlangitis (FARGO): study protocol for a randomised, multicentre, phase IIa, placebo-controlled trial.

Sarah Al-Shakhshir, Mohammed Nabil Quraishi, Benjamin Mullish...

https://pubmed.ncbi.nlm.nih.gov/39762111