Actively Recruiting
FAecal Microbiota Transplantation in primaRy sclerosinG chOlangitis
Led by University of Birmingham · Updated on 2026-04-29
58
Participants Needed
5
Research Sites
152 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
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
Official Title
FAecal Microbiota Transplantation in primaRy sclerosinG chOlangitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent
- Age 18 years or older
- Ability to understand and comply with trial procedures
- Established diagnosis of colonic inflammatory bowel disease with willingness for annual colonoscopic surveillance
- Clinical diagnosis of large duct primary sclerosing cholangitis confirmed by MRCP or ERCP
- Persistent alkaline phosphatase (ALP) above normal on at least 2 readings over 6 months before screening
- Evidence of early to moderate liver fibrosis by VCTE score ≤14.4kPa, liver biopsy without cirrhosis (Ishak stage <IV) within 24 months, or enhanced liver fibrosis (ELF) score ≥9.8
- Colonoscopy within 24 months showing no dysplasia or neoplasia
- No evidence of active colitis with Partial Mayo Score ≤4 and rectal bleeding domain score <2 at screening
- Stable treatment with biologics, immunosuppression or corticosteroids for at least 12 weeks prior to screening and expected to continue same dose during trial
- Patients with overlapping autoimmune hepatitis features allowed if immunosuppression dose stable for 12 weeks and evidence of colitis
You will not qualify if you...
- Secondary causes of sclerosing cholangitis such as IgG4-related cholangitis, AIDS cholangiopathy, drug-induced or ischemic cholangiopathy, choledocholithiasis, or post-surgical sclerosing cholangiopathy
- Other liver diseases including viral hepatitis, alcohol-related liver disease, metabolic associated fatty liver disease, drug-induced liver disease, hereditary hemochromatosis, alpha-1-antitrypsin deficiency, primary biliary cholangitis, Wilson disease, Budd-Chiari syndrome, or hepatopancreatobiliary cancer
- Clinically significant dominant stricture not stable for 6 months or requiring intervention
- Presence of percutaneous drain or bile duct stent
- Evidence of hepatic decompensation within 12 weeks prior to screening
- Advanced liver dysfunction with bilirubin >55 µmol/L (except certain conditions), albumin <32 g/L, platelet <140x10^9/L, Child-Pugh score >B7, or MELD score >15
- Ascending cholangitis within 12 weeks prior to screening
- Use of antibiotics within 12 weeks prior to screening
- Listed or likely to be listed for liver transplantation during trial
- Small duct PSC
- Advanced liver fibrosis (VCTE >14.4 kPa or liver biopsy Ishak stage >III)
- Significant renal dysfunction (eGFR <60 ml/min or need for dialysis)
- HIV infection
- Symptomatic positive SARS-CoV-2 test in past 4 weeks
- History of malignancy within 3 years except non-melanoma skin cancer or treated cervical carcinoma in situ
- History or likelihood of small bowel or colonic resection during trial (except subtotal colectomy with ileal pouch anal anastomosis)
- Pregnancy or breastfeeding
- Women of childbearing potential not willing to use effective contraception during trial and 4 weeks after last dose
- Alcohol consumption exceeding 21 units/week for men or 14 units/week for women
- Positive urine drug screen at screening
- Positive stool test for Clostridioides difficile toxin or enteric infection within 12 weeks prior to screening
- Participation in another interventional trial or use of investigational agents within 12 weeks prior to screening
- Recent introduction or dose change within 12 weeks of certain medications including fibric acid derivatives, FXR agonists, anti-motility agents, bile acid sequestrants, or ursodeoxycholic acid
- Use of oral or intravenous antibiotics, probiotics, or prebiotics within 12 weeks prior to screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
Research Team
H
Helen Coulthard
CONTACT
A
Anna Rowe
CONTACT
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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