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Primary Sclerosing CholangitisPhase 2FARGONCT06286709

FAecal Microbiota Transplantation in primaRy sclerosinG chOlangitis

A Phase 2 study testing Faecal Microbiota Transplant in people with Primary Sclerosing Cholangitis and Inflammatory Bowel Diseases, run by University of Birmingham at 5 sites in United Kingdom.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Faecal Microbiota Transplant
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
58 participants
Where
5 sitesUnited Kingdom
Study dates
27 Mar 2024to 30 Sep 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Written informed consent
  • Age ≥ 18 years
  • Participants must be able to understand and comply with the purpose and procedures that are involved in the trial
  • An established diagnosis of colonic inflammatory bowel disease, with willingness to participate in an annual colonoscopic surveillance program, as per routine standard of care
  • An established clinical diagnosis of large duct PSC, with compatible features as assessed by magnetic resonance cholangiopancreatography (MRCP) or endoscopic retrograde cholangiopancreatography (ERCP)
  • A persistent ALP value above normal (at least 2 readings at this value over 6 months before screening)
Show all 16Show fewer
  • Evidence of early to moderate stage liver fibrosis, as suspected by any of the following:
  • Median VCTE score of ≤14.4kPa, with an interquartile range ≤30%
  • Previous liver biopsy indicating at an absence of established cirrhosis, Ishak fibrosis stage <IV (or equivalent) in the last 24 months
  • Serum enhanced liver fibrosis score (ELF) ≤9.8
  • A colonoscopy showing no evidence of dysplasia/neoplasia within 24 months before screening
  • No evidence of active colitis, as evidenced by a Partial Mayo Score of ≤4, with a score of <2 on the rectal bleeding domain at screening
  • Individuals with IBD who are receiving treatment with biologics, immunosuppression or corticosteroids must be taking a stable dose for at least twelve weeks prior to screening, and be expected to remain on the same medication/same dose for the duration of the trial
  • Individuals with PSC having overlapping features of autoimmune hepatitis may be included, provided:
  • The dosage of immunosuppression has remained stable for at least twelve weeks prior to screening, and be expected to remain on the same medication/same dose for the duration of the trial; and
  • There is evidence of concomitant colitis

Who cannot join

  • Secondary causes of sclerosing cholangitis including, but not limited to, IgG4-related cholangitis, cholangiopathy due to acquired immunodeficiency syndrome, drug-induced sclerosing cholangitis, trauma, ischaemic cholangiopathy, choledocholithiasis (investigator discretion), or sclerosing cholangiopathy as a sequelae of hepatopancreatobiliary resection
  • Other causes of liver disease, including, but not limited to, IgG4-related disease; viral hepatitis; alcohol-related liver disease; clinically significant metabolic associated fatty liver disease (at investigator discretion); drug-induced liver disease; hereditary haemochromatosis; alpha-1-antitrypsin disease; primary biliary cholangitis; Wilson disease; Budd-Chiari Syndrome; or primary or secondary hepatopancreatobiliary cancer
  • Presence of a clinically significant dominant stricture based on the combination of radiological, biochemical and clinical features. Patients can be included in the trial with a dominant extrahepatic stenosis if it has been stable for 6 months or more (as evidenced on imaging and also clinically), and one of the following are satisfied:
  • The PI does not plan for any biliary intervention (endoscopic, percutaneous or surgical) for the duration of the trial OR
  • The investigator decides that they do not wish to perform any biliary intervention (endoscopic, percutaneous or surgical) on the dominant stenosis for clinical reasons of stability/patient choice
  • Presence of a percutaneous drain or bile duct stent
Show all 26Show fewer
  • Evidence of hepatic decompensation within twelve weeks prior to screening; or concern by the Principal Investigator that the participant may decompensate during the trial period. Hepatic decompensation as evidenced by variceal haemorrhage, ascites, hepatic hydrothorax, or hepatic encephalopathy (Appendix 1)
  • Biochemical/laboratory evidence of very advanced hepatic dysfunction, as evidenced by a serum bilirubin value >55 µmol/L (unless Gilbert Syndrome or another condition associated with unconjugated hyperbilirubinaemia, including but not limited to, spherocytosis and disorders of bilirubin conjugation where a bilirubin value>45 µmol/L is allowable), serum albumin <32 g/L, platelet level of <140x109/L, Child-Turcotte-Pugh (CTP) score >B7, or a MELD score >15
  • Ascending cholangitis as assessed clinically within twelve weeks of screening
  • Use of antibiotics within twelve weeks of screening
  • Participant already listed for liver transplantation, or concerns (investigator discretion) that they may need to be listed for liver transplantation during the trial period
  • Small duct PSC
  • Advanced-stage liver fibrosis, as evidenced by a VCTE score >14.4kPa, a liver biopsy showing >Ishak stage III fibrosis (or equivalent)
  • Significant renal dysfunction as evidenced by an estimated glomerular filtration rate of <60 ml/min according to the Cockcroft-Gault formula, or need for dialysis
  • Human Immunodeficiency Virus (HIV) infection
  • A symptomatic positive test result for Serious Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in the four weeks prior to screening
  • History of malignancy within the past three years, or ongoing malignancy, other than non-melanomatous skin cancer, or treated cervical carcinoma in situ
  • Any history of small bowel or colonic resection, or likelihood of resection during the trial period. Individuals with a sub-total colectomy and ileal pouch anal anastomosis are permitted to participate.
  • Patients who are pregnant or breastfeeding
  • Women of childbearing potential (see Appendix 2 for definition) who confirm they are not willing to practise effective contraception (see Appendix 3 for further details) for the duration of the trial and for four weeks after the last dose of trial drug. Women who are taking hormonal contraception must confirm stable formulation and dosage for at least 6 weeks prior to treatment
  • Alcohol consumption >21 units per week for men, and >14 units per week for women.
  • Positive urine drug screen at screening
  • Positive stool test for Clostridioides Difficile toxin or microscopy/culture positivity for enteric infection within twelve weeks prior to screening
  • Participation in an interventional trial, or use of a non-licensed investigational agent for any indication within twelve weeks before screening, or five half-lives of the investigational drug, whichever is longer
  • Newly introduced or a change in dosage of any of the following medications within twelve weeks of screening: fibric acid derivatives, farnesoid X-receptor agonists, anti-gastrointestinal motility agents (e.g., loperamide or opioids), bile acid sequestrants (e.g. colestyramine) or ursodeoxycholic acid (UDCA)
  • Use of any of the following medications within twelve weeks of screening: oral or intravenous antibiotics, including (but not limited to) vancomycin, rifaximin, rifampicin and metronidazole; probiotic or prebiotic preparations, including (but not limited to) VSL#3 and Symprove

Trial locations and contacts

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Helen Coulthard contact

+44 (0121) 3718198

FARGO@trials.bham.ac.uk

Anna Rowe contact

+44 (0121) 3718117

FARGO@trials.bham.ac.uk

5 sites in 1 country

United Kingdom5 sites, 5 recruiting

  • Queen Elizabeth Hospital Birmingham, University Hospitals Birmingham NHS Foundation Trust

    Birmingham, B15 2TH

    Palak Trivedi

    Recruiting

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

    London, NW10 7NS

    Ailsa Hart

    Recruiting

  • Royal Free Hospital, Royal Free London NHS Foundation Trust

    London, NW3 2QG

    Douglas Thorburn

    Recruiting

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

    London, SE5 9RS

    Deepak Joshi

    Recruiting

  • John Radcliffe Hospital, Oxford University Hospitals NHS Foundation Trust

    Oxford, OX3 9DU

    Emma Culver

    Recruiting

Other trials in United Kingdom

About this study

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

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.

Read the detailed description

Primary Sclerosing Cholangitis (PSC) is a chronic liver disease and there is no medical therapy proven to slow disease progression. Many patients with PSC also develop inflammatory bowel disease (IBD). It has been shown that there is an imbalance of 'normal' microbiome (e.g. bacteria, viruses, fungi) in the gut of people with PSC and IBD. This imbalance is believed to contribute to the development (and possibly worsening) of liver disease in PSC.

It is believed that Faecal Microbiota Transplant (FMT) treatment can restore the balance in the gut microbiome and that this can lead to reduction in symptoms of PSC and IBD and improve quality of life.

FMT involves the transplantation of faeces (or stool) from a healthy individual to a person with PSC. FMT is prepared from stool collected from unrelated, anonymous, healthy donors. The stool is treated in a laboratory at the University of Birmingham. The donors are carefully screened and the donated stool carefully tested to ensure that it is as clean and safe as possible before it is made into doses of FMT suitable for treatment purposes. Data from treatment with FMT in other conditions including Inflammatory Bowel Disease (IBD), Clostridioides difficile (C.diff) infection and PSC has shown FMT to be safe.

The primary aim of the FARGO trial is to determine the efficacy of FMT in patients with PSC. The FARGO trial will recruit 58 patients. Half will be randomised to FMT and half to placebo. The trial will be offered at a number of hospitals across England. Patients will be involved in the trial for 50 weeks, including a 2-week screening, 8 treatments over 8 weeks, and follow-up to 48 weeks post-randomisation. Trial visits will include the collection of health history, blood tests, stool tests, pregnancy tests (if applicable), medication reviews, disease specific measures, patient questionnaires and possible symptom and side-effect review. Research blood, urine, stool and colonic biopsy samples will also be collected.

Being tested
Faecal Microbiota Transplant, FMT Placebo
Medical subject headings
Cholangitis, Sclerosing, Inflammatory Bowel Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Faecal Microbiota TransplantBiological

    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

  • FMT PlaceboOther

    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

Study groups in NCT06286709
Study groupRoleWhat they receive
Faecal Microbiota Transplant (FMT)Active comparatorFMT 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
Receives: Biological: Faecal Microbiota Transplant
FMT PlaceboPlacebo comparatorFMT Placebo is 50mL aliquots of 0.9% w/v saline and glycerol in a ratio of 9 parts saline: 1 part glycerol v/v.
Receives: Other: FMT Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Serum Alkaline Phosphatase (ALP)

    Reduction in serum ALP values from baseline, measured at 48 weeks following the first dose of FMT or FMT Placebo.

    Measured: ALP at Screening (Week -2), Week 1, Week 3, Week 5, Week 8, Week 12, Week 24, Week 36 and Week 48

Secondary outcomes (19)

  1. Patient-reported outcome (PRO) measures

    Patient-reported outcome (PRO) measure: Primary Sclerosing Cholangitis -Patient Reported Outcome (PSC-PRO) Questionnaire

    Measured: PSC-PRO at Screening (Week -2), Week 8, Week 12, Week 24, Week 36 and Week 48

  2. Patient-reported outcome (PRO) measures

    Patient-reported outcome (PRO) measure: short-form (SF)-36 Questionnaire

    Measured: SF-36 at Screening (Week -2), Week 8, Week 12, Week 24, Week 36 and Week 48

  3. Patient-reported outcome (PRO) measures

    Patient-reported outcome (PRO) measures: 5 dimensional itch scale (5D itch) Questionnaire

    Measured: 5D-Itch at Screening (Week -2), Week 8, Week 12, Week 24, Week 36 and Week 48

  4. Patient-reported outcome (PRO) measures

    Patient-reported outcome (PRO) measures: Short Inflammatory Bowel Disease Questionnaire (SIBDQ)

    Measured: SIBDQ at Screening (Week -2), Week 8, Week 12, Week 24, Week 36 and Week 48

  5. Surrogate biomarkers of liver fibrosis

    Surrogate biomarkers of liver fibrosis: vibration-controlled transient elastography (VCTE)

    Measured: Surrogate biomarkers of liver fibrosis: VCTE at Screening (Week -2) and Week 48

  6. Surrogate biomarkers of liver fibrosis

    Surrogate biomarkers of liver fibrosis: enhanced liver fibrosis score (ELF)

    Measured: Surrogate biomarkers of liver fibrosis: ELF at Week 1, Week 5, Week 12, and Week 48

  7. Routine liver laboratory parameters

    Routine liver laboratory parameters: serum alanine transaminase (ALT)

    Measured: Routine liver laboratory parameters: ALT at Screening (Week -2), Week 1, Week 3, Week 5, Week 8, Week 12, Week 24, Week 36 and Week 48

  8. Routine liver laboratory parameters

    Routine liver laboratory parameters: serum aspartate aminotransferase (AST)

    Measured: Routine liver laboratory parameters: AST at Screening (Week -2), Week 1, Week 3, Week 5, Week 8, Week 12, Week 24, Week 36 and Week 48

  9. Routine liver laboratory parameters

    Routine liver laboratory parameters: bilirubin

    Measured: Routine liver laboratory parameters: bilirubin at Screening (Week -2), Week 1, Week 3, Week 5, Week 8, Week 12, Week 24, Week 36 and Week 48

  10. Routine liver laboratory parameters

    Routine liver laboratory parameters: gamma glutamyl transferase

    Measured: Routine liver laboratory parameters: gamma glutamyl transferase at Screening (Week -2), Week 1, Week 3, Week 5, Week 8, Week 12, Week 24, Week 36 and Week 48

  11. Routine liver laboratory parameters

    Routine liver laboratory parameters: albumin

    Measured: Routine liver laboratory parameters: albumin at Screening (Week -2), Week 1, Week 3, Week 5, Week 8, Week 12, Week 24, Week 36 and Week 48

  12. PSC specific prognostic scores

    PSC specific prognostic scores: the UK-PSC Score

    Measured: PSC specific prognostic scores: UK-PSC Score at Screening (Week -2), Week 1, Week 3, Week 5, Week 8, Week 12, Week 24, Week 36 and Week 48

  13. PSC specific prognostic scores

    PSC specific prognostic scores: the Amsterdam-Oxford PSC score

    Measured: PSC specific prognostic scores: Amsterdam-Oxford PSC Score at Screening (Week -2), Week 1, Week 3, Week 5, Week 8, Week 12, Week 24, Week 36 and Week 48

  14. Quantitative assessment of Inflammatory Bowel Disease (IBD) activity

    Quantitative assessment of IBD activity: The Mayo colitis score

    Measured: Quantitative assessment of IBD activity: Mayo colitis score at Week 1, Week 12 and Week 48

  15. Quantitative assessment of IBD activity

    Quantitative assessment of IBD activity: The Simple Endoscopic Score for Crohn's Disease (SES-CD);

    Measured: Quantitative assessment of IBD activity: SES-CD at Week 1, Week 12 and Week 48

  16. Quantitative assessment of IBD activity

    Quantitative assessment of IBD activity: faecal calprotectin

    Measured: Quantitative assessment of IBD activity: faecal calprotectin at Screening (Week -2), Week 1, Week 5, Week 12 and Week 48

  17. The incidence of clinical non-trial endpoint events

    The incidence of clinical non-trial endpoint events: acute cholangitis flares (including those that are resistant to single course antibiotic treatment), acute colitis flares, and episodes/time to hepatic decompensation

    Measured: The incidence of clinical non-trial endpoint events at Screening (Week -2), Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 12, Week 24, Week 36 and Week 48

  18. The incidence of trial endpoint events

    The incidence of trial endpoint events: cholangiocarcinoma / hepatopancreatobiliary malignancy, referral for liver transplantation, colonic resection or colorectal cancer, and/or mortality

    Measured: The incidence of trial endpoint events at Screening (Week -2), Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 12, Week 24, Week 36 and Week 48

  19. Occurrence of adverse events

    Occurrence of adverse events as measured by CTCAE v5.0

    Measured: Occurrence of adverse events at Screening (Week -2), Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 12, Week 24, Week 36 and Week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Feb 2024
  2. Study start27 Mar 2024
  3. Primary completion30 Sep 2027 (estimated)
  4. Study completion30 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Phase IIa, multi-centre, randomised, placebo-controlled, single-blinded, parallel group, clinical trial
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
58 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06286709
Sponsor's protocol ID
RG_22-063
Acronym
FARGO
Status last verified
Apr 2026
First submitted
7 Feb 2024
Last updated
24 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Anonymised patient level data may be shared in accordance with the Cancer Research UK Clinical Trials Unit (CRCTU) Data Sharing Policy. More detailed information on the CRCTU's Data Sharing Policy and the mechanism for obtaining data can be found on the CRCTU website: https://www.birmingham.ac.uk/research/crctu/data-sharing-policy

Publications

  • Al-Shakhshir S, Quraishi MN, Mullish B, Patel A, Vince A, Rowe A, Homer V, Jackson N, Gyimah D, Shabir S, Manzoor S, Cooney R, Alrubaiy L, Quince C, van Schaik W, Hares M, Beggs AD, Efstathiou E, Rimmer P, Weston C, Iqbal T, Trivedi PJ. FAecal micRobiota transplantation in primary sclerosinG chOlangitis (FARGO): study protocol for a randomised, multicentre, phase IIa, placebo-controlled trial. BMJ Open. 2025 Jan 6;15(1):e095392. doi: 10.1136/bmjopen-2024-095392.

    PubMed 39762111

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Faecal Microbiota Transplant in people with Primary Sclerosing Cholangitis and Inflammatory Bowel Diseases, run by University of Birmingham at 5 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Helen Coulthard (+44 (0121) 3718198, FARGO@trials.bham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serum Alkaline Phosphatase (ALP) (time frame: ALP at Screening (Week -2), Week 1, Week 3, Week 5, Week 8, Week 12, Week 24, Week 36 and Week 48). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06286709, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.

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