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FARGO recruiting soon

Evaluating FAecal Microbiota Transplantation in PSC

FARGO-clinical-trial-for-psc

Thinking of taking part?

  1. Check how suitable you are by looking at the information below.
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  3. Contact the research team for more details if you think you are suitable. Check back regularly as we are adding more contact info every day.
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About FARGO

FARGO is a clinical trial that is jointly funded by the two charitable organisations, LifeArc and PSC Support. It is led by Dr Palak Trivedi, from the University of Birmingham, with support from PSC Support and hospitals/ academic institutions from around the UK.

This research would not be possible without the significant contributions of £848,774 from LifeArc and £50,000 from PSC Support.

About FMT

It has been shown that the makeup of gut microorganisms in PSC are different to that found in people without liver and bowel inflammation, and that this is one of the drivers of PSC development.

Dr Trivedi and his research team will assess a potential treatment for PSC called FMT (‘faecal microbiota transplantation’) that is thought to restore this abnormal gut bacteria balance. FMT involves taking stool from the gut of healthy donors, treating it in a laboratory and transferring it to the bowel of people with PSC.

Early research has shown that FMT is safe, is effective in treating inflammatory bowel disease and improves liver blood test results in some individuals.

The grant from LifeArc and PSC Support is allowing Dr Trivedi’s team to accelerate and scale up their research to understand the impact of FMT on PSC in this clinical trial.

FAQs

Key information

 

Trial Name FARGO

A randomised, phase IIa, multi-centre, placebo-controlled trial of FAecal microbiota transplantation in primaRy sclerosinG chOlangitis

ClinicalTrials.gov Identifier tbc
Phase Phase 2a trial
Intervention Faecal Microbiota Transplant (FMT) – administered via colonoscopy/enema
Recruiting now? Anticipated start February/March 2024
Participating Centres See PSC Support map, the current sites list on Clinicaltrials.gov and UK-PSC for up-to-date status for each centre.

  1. Queen Elizabeth Hospital (University Hospitals Birmingham NHS Foundation Trust); Principal Investigator: Dr Palak Trivedi
  2. Norfolk and Norwich University Hospital (Norfolk and Norwich University Hospitals NHS Foundation Trust); Principal Investigator: Dr Simon Rushbrook
  3. St Mark’s Hospital (London North West University Healthcare NHS Trust); Principal Investigator: Prof Ailsa Hart
  4. King’s College Hospital, London (King's College Hospital NHS Foundation Trust); Principal Investigator: Dr Deepak Joshi
  5. John Radcliffe Hospital (Oxford University Hospitals NHS Foundation Trust); Principal Investigator: Dr Emma Culver
  6. Royal Free Hospital, London (Royal Free London NHS Foundation Trust); Principal Investigator: Prof Douglas Thorburn
Contact Email: FARGO@trials.bham.ac.uk or Dr Palak Trivedi (Palak.trivedi@uhb.nhs.uk)
Liver disease diagnosis Primary sclerosing cholangitis (PSC)
Age You must be an adult (18 years and above)
Females: can I be pregnant or breastfeeding? No
Is IBD allowed? Yes
Is there an ALP (alkaline phosphatase) requirement? ALP values above the upper limit of normal
Can I take UDCA (Urso)? Yes, if on a stable dose of UDCA for at least 12 weeks prior to screening
Can I take biologics? Yes if on a stable dose for IBD for at least 12 weeks prior to screening
Can I take part if I have a stent? No
Are recent acute cholangitis (ie bacterial cholangitis) attacks allowed? No acute cholangitis attacks allowed for 12 weeks prior to screening
Can I take part if I have had a liver transplant? No
Is cirrhosis allowed? No
Previous studies and information
  • FARGO clinical trial funded by LifeArc and PSC Support
  • Allegretti JR, Kassam Z, Carrellas M, Mullish BH, Marchesi JR, Pechlivanis A, Smith M, Gerardin Y, Timberlake S, Pratt DS, Korzenik JR. Fecal microbiota transplantation in patients with primary sclerosing cholangitis: a pilot clinical trial. Official journal of the American College of Gastroenterology| ACG. 2019 Jul 1;114(7):1071-9 (download full text here)
Are travel expenses covered? Reasonable travel expenses covered (up to a maximum of £30 per treatment visit).
Procedures and tests include: Blood tests, stool tests, urine tests, health reviews, pregnancy test (women), Fibroscans, 2 colonoscopies a year apart (both of which will be your usual annual colonoscopies), one flexible sigmoidoscopy, and health-related quality of life questionnaires.
How many study visits will there be? How long will each study visit be? There is one hospital visit to check you are eligible to take part in the trial, then eight hospital appointments for the treatments, followed by 4 follow-up visits over the course of 12 months / a year.

  • Screening visit at hospital
  • Treatment visit 1 at hospital for treatment via colonoscopy + 6 hours’ monitoring (maximum, likely to be less).
  • Treatment visits 2-8 at hospital for treatment via enema + 1-2 hours’ monitoring maximum
  • Follow up visits x 4

More detailed information is available in the Participant Information Sheet.

Duration of study Screening period: 2 weeks, duration of treatment: 8 weeks; duration of follow up 40 weeks; TOTAL duration of trial: 50 weeks
Basic design of study Phase IIa, multi-centre, randomised, placebo-controlled, single-blinded, parallel group, clinical trial.
More information Participant Information sheet
Link to Sponsor University of Birmingham

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