Tests a capsule of gut bacteria in people with liver cirrhosis
Tests encapsulated faecal microbiota against placebo in adults with alcohol-related or MASLD cirrhosis.
Plain-language title generated from the registry record
Registry title: A PROspective Faecal MIcrobiota tranSplantation Trial to Improve outcomEs in Patients With Cirrhosis
Key facts
- Where
- Basildon, Bournemouth, Bristol, Chelmsford, Derby, Dundee, Gateshead, Glasgow, Hull, Inverness, Leeds, London, Newcastle upon Tyne, Newport, Nottingham, Plymouth, Southampton, and Torquay, United KingdomSee the 23 sites
- Phase
- Phase 3
Where in United Kingdom
- Basildon University HospitalBasildon, United KingdomTaking people
- Royal Bournemouth HospitalBournemouth, United KingdomTaking people
- Bristol Royal InfirmaryBristol, United KingdomTaking people
- Southmead HospitalBristol, United KingdomTaking people
- Broomfield HospitalChelmsford, United KingdomTaking people
- Royal Derby HospitalDerby, United KingdomTaking people
- Ninewells HospitalDundee, United KingdomTaking people
- Queen Elizabeth HospitalGateshead, United KingdomTaking people
- Glasgow Royal InfirmaryGlasgow, United KingdomTaking people
- Queen Elizabeth University HospitalGlasgow, United KingdomTaking people
- University Hospital HairmyresGlasgow, United KingdomTaking people
- Hull Royal InfirmaryHull, United KingdomTaking people
- Raigmore HospitalInverness, United KingdomTaking people
- St James University HospitalLeeds, United KingdomTaking people
- King's College Hospital NHS Foundation TrustLondon, United KingdomTaking people
- St Mary's HospitalLondon, United KingdomTaking people
- St. George's University Hospital NHS Foundation TrustLondon, United KingdomTaking people
- Freeman HospitalNewcastle upon Tyne, United KingdomTaking people
- Royal Gwent HospitalNewport, United KingdomNo longer taking part
- Queen'S Medical CentreNottingham, United KingdomTaking people
- Derriford HospitalPlymouth, United KingdomTaking people
- University Hospital SouthamptonSouthampton, United KingdomTaking people
- Torbay HospitalTorquay, United KingdomTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- King's College London
- Trial code
- NCT06461208
- Record updated
- 24 February 2026
- Original description
A feasibility trial called PROFIT has previously shown that FMT administered endoscopically into the jejunum in patients with cirrhosis is safe and feasible and have identified some potential mechanisms of action that warrant further interrogation. The aim of the PROMISE Trial is to evaluate the efficacy and mechanisms of action of encapsulated FMT (versus placebo) to reduce infection and mortality in patients with alcohol-related and metabolic dysfunction-Associated Steatotic Liver (MASLD) cirrhosis.Read full original descriptionShow less
PROMISE Trial: A PROspective Randomised Double-blind Parallel Group Placebo-controlled Multicentre Trial of Faecal MIcrobiota tranSplantation to Improve the Primary outcomE (First Hospitalisation Due to Infection) in Patients With Cirrhosis Over 24 Months
A feasibility trial called PROFIT has previously shown that FMT administered endoscopically into the jejunum in patients with cirrhosis is safe and feasible and have identified some potential mechanisms of action that warrant further interrogation. The aim of the PROMISE Trial is to evaluate the efficacy and mechanisms of action of encapsulated FMT (versus placebo) to reduce infection and mortality in patients with alcohol-related and metabolic dysfunction-Associated Steatotic Liver (MASLD) cirrhosis.
Inclusion: Aged ≥ 18 years; Confirmed Alcohol-related (ALD) or Metabolic dysfunction-Associated Steatotic Liver Disease (MASLD) or MetALD cirrhosis based on clinical, radiological and/or histological criteria; MELD score 8-16; Patients with alcohol-related cirrhosis who must have an active alcohol consumption on average ≤20 grams/day [1 unit of alcohol contains 10mLs or 8g of alcohol]; Patients must be deemed to have the capacity to provide written informed consent to participate.
Exclusion: Patients treated for acute variceal bleeding, infection, overt hepatic encephalopathy, bacterial peritonitis or ACLF within 14 days prior to randomisation; Had a previous liver transplant; Patients with a history of prior gastrointestinal resection or surgery that could change the gut microbiome or result in bacterial overgrowth e.g. gastric bypass; Patients with an expected life expectancy <6 months or listed for liver transplantation; Patients who have received antibiotics or probiotics (excluding food stuffs containing 'live bacteria' such as live yoghurts, kefir, fermented vegetables such as sauerkraut/kombucha or cheese) within 7 days prior to randomisation; Patients who have received another investigational drug or device within 4 months prior to randomisation; Moderate, severe or life-threatening food allergy (e.g., peanut allergy); Patients with inflammatory bowel disease; Patients with coeliac disease; Active malignancy including hepatocellular carcinoma; Infected with HIV, hepatitis B or C [patients who have undetectable hepatitis B or C DNA/RNA can be recruited]; Swallowing disorder, oral-motor dyscoordination or likely inability/unwillingness to ingest study medication; Patients, who in the opinion of the PI, have a medical condition, or other relevant psychological, familial, or social factor that may jeopardise their health, compliance, or influence the trial integrity in any way; Pregnancy or planned pregnancy*. Urine testing will be performed at screening to rule out pregnancy in females; Breast-feeding; Active alcohol consumption of >20 grams/day [1 unit of alcohol contains 10mLs or 8g of alcohol].