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RECRUITINGPhase 3INTERVENTIONAL

A PROspective Faecal MIcrobiota tranSplantation Trial to Improve outcomEs in Patients With Cirrhosis

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Aged ≥ 18 years 2. Confirmed Alcohol-related (ALD) or Metabolic dysfunction-Associated Steatotic Liver Disease (MASLD) or MetALD cirrhosis based on clinical, radiological and/or histological criteria. 3. MELD score 8-16 4. Patients with alcohol-related cirrhosis who must have an active alcohol consumption on average ≤20 grams/day \[1 unit of alcohol contains 10mLs or 8g of alcohol\]. 5. Patients must be deemed to have the capacity to provide written willing to sign a consent form to participate. Who Should NOT Join This Trial: 1. Moderate, severe or life-threatening food allergy (e.g., peanut allergy) 2. Pregnancy or planned pregnancy\*. Urine testing will be performed at screening to rule out pregnancy in females. 3. Breast-feeding 4. Patients treated for acute variceal bleeding, infection, overt hepatic encephalopathy, bacterial peritonitis or ACLF within 14 days prior to randomisation. 5. Active alcohol consumption of \>20 grams/day \[1 unit of alcohol contains 10mLs or 8g of alcohol\] 6. Had a previous liver transplant 7. Patients with inflammatory bowel disease. 8. Patients with coeliac disease. 9. 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 10. Active malignancy including hepatocellular carcinoma 11. Patients with an expected life expectancy \<6 months or listed for liver transplantation 12. Infected with HIV, hepatitis B or C \[patients who have undetectable hepatitis B or C DNA/RNA can be recruited\]. 13. 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. 14. Swallowing disorder, oral-motor dyscoordination or likely inability/unwillingness to ingest study medication. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Aged ≥ 18 years 2. Confirmed Alcohol-related (ALD) or Metabolic dysfunction-Associated Steatotic Liver Disease (MASLD) or MetALD cirrhosis based on clinical, radiological and/or histological criteria. 3. MELD score 8-16 4. Patients with alcohol-related cirrhosis who must have an active alcohol consumption on average ≤20 grams/day \[1 unit of alcohol contains 10mLs or 8g of alcohol\]. 5. Patients must be deemed to have the capacity to provide written informed consent to participate. Exclusion Criteria: 1. Moderate, severe or life-threatening food allergy (e.g., peanut allergy) 2. Pregnancy or planned pregnancy\*. Urine testing will be performed at screening to rule out pregnancy in females. 3. Breast-feeding 4. Patients treated for acute variceal bleeding, infection, overt hepatic encephalopathy, bacterial peritonitis or ACLF within 14 days prior to randomisation. 5. Active alcohol consumption of \>20 grams/day \[1 unit of alcohol contains 10mLs or 8g of alcohol\] 6. Had a previous liver transplant 7. Patients with inflammatory bowel disease. 8. Patients with coeliac disease. 9. 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 10. Active malignancy including hepatocellular carcinoma 11. Patients with an expected life expectancy \<6 months or listed for liver transplantation 12. Infected with HIV, hepatitis B or C \[patients who have undetectable hepatitis B or C DNA/RNA can be recruited\]. 13. 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. 14. Swallowing disorder, oral-motor dyscoordination or likely inability/unwillingness to ingest study medication. 15. Patients who have received another investigational drug or device within 4 months prior to randomisation. 16. 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.

Treatments Being Tested

DRUG

Encapsulated FMT

Encapsulated Faecal Microbiota Transplant

OTHER

Placebo

The placebo product contains microcrystalline methylcellulose. It is supplied as a size 0, Swedish Orange Delayed-Release capsule (DRCap) and provides a complete match with regards to the appearance (e.g., dimensions, colour) to the FMT capsules.

Locations (20)

Basildon University Hospital
Basildon, United Kingdom
Royal Bournemouth Hospital
Bournemouth, United Kingdom
Southmead Hospital
Bristol, United Kingdom
Bristol Royal Infirmary
Bristol, United Kingdom
Broomfield Hospital
Chelmsford, United Kingdom
Royal Derby Hospital
Derby, United Kingdom
Ninewells Hospital
Dundee, United Kingdom
Queen Elizabeth Hospital
Gateshead, United Kingdom
Glasgow Royal Infirmary
Glasgow, United Kingdom
Queen Elizabeth University Hospital
Glasgow, United Kingdom
University Hospital Hairmyres
Glasgow, United Kingdom
Hull Royal Infirmary
Hull, United Kingdom
Raigmore Hospital
Inverness, United Kingdom
St. James University Hospital
Leeds, United Kingdom
King's College Hospital NHS Foundation Trust
London, United Kingdom
St. George's University Hospital NHS Foundation Trust
London, United Kingdom
St. Mary's Hospital
London, United Kingdom
Freeman Hospital
Newcastle upon Tyne, United Kingdom
Royal Gwent Hospital
Newport, United Kingdom
Queen's Medical Centre
Nottingham, United Kingdom