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

Prior treatment

• 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.

Other illness

• 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.

Other

• 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 \[1 unit of alcohol contains 10mLs or 8g of alcohol\]

• 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.