Infection and decompensation in patients with cirrhosis Infections and Infestations
Conditions
Interventions
Randomisation:
Patients will be randomised on a 1:1 basis to either FMT or placebo using the King's Clinical Trial Unit (KCTU) web-based randomisation system. Randomisation will be at the level of the
Sponsors
King's College Hospital NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
18 Years to 120 Years
Inclusion criteria
Inclusion criteria: Current key inclusion criteria as of 13/02/2026: 1. Age 18 years or over 2. Confirmed alcohol-related cirrhosis (ALD) or Metabolic dysfunction-Associated Steatotic Liver Disease (MASLD) or MetALD cirrhosis based on clinical, radiological and/or histological criteria 3. Model For End-Stage Liver Disease (MELD) score 8-16 4. Patients with alcohol-related cirrhosis who must have an active alcohol consumption on average =20 grams/day. 5. Patients must be deemed to have the capacity to consent _____ Previous key inclusion criteria: 1. Age 18 years or over 2. Confirmed alcohol-related cirrhosis or metabolic-associated fatty liver (MAFLD) cirrhosis based on clinical, radiological and/or histological criteria 3. Model For End-Stage Liver Disease (MELD) score 8-16 4. Patients with alcohol-related cirrhosis must have been abstinent for a minimum of 4 weeks prior to randomisation 5. Patients must be deemed to have the capacity to consent (if patients lose capacity during the trial a legal representative will be appointed on their behalf)
Exclusion criteria
Exclusion criteria: Current key exclusion criteria as of 13/02/2026: 1. Moderate, severe or life-threatening food allergy (e.g., peanut allergy) 2. Pregnancy or planned pregnancy. Urine testing will be performed at randomisation to rule out pregnancy in females 3. Breastfeeding 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 g/day (1 unit of alcohol contains 10 ml or 8 g 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 20 g/day (1 unit of alcohol contains 10 ml or 8 g 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 such as 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 foodstuffs 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome(s) as of 13/02/2026: 1. Time to first infection resulting in presentation to the Emergency Department (ED) or admission into hospital with a confirmed infection 2. Decompensating episodes as defined in the criteria below: a. Resulting in presentation to the Emergency Department b. Resulting in hospital admission When the patients meet the primary endpoint, they do not receive further IMP or attend trial visits, but they will continue to be enrolled in the trial for the purposes of monitoring of other clinical endpoints, e.g. all-cause mortality and liver-related mortality. _____ Previous primary outcome(s): Time to the first infection resulting in hospital admission i.e., the date the patient is admitted to the hospital due to infection, collected using the King's Clinical Trials Unit Index Hospitalisation (Primary Endpoint) form administered by the research nurse at each clinic visit i.e, 3, 6, 9, 12, 15, 18, 21 and 24 months. When the patients meet the primary endpoint, they do not receive further IMP or attend trial visits, but they will continue to be enrolled in the trial for the purposes of monitoring of other clinical endpoints, e.g. all-cause mortality and liver-related mortality. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current key secondary outcome(s) as of 13/02/2026: 1. Time to first infection resulting in hospitalisation over 24 month follow up period (former primary endpoint). 2. Incidence of decompensating events including hepatic encephalopathy, new-onset or worsening ascites or variceal bleeding over 24 month follow up period. 3. Incidence of all-cause infection over 24 month follow up period, including infections not resulting in hospitalisation. 4. Progression to ACLF (the development of one or more extrahepatic organ failures) 5. Infection rates and antibiotic usage following randomisation over 24 month follow up period. 6. Incidence of antimicrobial resistance (AMR) including skin and nose colonisation with methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant Enterococci (VRE), extended-spectrum beta-lactamase-producing bacteria (ESBL), fluoroquinolone-resistant Gram-negative and carbapenem-resistant Enterobacteriales (over 24 month follow up period). 7. Hospitalisation rates (liver-related and all-cause), including the length of stay and admission to high dependency/intensive care (over 24 month follow up period). 8. Change in liver disease severity scores at 3-, 6-, 12- and 24-months post randomisation. 9. Change in quality of life (EQ-5D-5L score) at 3, 6, 12 and 24 months post-randomisation 10. All-cause mortality and liver-related mortality 11. Change in depression and anxiety scores using HADS at 3, 6, 12 and 24-months post-randomisation 12. Change in alcohol use disorder-related events in patients enrolled with alcohol-related cirrhosis as assessed by the alcohol-use disorders identification test (AUDIT score) at 3, 6, 12 and 24 months post randomisation, and urinary ethyl glucuronide/ethyl sulphate levels if tested as part of the standard of care. 13. Safety of FMT based on safety assessments including physical examination, clinical laboratory evaluation, vital signs and reported as adverse events (AEs) or serious adverse events (SAEs) | — |
Countries
England, Scotland, United Kingdom
Contacts
Public ContactSue Cheung
Outcome results
None listed