A clinical trial to test whether treating patients with liver cirrhosis with capsules containing healthy stool bacteria or a dummy capsule (placebo) will reduce the time it takes to develop an infection resulting in hospital admissio

Phase 3

• Conditions: Infection in patients with cirrhosis; Infections and Infestations

• Registration Number: ISRCTN17863382
• Lead Sponsor: King's College Hospital NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-03-25
• Last Update Posted: 12 February 2024
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 300

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

1. 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 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.