Trial of faecal microbiota transplantation in cirrhosis

Not Applicable

Completed

• Conditions: Cirrhosis; Digestive System; Other and unspecified cirrhosis of liver

• Registration Number: ISRCTN11814003
• Lead Sponsor: King's College London and King's College Hospital

Brief Summary

2019 Protocol article in https://pubmed.ncbi.nlm.nih.gov/30772848/ (added 13/09/2021) 2020 Abstract results in https://doi.org/10.1016/S0168-8278(20)30687-5 Presented at EASL (added 29/06/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-05-21
• Study Completion: 2020-09-02
• Last Update Posted: 10 July 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

1. Aged 18–75 years
2. Confirmed advanced cirrhosis of any aetiology with a MELD score between 10 and 16. The diagnosis of liver cirrhosis will be based on clinical, radiological, or histological criteria
3. Patients with alcohol-related liver disease must have been abstinent from alcohol for a minimum of 6 weeks
4. Patients must be deemed to have capacity to consent to study (if patients lose capacity during the trial a legal representative will be appointed to act on their behalf)

Exclusion Criteria

1. Severe or life-threatening food allergy
2. Pregnancy or breastfeeding
3. Patients treated for active variceal bleeding, infection, overt hepatic encephalopathy, bacterial peritonitis or acute-on-chronic liver failure within the past 14 days
4. Patients who have received antibiotics in the past 14 days
5. Active alcohol consumption of >20 grams/day
6. Has had a previous liver transplant
7. Hepatocellular carcinoma outside of the Milan Criteria
8. Inflammatory bowel disease
9. Coeliac disease
10. A history of prior gastrointestinal resection such as gastric bypass
11. Patient is not expected to survive the duration of the study (90 days)
12. Severe renal impairment (creatinine >150 µmol/L)
13. HIV positive
14. Immunosuppression e.g. more than two weeks treatment with corticosteroids within 8 weeks of intervention, active treatment with tacrolimus, mycophenylate, azathioprine

Study & Design

• Study Type: Interventional
• Study Design: Not specified