Prospective randomised placebo controlled feasibility trial of faecal microbiota transplantation in cirrhosis

King's College London and King's College Hospital0 个研究点目标入组 23 人开始时间: 2018年5月21日最近更新: 2023年7月10日

适应症

试验速览

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)

•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)

•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

发起方

King's College London and King's College Hospital