Faecal Microbiota Transplantation for Liver Cirrhosis (CHiFT)
Liver Cirrhosis
About this trial
This is an interventional treatment trial for Liver Cirrhosis focused on measuring Hepatic encephalopathy, Ascites, Gastrointestinal bleeding, Spontaneous bacterial peritonitis, Hepatorenal syndrome, Alcoholic hepatitis
Eligibility Criteria
Inclusion Criteria:
- Age 18-75 years
- Liver cirrhosis with Child-Pugh score 7-12
- Hospital admission due to acute decompensation (ascites, gastrointestinal bleeding, bacterial infections, hepatic encephalopathy, alcoholic hepatitis)
- Maximum of 1 organ failure defined by CLIF-SOFA score
Exclusion Criteria:
- Untreated malignancy apart from hepatocellular carcinoma within the Milan criteria or non-melanoma skin cancer
- Untreated viral hepatitis
- HIV
- Inflammatory bowel disease
- Celiac disease
- Pregnancy
- Unable to participate based on medical judgement
Sites / Locations
- Department of Hepatology and Gastroenterology, Aarhus University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Faecal microbiota transplantation
Placebo
The patients will receive three applications of FMT consisting of 50 g cryopreserved, homogenized faeces from healthy donors. The faecal material will be dispensed into double-coated, acid-resistant enterocapsules or cryobags. Faeces will be screened according to international guidelines.
The placebo products is produced from a suspension of glycerol, saline and food colouring and cannot be distinguished from the active FMT products.