Synbiotics and Fecal Microbiota Transplantation to Treat Non-Alcoholic Steatohepatitis (SYNCH)
Non Alcoholic Steatohepatitis, Non-Alcoholic Fatty Liver Disease, Fecal Microbiota Transplantation
About this trial
This is an interventional treatment trial for Non Alcoholic Steatohepatitis
Eligibility Criteria
Inclusion Criteria: biopsy-proven NASH obtained up to 32 weeks before screening: SAF Steatosis score ≥1, Activity ≥2, Fibrosis <4; 50% of participants should at least have NASH fibrosis stage 1, 2 or 3 according to the NASH CRN fibrosis staging system based on tandem reading of two expert liver pathologists fluency in Dutch or English participants should be able to understand the information and give informed consent Exclusion Criteria: Current or history of significant alcohol consumption for a period of more than 3 consecutive months within 1 year before screening (significant alcohol consumption is defined as more than 2 international units/day for females and more than 3 international units/day for males, on average; 1 international unit contains ±14 grams of alcohol) liver cirrhosis or hepatocellular carcinoma hepatitis B and/or C auto-immune hepatitis Wilson's disease primary sclerosing cholangitis primary biliary cholangitis alpha-1-antitripsine deficiency and hemochromatosis history of liver transplant, current placement on a liver transplant list use of pre-, pro- or synbiotics use of systemic antibiotics 3 month prior to randomization use of tamoxifen, methotrexate or amiodarone prior or planned bariatric surgery active GLP-1 receptor agonist treated diabetes mellitus bleeding disorder International normalized ratio (INR) of prothrombin time >1.4 or platelet count <100 109/L at screening anti-platelet/coagulant therapy use which cannot be temporarily discontinued any major cardiovascular event within 6 months prior to screening (e.g. myocardial infarction, cerebrovascular accident) prolonged compromised immunity (e.g. recent cytotoxic chemotherapy, HIV-infection with a CD4 count < 240) active or prior history of invasive malignancy (except for curatively treated in situ carcinomas [e.g., cervix] or non-melanoma skin cancer) unless a complete remission was achieved surgery scheduled for the trial duration period, except for minor surgical procedures, in the opinion of the investigator pregnant or nursing women any condition which, in the investigator's opinion, might jeopardize participants' safety or compliance with the protocol participation in another concomitant clinical trial.
Sites / Locations
- Amsterdam UMCRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
LFMT-capsules
Placebo
LFMT-capsules. 3 times bulk, and further continuous administration. This arm is also treated pre- and probiotics.
Placebo-capsules. 3 times bulk, and further continuous administration. This arm is also treated pre- and probiotics.