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This observational study explores the roles of fatty acids, genes, and gut microbiota in non-alcoholic fatty liver disease. Adults whose liver biopsy showed simple steatosis or NASH, or healthy control subjects with normal liver tests, were able to take part. It was conducted as a study with no assigned phase and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion criteria: * Male and female patients, age \>18 y * A liver biopsy with a diagnosis of SS or NASH OR No signs of steatosis, fibrosis or any other kind of liver disease on histology (minimal findings) OR For healthy control subjects, those with normal liver enzymes and normal liver imaging on ultrasound * alcohol consumption (\<20g of ethanol per day); * absence of any other possible cause for liver dysfunction. Exclusion criteria: * any other liver disease apart from NAFLD * anticipated need for liver transplantation in one year or complications of liver disease; * any reasons contraindicating a liver biopsy (patients) or liver donation (healthy donors) * chronic gastrointestinal diseases, previous gastrointestinal surgery modifying the anatomy, patients with diabetes requiring insulin. * medications known to precipitate steatohepatitis (corticosteroids, high dose estrogens, methotrexate, amiodarone, spironolactone, sulfasalazine, perhexiline maleate, diethylamino- ethoxyhexestrol (DH), tamoxifen, diethylstilbestrol, naproxen or oxacillin) or regular intake of non-steroidal anti-inflammatory drugs (except for low dose aspirin), use of ursodeoxycholic acid or any experimental drug in the 6 months prior to entry. * regular intake of prebiotics, probiotics, antibiotics, or laxatives; in the 3 months prior to study entry * Pregnant or lactating