Extract

TITLE Rifaximin in Fatty Liver Disease (RiFL) DESIGN Proof-of-principle, open-label, randomised, cross-over, controlled study HYPOTHESIS Reduction in gut flora by the antibiotic Rifaximin reduces hepatic inflammation in Non-Alcoholic Steatohepatitis (NASH). AIMS To provide proof-of-concept data on the therapeutic potential of gut flora modification in NASH OUTCOME MEASURES Primary: • Change in serum ALT from baseline by 25 IU/L or to within normal range after 6 weeks of therapy Secondary: - Change in intrahepatic triglyceride, estimated by in vivo proton magnetic resonance spectroscopy (1H MRS) - Change in hepatic insulin resistance, estimated by the hyperinsulinaemic euglycaemic clamp - Changes to the faecal bacterial microbiome assessed by faecal DNA pyrosequencing and fluorescent in-situ hybridisation (FISH) - Differences in urinary metabolic profiles as assessed by high-resolution proton nuclear magnetic resonance spectroscopy POPULATION Patients with biopsy-confirmed non-alcoholic steatohepatitis and persistently raised serum aminotransferase levels TREATMENT The non-absorbable antibiotic Rifaximin DURATION Study duration 18 months. Individual patients' participation 18 weeks, with clinical follow-up 3 months after the end of the study.

Inclusion criteria

• nonalcoholic fatty liver disease,NAFLD,Nonalcoholic steatohepatitis

Links

• nct
• ictrp