Rifaximin in Fatty Liver Disease

Summary

TITLE Rifaximin in Fatty Liver Disease (RiFL) DESIGN Open-label pilot 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 Rifaximin 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 This was an open-label study of Rifaximin (Normix, Alfa Wasserman S.p.A, Bologna, Italy) 400mg twice daily for six weeks followed by a further six weeks observation period during which patients received standard care.

Timeline

Start

2011-05

Primary completion

2012-09

Completion

2012-09

Drugs

Indications