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.