Rifaximin in Minimal Hepatic Encephalopathy
Rifaximin in Minimal Hepatic Encephalopathy
The purpose of this study is to determine whether alteration of gut flora with rifaximin can
 lead to improvement in driving performance, psychometric test performance, and quality of
 life in patients with minimal hepatic encephalopathy (MHE) and cirrhosis in a randomized,
 blinded, placebo-controlled trial.
Inclusion Criteria:

 -  Age 18-65 years

 -  Cirrhosis diagnosed on clinical grounds

 -  MHE diagnosed by abnormalities in a psychometric battery (NCT-A, NCT-B, ICT BDT and
 DST impaired beyond 2 standard deviations of known control values on any of the above
 3 tests will be considered to have MHE)

 -  Current drivers (valid driving license and driving at least 20 miles/week)

 -  All women of child-bearing potential will be required to use effective contraception

 Exclusion Criteria:

 -  Current or recent (< 6 month) use of alcohol (AUDIT questionnaire will be used; any
 cirrhotic with a value of > 0 will be excluded) and a positive blood alcohol level

 -  Use of antibiotics within last 6 weeks

 -  Allergy to rifaximin, rifabutin, rifampin, or rifapentine

 -  Infection or gastrointestinal hemorrhage within the last 6 weeks

 -  Renal insufficiency

 -  Hepatocellular carcinoma

 -  Psychoactive drug use, including interferon concurrently

 -  Non-drivers and those who drive less than 20 miles/week

 -  Pregnancy and breastfeeding

 -  Excluding patients with OHE:

 -  Detailed neurological examination to check for dysarthria, asterixis, ataxia and
 disorientation

 -  Detailed history-taking from friends/relatives only after taking the patient's
 permission

 -  Mini-mental status examination > 25

 -  Episode of overt (clinical hepatic encephalopathy) within 6 months

 -  Current treatment with lactulose, rifaximin, zinc, or metronidazole