Rifaximin in Minimal Hepatic Encephalopathy

Not Applicable

Completed

Brief Summary: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	Will be given placebo and follow the exact procedures as the experimental section
Drug	Rifaximin	-

Primary Outcome Measures

Name	Time	Method
Driving Performance	8 weeks	Total driving errors at the end of drug/placebo. Minimum is zero, maximum is not defined. Higher number indicates greater errors.

Secondary Outcome Measures

Name	Time	Method
Total Sickness Impact Profile Score	8 weeks	Total score ranging from 0 through \>100 at the end of drug/placebo. Higher score indicates worse QOL
Psychometric Test Performance	8 weeks	Z score of combined cognitive tests at end of rifaximin/placebo; higher scores indicate better psychometric test performance