Rifaximin in Minimal Hepatic Encephalopathy

Hunter Holmes Mcguire Veteran Affairs Medical Center42 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Hepatic Encephalopathy

Interventions

RifaximinDRUG

550mg BID rifaximin for 8 weeks

placeboDRUG

same as the experimental arm

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Hunter Holmes McGuire VA Medical Center

Richmond, Virginia, United States

Outcomes

Primary Outcomes

Driving Performance

Total driving errors at the end of drug/placebo. Minimum is zero, maximum is not defined. Higher number indicates greater errors.

Time frame: 8 weeks

Secondary Outcomes

Psychometric Test Performance

Z score of combined cognitive tests at end of rifaximin/placebo; higher scores indicate better psychometric test performance

Time frame: 8 weeks

Total Sickness Impact Profile Score

Total score ranging from 0 through \>100 at the end of drug/placebo. Higher score indicates worse QOL

Time frame: 8 weeks

Data from ClinicalTrials.gov

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