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Completed

NCT Number: NCT00533910

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.

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Key information

Conditions

Hepatic Encephalopathy Brain Diseases Brain Diseases, Metabolic Central Nervous System Diseases Digestive System Diseases Hepatic Insufficiency Liver Diseases Liver Failure Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hunter Holmes McGuire VA Medical Center

Richmond, Virginia, 23249, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rifaximin

Drug

550mg BID rifaximin for 8 weeks

Placebo

Drug

same as the experimental arm

Primary outcomes

  1. Driving Performance

    Time frame: 8 weeks

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

Secondary outcomes

  1. Psychometric Test Performance

    Time frame: 8 weeks

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

  2. Total Sickness Impact Profile Score

    Time frame: 8 weeks

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

Sponsors and collaborators

Lead sponsor

Hunter Holmes Mcguire Veteran Affairs Medical Center

Fed

Collaborators

  • Bausch Health Americas, Inc.

Registry information

Official study title

Effect of Rifaximin on Driving Performance, Psychometric Test Performance and Quality of Life in Cirrhotic Patients With Minimal Hepatic Encephalopathy: Randomized, Double-blind, Placebo-controlled Trial.

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Sep 24, 2007
Registry last updated
Dec 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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