CompletedNot Applicable

Rifaximin in Minimal Hepatic Encephalopathy

United States42 participantsStarted 2007-10

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Driving Performance

Timeframe: 8 weeks

Trial details

NCT IDNCT00533910

SponsorHunter Holmes Mcguire Veteran Affairs Medical Center

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2010-04

Results submitted2020-08-10

View on ClinicalTrials.gov More Hepatic Encephalopathy trials