N/A N=42 Randomized Triple-blind Treatment

Rifaximin in Minimal Hepatic Encephalopathy

Hepatic Encephalopathy

Bottom Line

View on ClinicalTrials.gov: NCT00533910 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2020

Primary outcome: Primary: Driving Performance — 7.6; 5.5 raw number of driving errors

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Rifaximin (Drug); placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Hunter Holmes Mcguire Veteran Affairs Medical Center
Primary completion: Apr 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Driving Performance	7.6; 5.5	—
SECONDARY Psychometric Test Performance	0.46; 1.19	—
SECONDARY Total Sickness Impact Profile Score	12; 10	—

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.

Eligibility Criteria

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 ( 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00533910). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.