Clinical trial NCT00533910: Rifaximin in Minimal Hepatic Encephalopathy
Official 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatic Encephalopathy
Keywords: Minimal hepatic encephalopathy
Lead sponsor: Hunter Holmes Mcguire Veteran Affairs Medical Center
Sponsor class: FED
Collaborators: name: Bausch Health Americas, Inc.
First posted: 2007-09-24
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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 (\< 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

Primary outcomes:
measure: Driving Performance
timeFrame: 8 weeks
Secondary outcomes:
measure: Psychometric Test Performance
timeFrame: 8 weeks
measure: Total Sickness Impact Profile Score
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Hunter Holmes McGuire VA Medical Center
state: Virginia
Study officials:
affiliation: Medical College of Wisconsin
name: Jasmohan S Bajaj, MBBS, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bajaj JS, Heuman DM, Wade JB, Gibson DP, Saeian K, Wegelin JA, Hafeezullah M, Bell DE, Sterling RK, Stravitz RT, Fuchs M, Luketic V, Sanyal AJ. Rifaximin improves driving simulator performance in a randomized trial of patients with minimal hepatic encephalopathy. Gastroenterology. 2011 Feb;140(2):478-487.e1. doi: 10.1053/j.gastro.2010.08.061. Epub 2010 Sep 21.