Rifaximin in Minimal Hepatic Encephalopathy

Hepatic Encephalopathy Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00533910
• Other study ID #: PRO00006863
• Status: Completed
• Phase: N/A
• Start date: October 2007
• Est. completion date: May 2010

Study information

• Verified date: December 2020
• Source: Hunter Holmes Mcguire Veteran Affairs Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: May 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Diseases
• Hepatic Encephalopathy

Intervention

Drug:
• Rifaximin
550mg BID rifaximin for 8 weeks
• placebo
same as the experimental arm

Locations

Country	Name	City	State
United States	Hunter Holmes McGuire VA Medical Center	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Hunter Holmes Mcguire Veteran Affairs Medical Center	Bausch Health Americas, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 encepha — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Driving Performance	Total driving errors at the end of drug/placebo. Minimum is zero, maximum is not defined. Higher number indicates greater errors.	8 weeks
Secondary	Psychometric Test Performance	Z score of combined cognitive tests at end of rifaximin/placebo; higher scores indicate better psychometric test performance	8 weeks
Secondary	Total Sickness Impact Profile Score	Total score ranging from 0 through >100 at the end of drug/placebo. Higher score indicates worse QOL	8 weeks