Rifaximin in Minimal Hepatic Encephalopathy

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.

Sponsors

Lead Sponsor: Hunter Holmes Mcguire Veteran Affairs Medical Center

Collaborator: Bausch Health Americas, Inc.

Source Hunter Holmes Mcguire Veteran Affairs Medical Center
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.

Overall Status Completed
Start Date 2007-10-01
Completion Date 2010-05-01
Primary Completion Date 2010-04-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Driving Performance 8 weeks
Secondary Outcome
Measure Time Frame
Psychometric Test Performance 8 weeks
Total Sickness Impact Profile Score 8 weeks
Enrollment 42
Condition
Intervention

Intervention Type: Drug

Intervention Name: Rifaximin

Description: 550mg BID rifaximin for 8 weeks

Arm Group Label: Drug

Intervention Type: Drug

Intervention Name: placebo

Description: same as the experimental arm

Arm Group Label: Placebo

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

65 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Jasmohan S Bajaj, MBBS, MD, MS Principal Investigator Medical College of Wisconsin
Location
Facility: Hunter Holmes McGuire VA Medical Center
Location Countries

United States

Verification Date

2020-12-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Hunter Holmes Mcguire Veteran Affairs Medical Center

Investigator Full Name: Jasmohan Bajaj

Investigator Title: Associate Professor of Medicine

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Placebo

Type: Placebo Comparator

Description: Will be given placebo and follow the exact procedures as the experimental section

Label: Drug

Type: Experimental

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Triple (Participant, Care Provider, Investigator)

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