search
Back to results

Rifaximin in Minimal Hepatic Encephalopathy

Primary Purpose

Hepatic Encephalopathy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Rifaximin
placebo
Sponsored by
Hunter Holmes Mcguire Veteran Affairs Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatic Encephalopathy focused on measuring Minimal hepatic encephalopathy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hunter Holmes McGuire VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Drug

Arm Description

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

Outcomes

Primary Outcome Measures

Driving Performance
Total driving errors at the end of drug/placebo. Minimum is zero, maximum is not defined. Higher number indicates greater errors.

Secondary Outcome Measures

Psychometric Test Performance
Z score of combined cognitive tests at end of rifaximin/placebo; higher scores indicate better psychometric test performance
Total Sickness Impact Profile Score
Total score ranging from 0 through >100 at the end of drug/placebo. Higher score indicates worse QOL

Full Information

First Posted
September 20, 2007
Last Updated
December 15, 2020
Sponsor
Hunter Holmes Mcguire Veteran Affairs Medical Center
Collaborators
Bausch Health Americas, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT00533910
Brief Title
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

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hunter Holmes Mcguire Veteran Affairs Medical Center
Collaborators
Bausch Health Americas, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Encephalopathy
Keywords
Minimal hepatic encephalopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Will be given placebo and follow the exact procedures as the experimental section
Arm Title
Drug
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Rifaximin
Intervention Description
550mg BID rifaximin for 8 weeks
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
same as the experimental arm
Primary Outcome Measure Information:
Title
Driving Performance
Description
Total driving errors at the end of drug/placebo. Minimum is zero, maximum is not defined. Higher number indicates greater errors.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Psychometric Test Performance
Description
Z score of combined cognitive tests at end of rifaximin/placebo; higher scores indicate better psychometric test performance
Time Frame
8 weeks
Title
Total Sickness Impact Profile Score
Description
Total score ranging from 0 through >100 at the end of drug/placebo. Higher score indicates worse QOL
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jasmohan S Bajaj, MBBS, MD, MS
Organizational Affiliation
Medical College of Wisconsin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hunter Holmes McGuire VA Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20849805
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.
Results Reference
result

Learn more about this trial

Rifaximin in Minimal Hepatic Encephalopathy

We'll reach out to this number within 24 hrs