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Rifaximin in Minimal Hepatic Encephalopathy

NCT ID: NCT00533910

Last Updated: 2020-12-17

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2010-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hepatic Encephalopathy

Keywords

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Minimal hepatic encephalopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Placebo

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

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

same as the experimental arm

Drug

Group Type EXPERIMENTAL

Rifaximin

Intervention Type DRUG

550mg BID rifaximin for 8 weeks

Interventions

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Rifaximin

550mg BID rifaximin for 8 weeks

Intervention Type DRUG

placebo

same as the experimental arm

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bausch Health Americas, Inc.

INDUSTRY

Sponsor Role collaborator

Hunter Holmes Mcguire Veteran Affairs Medical Center

FED

Sponsor Role lead

Responsible Party

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Jasmohan Bajaj

Associate Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jasmohan S Bajaj, MBBS, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Medical College of Wisconsin

Locations

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Hunter Holmes McGuire VA Medical Center

Richmond, Virginia, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 20849805 (View on PubMed)

Zacharias HD, Kamel F, Tan J, Kimer N, Gluud LL, Morgan MY. Rifaximin for prevention and treatment of hepatic encephalopathy in people with cirrhosis. Cochrane Database Syst Rev. 2023 Jul 19;7(7):CD011585. doi: 10.1002/14651858.CD011585.pub2.

Reference Type DERIVED
PMID: 37467180 (View on PubMed)

Other Identifiers

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PRO00006863

Identifier Type: -

Identifier Source: org_study_id