Rifaximin in Minimal Hepatic Encephalopathy

NCT00533910 | Completed Results

• 1 other identifier: PRO00006863
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatic Encephalopathy

Keywords

Minimal hepatic encephalopathy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Psychometric Test Performance

  8 weeks

• Total Sickness Impact Profile Score

  8 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Drug: placebo

Drug

EXPERIMENTAL

Drug: Rifaximin

Interventions

Rifaximin DRUG

550mg BID rifaximin for 8 weeks

Drug

placebo DRUG

same as the experimental arm

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hunter Holmes Mcguire Veteran Affairs Medical Center: lead
• Bausch Health Americas, Inc.: collaborator

Study Sites (1)

Hunter Holmes McGuire VA Medical Center

Richmond, Virginia, 23249, United States

Location

Related Publications (2)

• 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.

  PMID: 20849805 RESULT

• 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.

  PMID: 37467180 DERIVED

MeSH Terms

Conditions

Hepatic Encephalopathy

Interventions

Rifaximin

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Jasmohan Bajaj
• Organization: Hunter Holmes McGuire VAMC

jasmohan@gmail.com

804 675 5802

Study Officials

• Jasmohan S Bajaj, MBBS, MD, MS

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: September 20, 2007
• First Posted: September 24, 2007
• Study Start: October 1, 2007
• Primary Completion: April 1, 2010
• Study Completion: May 1, 2010
• Last Updated: December 17, 2020
• Results First Posted: December 17, 2020

Record last verified: 2020-12

Locations

US (1)