Rifaximin in Minimal Hepatic Encephalopathy

Hunter Holmes Mcguire Veteran Affairs Medical Center

Status: Completed

Conditions: Hepatic Encephalopathy

Treatments: Drug: Rifaximin; Drug: placebo

Study type: Interventional

Funder types: Other U.S. Federal agency; Industry

Identifiers

NCT00533910

PRO00006863

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

42 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: placebo

Drug

Experimental group

Treatment:

Drug: Rifaximin