Low-dose Rifaximin in the Treatment of Covert Hepatic Encephalopathy

Study Overview
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Brief Summary
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Several studies have been showed that rifaximin can improve cognitive functions, driving simulator performance and health-related quality of life in patients with minimal hepatic encephalopathy. The aim of this prospective randomized open controlled study was to evaluate the efficacy and safety of rifaximin at different doses for the treatment of covert hepatic encephalopathy.

Official Title
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Low-dose Rifaximin in the Treatment of Covert Hepatic Encephalopathy: A Randomized Open Controlled Study

Conditions
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Covert Hepatic Encephalopathy

Intervention / Treatment
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* Drug: Rifaximin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients agreed to sign the informed consents Patients aged 18-70 years，males or females Patients who were diagnosed with occult hepatic encephalopathy by PHES and Stroop tests Exclusion Criteria: Allergy to rifamycin/rifamutin/rifampin/rifapentine Current or recent (<3 month) use of alcohol or can't stop drinking during the study period Use of antibiotics within last 6 weeks Use of lactulose/lactitol, probiotics, L-ornithine-L-aspart，zinc，metronidazole, neomycin, or rifaximin within last 6 weeks Infection or gastrointestinal hemorrhage within last 6 weeks Use of psychoactive drugs within last 6 weeks Occurred overt hepatic encephalopathy within last 3 months history of portosystemic shunt surgery or transjugular intrahepatic portosystemic shunt Poor vision, color blindness or motor defects that interfere with the performance of psychometric tests Other non-controllable neurological or psychiatric problems which may affect cognitive function such as Alzheimer's disease, Parkinson's disease or schizophrenia Conformed or highly suspicious diagnosis of liver malignant tumors Human immunodeficiency virus (HIV) infection Uncontrolled hypertension, diabetes or other serious cardiac and pulmonary diseases White blood cell count<1×10^9/L Pregnancy and breastfeeding Participated in other drug clinical trials within 3 months The researchers thought it was not suitable for this clinical trial

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: the high-dose rifaximin<br>The high-dose rifaximin group was given rifaximin 1200 mg/day for 8 weeks. | Drug: Rifaximin<br>* The investigators use low-dose rifaximin for the treatment of patients with covert hepatic encephalopathy<br>|
| Active Comparator: the low-dose rifaximinl group<br>The low-dose rifaximin group was given rifaximin 800 mg/day for 8 weeks. | Drug: Rifaximin<br>* The investigators use low-dose rifaximin for the treatment of patients with covert hepatic encephalopathy<br>|
| Placebo Comparator: the control group<br>The control group didn't receive rifaximin treatment | Drug: Rifaximin<br>* The investigators use low-dose rifaximin for the treatment of patients with covert hepatic encephalopathy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients showing covert hepatic encephalopathy reversal | the percentage of patients showing covert hepatic encephalopathy reversal | up to 6 months | 
| health-related quality of life improvement | complete the questionnaire sickness impact profile | up to 6 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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covert hepatic encephalopathy, low-dose rifaximin