Covert Hepatic Encephalopathy
Conditions
Keywords
covert hepatic encephalopathy, low-dose rifaximin
Brief summary
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.
Interventions
DRUGRifaximin
The investigators use low-dose rifaximin for the treatment of patients with covert hepatic encephalopathy
Sponsors
Shanghai Changzheng Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Patients agreed to sign the informed consents 2. Patients aged 18-70 years，males or females 3. Patients who were diagnosed with occult hepatic encephalopathy by PHES and Stroop tests
Exclusion criteria
1. Allergy to rifamycin/rifamutin/rifampin/rifapentine 2. Current or recent (\<3 month) use of alcohol or can't stop drinking during the study period 3. Use of antibiotics within last 6 weeks 4. Use of lactulose/lactitol, probiotics, L-ornithine-L-aspart，zinc，metronidazole, neomycin, or rifaximin within last 6 weeks 5. Infection or gastrointestinal hemorrhage within last 6 weeks 6. Use of psychoactive drugs within last 6 weeks 7. Occurred overt hepatic encephalopathy within last 3 months 8. history of portosystemic shunt surgery or transjugular intrahepatic portosystemic shunt 9. Poor vision, color blindness or motor defects that interfere with the performance of psychometric tests 10. Other non-controllable neurological or psychiatric problems which may affect cognitive function such as Alzheimer's disease, Parkinson's disease or schizophrenia 11. Conformed or highly suspicious diagnosis of liver malignant tumors 12. Human immunodeficiency virus (HIV) infection 13. Uncontrolled hypertension, diabetes or other serious cardiac and pulmonary diseases 14. White blood cell count\<1×10\^9/L 15. Pregnancy and breastfeeding 16. Participated in other drug clinical trials within 3 months 17. The researchers thought it was not suitable for this clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients showing covert hepatic encephalopathy reversal | up to 6 months | the percentage of patients showing covert hepatic encephalopathy reversal |
| health-related quality of life improvement | up to 6 month | complete the questionnaire sickness impact profile |
Countries
China
Outcome results
None listed