Covert hepatic encephalopathy
Conditions
Interventions
Administer rifaximin 400 mg orally three times daily after meals.
No treatment
Sponsors
Kumamoto University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed with covert hepatic encephalopathy. However, even if it is not cirrhosis, patients with portal vein general circulation short circuit can participate. 2. Japan patients whose age at the time of obtaining consent is 20 years of age or older and under 75 years of age. 3. Patients who have received a thorough explanation of the content of their research and obtained their written consent. However, if the attending physician determines that it is difficult to obtain consent due to the lack of consent ability of the person who should be the subject, etc., the applicant may participate in this study by obtaining the written consent of the substitute in addition to the written consent of the subject himself/herself. 4. Patients who can be hospitalized or visited at the necessary time during the research period. 5. The presence or absence of administration of synthetic disaccharides is not required. 6. The level of ammonia in the blood does not matter.
Exclusion criteria
Exclusion criteria: 1. Patients with a mental illness (depression, mask depression, schizophrenia, dementia, etc.) 2. Patients diagnosed with malignant tumors and are undergoing treatment or untreated 3. Patients who have any of the following complications: Ascites requiring regular drainage Bleeding due to rupture of esophagus and gastric varicose veins Idiopathic bacterial peritonitis Severe electrolyte abnormalities that affect neuropsychiatric function 4. Patients with a history of hypersensitivity to rifaximin 5. Have serious complications listed below Patients with severe renal impairment or end-stage renal failure under dialysis Patients with uncontrolled conditions such as myocardial infarction, heart failure, angina pectoris, and arrhythmia 6. If a carnitine or zinc preparation is newly administered or the dose is changed between 4 weeks before the administration of rifaximin and 12 weeks after administration. 7. Pregnant women, lactating patients, and patients who may or intend to become pregnant 8. Patients with difficulty taking it orally 9. Other patients that the physician deems inappropriate to safely conduct this study 10. Patients with concomitant use of the following drugs (prohibited drugs: ethinylestradiol, cyclosporine). 11. Patients who have started antibiotics containing rifaximin or proton pump inhibitors within 12 weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| improvement of stroop test | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of overt hepatic encephalopathy Changes in ammonia levels Changes in NCT-B performance Overall survival / prognosis Alterations in gut microbiota composition Changes in L3 skeletal muscle mass Improvement in driving accidents, falls, and sleep disturbances associated with covert hepatic encephalopathy Safety assessment | — |
Countries
Japan
Contacts
Public ContactHiroki Inada
Kumamoto University Department of Gastroenterology and Hepatology, Graduate School of Medical Sciences.
Outcome results
None listed