Liver cirrhosis
Conditions
Interventions
The study subjects will be orally administered 400 mg of rifaximin three times a day after each meal. The administration period will be 12 weeks.
Sponsors
Wakayama Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosed as liver cirrhosis (one of the following is recognized) 1) Diagnosed as liver cirrhosis by liver biopsy 2) Imaging findings typical of liver cirrhosis (irregularity of the liver surface, blunting of the margins, presence of uneven, coarse, or regenerated nodules in the liver parenchyma, findings of portal hypertension such as splenomegaly, dilatation of the splenic veins, and collateral blood vessels, and changes in the shape of the liver such as atrophy of the right lobe of the liver, atrophy of the medial zone of the liver, and enlargement of the lateral zone) 3) Typical endoscopic findings (esophagogastric varices, portal hypertensive gastropathy, etc.) 4) Platelet count of 150,000/mm3 or less 5) Vs measured by Virtual Touch Tissue Quantification (VTTQ) is 1.75 m/s or more, or Vs measured by Shear Wave Measurement (SWM) is 1.617 m/s or more. 6) APRI is greater than or equal to 1. 2. Hyperammonemia is present. 3. Without overt hepatic encephalopathy, and being diagnosed as covert hepatic encephalopathy by neuropsychiatric function tests (Number connection test-A, Number connection test-A or Stroop test) 4. Patients aged 40 years or older but less than 80 years at the time of consent. 5. Patient's written consent has been obtained.
Exclusion criteria
Exclusion criteria: 1. Patients who are not in a clear state of consciousness 2. Patients with psychiatric disorders (depression, masked depression, schizophrenia, dementia, etc.) 3. Patients with malignant tumors including hepatocellular carcinoma 4. Patients with any of the following complications 1) Ascites requiring periodic drainage 2) Bleeding due to rupture of esophageal or gastric varices 3) Spontaneous bacterial peritonitis 4) Severe electrolyte abnormalities that may affect neuropsychiatric function 5. Patients with a history of hypersensitivity to rifaximin 6. Patients with the following serious complications 1) Patients with severe renal dysfunction or end-stage renal failure on dialysis 2) Patients with poorly controlled myocardial infarction, heart failure, angina pectoris, arrhythmia, etc. 7. New administration or change in dosage of synthetic disaccharides, carnitine, zinc, or laxatives between 4 weeks before and 12 weeks after administration of rifaximin 8. Pregnant women, lactating women, and patients who may or intend to become pregnant 9. Patients who have difficulty in oral intake 10. Other patients who are deemed by the physician to be inappropriate for the safe conduct of this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The purpose of this study is to evaluate the efficacy of the Number connection test-A in improving liver cirrhosis with covert hepatic encephalopathy. Patients will be evaluated before, 4 weeks after, 8 weeks after, and 12 weeks after rifaximin administration. | — |
Countries
Japan
Contacts
Public ContactShiori Kaji
Wakayama Medical University Department of Gastroenterology
Outcome results
None listed