liver cirrhosis
Conditions
Interventions
control group:conventional therapy
low-dose rifaximin treatment group:rifaximin with the dose of 600mg/d (600mg, qd) for 24 weeks
conventional dose rifaximin treatment group:rifaximin 1200mg/d (600mg, bid) for 24 weeks
Sponsors
Shanghai East Hospital, Tongji University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Willing to sign informed consent; 2. Aged 18-80 years, no gender limit; 3. Cirrhosis confirmed by clinical, laboratory, imaging and/or liver biopsy; 4. The degree of cirrhosis is decompensated (decompensated cirrhosis is defined as at least one of the serious complications such as esophageal and gastric varices rupture and bleeding, hepatic encephalopathy, ascites, spontaneous bacterial peritonitis, etc.).
Exclusion criteria
Exclusion criteria: 1. Severe complications such as esophageal and gastric varices rupture and hemorrhage, hepatic encephalopathy, refractory ascites, hepatorenal syndrome or spontaneous bacterial peritonitis occurred within 4 weeks; 2. Uncontrolled severe infection or use of antibiotics within 2 weeks; 3. HBV-DNA>= lower limit of detection value in hepatitis B patients; If anti-hepatitis B drugs have been used for less than 12 months, or antiviral therapy may be discontinued during the study; 4. Those receiving anti-HCV treatment or receiving anti-HCV treatment in the 12 months prior to enrollment; 5. Patients with autoimmune liver disease who have received ursodeoxycholic acid, hormone or other immunosuppressant therapy, the dose stabilization time is =40g/ day for men and >=20g/ day for women); 7. Patients with confirmed or suspected malignant tumors (except those who have been cured for more than 5 years); 8. Patients with severe jaundice (serum TBil level >=85µmol/L) or obvious renal insufficiency (serum Cr>=1.2 ULN); 9. Severe electrolyte abnormalities (blood Na < 125 mmol/L) or life-threatening leukopenia (WBC < 1×10^9/L); 10. Patients with poorly controlled hypertension, diabetes or other serious heart and lung diseases (NYHA ?/? for cardiac insufficiency, GOLD C or above for chronic obstructive pulmonary disease); 11. Patients who use drugs, are on methadone treatment, are dependent on drugs or suffer from mental illness; 12. Patients infected with HIV; 13. Known allergy to rifaximin; 14. Pregnant and lactating patients or patients whose pregnancy is not ruled out; 15. Patients who have participated in other drug trials within 12 weeks; 16. The researchers did not consider it appropriate to participate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of overall complications resulting from decompensated liver cirrhosis; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of various complications of liver cirrhosis;All-cause mortality;Complication-free survival time;Liver transplantation free survival time;Incidence of overall complications resulting from decompensated liver cirrhosis;Liver function; | — |
Countries
China
Contacts
Public ContactZeng Xin
Department of Gastroenterology, Shanghai East Hospital, Tongji University School of Medicine
Outcome results
None listed