Using rifaximin to prevent complications in patients with liver cirrhosis
Rifaximin for Preventing Progression and Complications in Patients With Decompensated Liver Cirrhosis: a Multi-center Randomized Prospective Study
This study is testing if the antibiotic rifaximin can help prevent complications in people with liver cirrhosis by trying different doses over 24 weeks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Shanghai East Hospital Academic / other |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT05863364 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy and safety of rifaximin in preventing the progression and complications of decompensated liver cirrhosis. It is a multi-center, open-label, randomized prospective study involving 150 patients who will be divided into three groups: a control group and two treatment groups receiving low and conventional doses of rifaximin. The study aims to explore the appropriate dosage and potential mechanisms of rifaximin while maintaining other therapeutic strategies unchanged. The primary focus is on assessing the progression of cirrhosis and related complications over a 24-week period.
Who should consider this trial
Good fit: Ideal candidates for this study are patients diagnosed with decompensated liver cirrhosis who have experienced severe complications.
Not a fit: Patients with recent episodes of overt hepatic encephalopathy, variceal bleeding, or severe infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new preventative treatment option for patients with decompensated liver cirrhosis, potentially improving their survival and quality of life.
How similar studies have performed: While rifaximin has been used for hepatic encephalopathy and spontaneous bacterial peritonitis, this specific application for preventing progression in decompensated cirrhosis is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * With a clinical diagnosis of decompensated liver cirrhosis on the basis of typical clinical manifestations, laboratory tests, imaging appearances and/or representative pathology results of liver biopsy. Decompensation of the disease was defined by at least having an episode of severe complications, including ascites, SBP, EGVB and HE. Exclusion Criteria: * Episodes of overt HE, EGVB or SBP within 4 weeks before the screening visit * Uncontrolled severe infection or antibiotic use within 2 weeks before the screening visit * Hepatitis B virus (HBV) DNA ≥ 500 copy/mL，or receipt of standard antiviral treatment for hepatitis B for less than 12 months * Receiving antiviral treatment for hepatitis C or receipt of antiviral treatment for hepatitis C within 12 months before the screening visit * If patients with autoimmune liver disease have been treated with ursodeoxycholic acid, hormone or other immunosuppressants, the dose stability time is less than 6 months * With history of alcoholism in the last 12 weeks or unwilling to stop alcohol abuse after inclusion (≥ 20 g/day for women or ≥ 30 g/day for men) * With confirmed or suspected malignancies * Severe jaundice (serum total bilirubin level ≥ 85 μmol/L) * Obvious renal dysfunction (serum creatinine ≥ 1.2-fold of upper normal limits) * Severe electrolyte abnormality (serum sodium level \< 125 mmol/L ) * Life-threatening leucocytopenia (white blood cell count \< 1 × 10\^9/L ) * Poorly controlled hypertension, diabetes mellitus or other severe heart and respiratory diseases (NYHA Ⅲ/Ⅳ, COPD GOLD C) * With drug abuse, methadone treatment, drug dependence or mental illness * HIV seropositivity * Known to be allergic to rifaximin * Pregnant and lactating women or women who do not rule out pregnancy * Those who have participated in other drug trials within 12 weeks
Where this trial is running
Shanghai
- Shanghai East Hospital — Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Xin Zeng, Dr. — Department of Gastroenterology, Shanghai East Hospital, Tongji University School of Medicine
- Study coordinator: Xin Zeng, Dr.
- Email: zengxinmd1978@163.com
- Phone: 086018918353309
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.