Rifaximin Use in Severe Alcoholic Hepatitis
Phase 3
- Conditions
- Severe Alcoholic Hepatitis
- Interventions
- Registration Number
- NCT02485106
- Lead Sponsor
- Saint Vincent's Hospital, Korea
- Brief Summary
This study aimed to investigate the effect of decontamination by rifaximin in severe alcoholic hepatitis patients. Patients who take corticosteroid or pentoxifylline will be randomly allocated to rifaximin group or control group.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 170
Inclusion Criteria
- Heavy alcohol drinking within 3 months (Over 40 g/day)
- Maddrey's discriminant function ≥ 32
- AST/ALT ration ≥ 2
- Bilirubin level ≥ 5mg/dL
- Any one of the following additional criteria : hepatic encephalopathy, enlarged, tender liver, or peripheral leucocytosis
- Age : 19-75
- Jaundice within 3 months
Exclusion Criteria
- Other causes of chronic liver disease (HBV, HCV, or autoimmune hepatitis)
- Antibiotics or probiotics use within 8 weeks
- Drug induced hepatotoxicity
- Acute viral hepatitis (HAV or HEV)
- Hepatic abscess or cholagitis
- Hepatocellular carcinoma of modified UICC stage II, III or IV
- Malignant tumor other than HCC
- Pregnancy
- Severe chronic extrahepatic disease
- Type I hepatorenal syndrome
- Hepatic encephalopathy grade II or IV
- Severe infection
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group Corticosteroid or pentoxifylline Corticosteroid or Pentoxifylline for 28 days Rifaximin group Corticosteroid or pentoxifylline Corticosteroid or Pentoxifylline for 28 days Rifaximin 400mg tid for 28 days Rifaximin group Rifaximin Corticosteroid or Pentoxifylline for 28 days Rifaximin 400mg tid for 28 days
- Primary Outcome Measures
Name Time Method Mortality 6-month
- Secondary Outcome Measures
Name Time Method