Rifaximin Use in Severe Alcoholic Hepatitis

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Saint Vincent's Hospital, Korea
• Treatments: Pentoxifylline; Rifamycins; Rifaximin

Criteria

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