Effects of Rifaximin in Patients With Acute Alcoholic Hepatitis

• Status: Unknown status
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Acute alcoholic hepatitis (AAH) is a serious condition and one of the most frequent causes of Acute-on-Chronic Liver Failure. The current standard therapy (corticosteroids) is theme of debate and unsatisfactory in many patients (year mortality: 30%). One of the main causes of death is bacterial infections, which affect 40-50% of patients at 90 days. Intestinal decontamination with rifaximin (a nonabsorbable antibiotic) reduces endotoxemia, improves liver function and reduces the complications of decompensated alcoholic cirrhosis.

The Hypothesis/Objective: To assess whether oral decontamination with rifaximin prevents the development of infections associated with AAH and analyze its consequences.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute
• Collaborators: Germans Trias i Pujol Hospital; Hospital de Sant Pau; Hospital del Mar
• Treatments: Prednisone; Rifamycins; Rifaximin

Criteria

Inclusion Criteria:

• Patients ≥18 and <70 years of age.

• Active alcohol abuse and excessive alcohol consumption prior to admission defined as > 50 g per day for men and> 40 g per day for women.

• Jaundice (Bilirubin >2 mg/dl) for no more than 3 months.

• Clinical suspicion of Alcoholic Hepatitis with a modified Maddrey's Discriminant Function > 32 points.

Exclusion Criteria:

• Hypersensitivity to Rifaximin

• Advanced Chronic or Terminal illness. Advanced Chronic illness will be defined as: all conditions evolved into a clinical stage to limit the patient's functional status (eg, heart failure NYHA> II, COPD PCO2> 50 mmHg or PO2 <60 mmHg, stroke or other disabling neurological disease, disabling or uncontrolled oncological conditions, etc ...).

Terminal illness will be defined as any clinical conditions with a survival expectancy less than 3 months

• Hepatocellular carcinoma (previously diagnosed) beyond Milan's criteria.

• Complete portal vein thrombosis (previously diagnosed).

• Autoimmune liver disease.

• Hepatitis B and C and HIV infection (anti-HCV, surface HBV antigen and anti-HIV positive).

• Pregnancy or nursing.

• Use of Rifaximin during the previous 2 months.

• Treatment with Pentoxifylline.

• Lack of informed consent.

Removal criteria:

• Lack of histological confirmation of Alcoholic Hepatitis during the first 7 days after inclusion.

Because there are no non-diagnostic tools to diagnose alcoholic hepatitis, histological confirmation is required in all patients (preferably through a transjugular biopsy): alcoholic hepatitis will be diagnosed on the presence of the following histologic features:

Hepatocellular damage (eg, hepatocyte ballooning and presence of Mallory-Denk bodies).

Inflammatory infiltrate (predominantly polymorphonuclear cells). Pericellular or sinusoidal fibrosis.

• Hepatocellular carcinoma beyond Milan's criteria diagnosed during the first 7 days after inclusion.

• Complete portal vein thrombosis diagnosed during the first 7 days after inclusion.

• Protocol violation.

• Severe adverse event directly related with Rifaximin.