Protective Immune Mechanisms in Alcoholic Hepatitis

N/ACompletedNCT01918462

University of Aarhus51 enrolled

Overview

The purpose of this study is to investigate the production, effects and interactions of the hepato-protective cytokine interleukine (IL)-22 in patients with alcoholic hepatitis.

The investigators will study hepatic biopsies from patients with alcoholic hepatitis. In these biopsies, the investigators will assess the production of IL-22 and which cells produce the cytokine. The investigators will study the expression of the IL-22 receptor and also the production of the IL-22 binding protein, which can inhibit the actions of the cytokine.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Alcoholic Hepatitis

Eligibility

Sex: ALLMin age: 18 YearsMax age: 69 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of alcoholic hepatitis: * relevant history of alcohol consumption (\>40g/day for a minimum of 6 months with cessation of consumption no earlier than 3 months prior to admission) * bilirubin \> 80 mol/l * neutrophil granulocytes \> 10x10\^9/L * exclusion of other liver pathology including biliary disease * histological verification on liver biopsy * Written, informed consent Exclusion Criteria: * Other chronic inflammatory or autoimmune diseases * Severe, acute bacterial infection (peritonitis, sepsis, pneumonia, urinary tract infection etc.) * Cancer * Prednisolon or pentoxifylline treatment within the past 8 weeks * Pregnancy

Locations (1)

Department of Hepatology and gastroenterology V, Aarhus university hospital

Aarhus, Denmark

Outcomes

Primary Outcomes

Frequency of IL-22-producing cells

This will be detected in hepatic biopsies taken at inclusion to the study.

Time frame: at day 1 ( the day of diagnosis/arrival to the department)

Secondary Outcomes

IL-22 binding protein

This will be detected in hepatic biopsies taken at inclusion to the study.

Time frame: at day 1 ( the day of diagnosis/arrival to the department)

IL-22 receptor

This will be detected in hepatic biopsies taken at inclusion to the study.

Time frame: at day 1 ( the day of diagnosis/arrival to the department)

Signalling molecules and markers of hepatocyte destruction

Thse measurements will be done on blood samples drawn at inclusion, at day 7 and at day 90 after diagnosis.

Time frame: at day 1, at day 7 and at day 90 after diagnosis.

Data from ClinicalTrials.gov

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