Protective Immune Mechanisms in Alcoholic Hepatitis

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01918462

Acronym

AHIL

Enrollment

Registered

2013-08-07

Start date

2013-04-30

Completion date

2018-04-20

Last updated

2021-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcoholic Hepatitis

Keywords

Alcoholic hepatitis, IL-22, Kupffer cells

Brief summary

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.

Detailed description

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 69 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Frequency of IL-22-producing cells	at day 1 ( the day of diagnosis/arrival to the department)	This will be detected in hepatic biopsies taken at inclusion to the study.

Secondary

Measure	Time frame	Description
IL-22 binding protein	at day 1 ( the day of diagnosis/arrival to the department)	This will be detected in hepatic biopsies taken at inclusion to the study.
IL-22 receptor	at day 1 ( the day of diagnosis/arrival to the department)	This will be detected in hepatic biopsies taken at inclusion to the study.
Signalling molecules and markers of hepatocyte destruction	at day 1, at day 7 and at day 90 after diagnosis.	Thse measurements will be done on blood samples drawn at inclusion, at day 7 and at day 90 after diagnosis.

Countries

Denmark

Outcome results