Protective Immune Mechanisms in Alcoholic Hepatitis (AHIL)

April 28, 2021 updated by: University of Aarhus
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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

51

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8000
        • Department of Hepatology and gastroenterology V, Aarhus university hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients admitted to the Department of hepatology and gastroenterology V, Aarhus University hospital

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Alcoholic hepatitis
Patients with alcoholic hepatic; cases.
Healthy controls
Persons undergoing hepatic resection; controls.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IL-22 binding protein
Time Frame: at day 1 ( the day of diagnosis/arrival to the department)
This will be detected in hepatic biopsies taken at inclusion to the study.
at day 1 ( the day of diagnosis/arrival to the department)
IL-22 receptor
Time Frame: at day 1 ( the day of diagnosis/arrival to the department)
This will be detected in hepatic biopsies taken at inclusion to the study.
at day 1 ( the day of diagnosis/arrival to the department)
Signalling molecules and markers of hepatocyte destruction
Time Frame: 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.
at day 1, at day 7 and at day 90 after diagnosis.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Investigators

  • Principal Investigator: Sidsel Støy, Phd student, Department of Hepatology and Gastroenterology, Aarhus University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2013

Primary Completion (Actual)

April 20, 2018

Study Completion (Actual)

April 20, 2018

Study Registration Dates

First Submitted

June 25, 2013

First Submitted That Met QC Criteria

August 5, 2013

First Posted (Estimate)

August 7, 2013

Study Record Updates

Last Update Posted (Actual)

April 29, 2021

Last Update Submitted That Met QC Criteria

April 28, 2021

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AHIL
  • AUH (Other Identifier: Aarhus University Hospital)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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