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Protective Immune Mechanisms in Alcoholic Hepatitis (AHIL)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2016 by University of Aarhus
Information provided by (Responsible Party):
University of Aarhus Identifier:
First received: June 25, 2013
Last updated: February 24, 2016
Last verified: February 2016
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.

Alcoholic Hepatitis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Protective Immune Mechanisms in Alcoholic Hepatitis

Resource links provided by NLM:

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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.

  • 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.

  • 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.

Biospecimen Retention:   Samples With DNA
Whole blood, serum, plasma, PBMC's, hepatic leukocytes

Estimated Enrollment: 60
Study Start Date: April 2013
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Alcoholic hepatitis
Patients with alcoholic hepatic; cases.
Healthy controls
Persons undergoing hepatic resection; controls.

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.

Ages Eligible for Study:   18 Years to 69 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients admitted to the Department of hepatology and gastroenterology V, Aarhus University hospital

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01918462

Contact: Sidsel Støy 004578463897

Department of Hepatology and gastroenterology V, Aarhus university hospital Recruiting
Aarhus, Denmark, 8000
Contact: Sidsel Støy, Phd Student    004578464087   
Sponsors and Collaborators
University of Aarhus
Principal Investigator: Sidsel Støy, Phd student Department of hepatology and gastroenterology, Aarhus University Hospital
  More Information

Responsible Party: University of Aarhus Identifier: NCT01918462     History of Changes
Other Study ID Numbers: AHIL
AUH ( Other Identifier: Aarhus University hospital )
Study First Received: June 25, 2013
Last Updated: February 24, 2016

Keywords provided by University of Aarhus:
Alcoholic hepatitis
Kupffer cells

Additional relevant MeSH terms:
Hepatitis, Alcoholic
Hepatitis A
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Liver Diseases, Alcoholic
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders processed this record on May 25, 2017