A Study to Establish an Alcoholic Hepatitis Network

Overview

About this study

The purpose of this study is to create a clinical database and bio-repository by obtaining blood, urine, and stool samples (e.g., biological samples) and personal health information from patients to use in future research studies related to alcoholic hepatitis or other diseases.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Please contact the study team to discuss whether or not you are eligible to participate in a study.

CASES: Heavy drinkers with alcoholic hepatitis.

Inclusion Criteria:

  • A clinical diagnosis of alcoholic hepatitis.
  • Serum total bilirubin >3 mg/dL.
  • Subject or guardian ability to understand and willingness to provide written consent.
  • Age greater or equal to 21 years.
  • Re-enrolment of an alcoholic hepatitis donor is permissible up to 4 times if the donor presents with a new episode of alcoholic hepatitis 24 weeks or longer after the most recent enrolment in the study.

Exclusion Criteria:

  • Liver disease significantly caused by hemochromatosis, autoimmune liver disease, Wilson disease, NAFLD, and acute viral hepatitis.
    • NOTE: The presence of chronic hepatitis C, hepatitis B, or HIV is not exclusion to participation).
  • Pregnant or breast feeding.
  • Based on the judgment of the investigator, subject is not capable of understanding or complying with the study requirements.

CONTROLS: Heavy drinkers without significant liver disease Inclusion criteria

  • History of chronic alcohol consumption sufficient to cause liver damage. Generally, this is considered to be >40 g/day or >280g/week on average for women and >60 g/day or >420 g/week on average for men, for many years (usually decades). Judgement about chronic alcohol consumption will be made by the site investigator. 
  • Subject or guardian ability to understand and willingness to provide written consent.
  • Age greater or equal to 21 years.

Exclusion Criteria:

  • Past evidence of alcoholic liver disease, defined as a bilirubin > 2.0 mg/dL, an AST > 1.5 ULN, and any hospital admission for liver disease, or the presence of esophageal varices or ascites (at any time in the past).
  • Liver disease significantly caused by hemochromatosis, autoimmune liver disease, Wilson disease, NAFLD, and acute viral hepatitis.
    • NOTE: The presence of chronic hepatitis C, hepatitis B, or HIV is not exclusion to participation.
  • Alcohol intake at less than 40 g/day or 280g/week on average for women and 60 g/day or 420 g/week on average for men for longer than the past 28 days.
  • If liver stiffness has been assessed within the prior 90 days, then stiffness suggesting fibrosis of F1 or greater is excluded. For Fibroscan, this is a fibrosis score >7.0 kPa.
  • Pregnant or breast feeding.
  • Any of the following laboratory abnormalities within 90 days prior to signing the consent:
    • Total bilirubin: >ULN* 2.
    • INR: > 1.4 5
      • *Individuals with a diagnosis of Gilbert's can have total bilirubin up to 3.0 mg/dL and still be eligible for participation.

HEALTHY CONTROLS

Inclusion Criteria:

  • AUDIT-C scores of <4 for men and <3 for women (signifying no alcohol misuse).
  • Abstinent (consumption of less than one standard drink/week) during the 6 months prior to enrolment.
  • Ability to understand and willingness to provide written consent.

Exclusion Criteria:

  • Clinical history or laboratory evidence of liver disease including alcoholic liver disease, NAFLD, hemochromatosis, alcoholic hepatitis, autoimmune liver disease, Wilson disease, hepatitis C, or hepatitis B. 
  • Presence of diabetes (requiring treatment with oral agents or insulin). 
  • Significant heart disease (prior history of heart disease, other than hypertension).
  • Chronic lung disease (requiring chronic treatment).
  • Immune related conditions (such as Crohn's disease, rheumatoid arthritis, ulcerative colitis, systemic lupus erythematosus, severe psoriasis, etc.).
  • Known infection with HIV.
  • Presumed infection, or use of antibiotics or other medications (e.g., corticosteroids) that would affect immune function, within the past 14 days.
  • BMI>35.
  • Current or known history of cancer (except in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to enrollment.
  • Pregnant or breast feeding.
  • Any of the following laboratory abnormalities within 90 days prior to signing the consent:
    • Hemoglobin: <10 g/dL;
    • Conjugated bilirubin: > ULN;
    • INR: > 1.4;
    • AST: >40 IU/mL;
    • ALT: >40 IU/mL.
  • Based on the judgment of the investigator, subject is not capable of complying with the study requirements.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Vijay Shah, M.D.

Open for enrollment

Contact information:

Amy Olofson R.N.

(507)284-2638

Olofson.Amy@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available