Phenotypical and Pathophysiological Characterization of Patients with Alcohol-related Liver Disease.

Completed

Conditions: alcohol use disorder
alcoholic liver disease
10019654

Registration Number: NL-OMON49648

Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 191

Inclusion Criteria

- diagnosis of ALD
- age>18 years old
- validation cohort:reliable self-reported alcohol use. The reliability of this
self-report will be based on (1) an interview by the researcher at study
inclusion, (2) an interview by the physician at inclusion.
- clinical application group: patients with ALD who deny moderate or excessive
alcohol intake in the last three months

Exclusion Criteria

- Other liver disease than ALD: more concrete: viral hepatitis, auto-immune
liver disease, hereditary hemochromatosis, Wilson's disease, cholestatic liver
diseases (primary biliary cholangitis, primary sclerosing cholangitis) en *1-
antitrypsine deficiency.
- unreliable self-reported alcohol use
- Pregnancy and breastfeeding
- Incompetent to understand and/or sign the informed consent
- Unwilling to provide biosamples

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To identify, develop and validate non-invasive biomarkers in blood, scalp hair,<br /><br>fingernails and urine for the assessment of alcohol use in patients with ALD<br /><br>with and without cirrhosis. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Identify the effect of liver cirrhosis and alcoholic liver disease on the<br /><br>diagnostic accuracy of non-invasive biomarkers for the assessment of alcohol<br /><br>use in patients with ALD.<br /><br>Identify, develop and validate future non-invasive biomarkers for the<br /><br>assessment of alcohol use in patients with ALD.<br /><br>To obtain body samples from patients with ALD for translational studies on the<br /><br>pathophysiology and treatment of ALD, with a focus on the gut-liver axis, this<br /><br>includes blood, exhaled air, urine, stools and optionally, when endoscopy is<br /><br>part of standard care, also intestinal biopsy samples</p><br>