Alcohol Challenge On Liver and Gut Measured by Liver Vein Catheterization. A Pathophysiological Intervention Trial

Odense University Hospital

Status: Active, not recruiting

Conditions: Liver Fibroses; Alcohol-Induced Disorders

Treatments: Other: Ethanol

Study type: Interventional

Funder types: Other

Identifiers

NCT03018990

S-20160083

Details and patient eligibility

About

To investigate the effects of acute alcohol challenge on the gut and liver axis.

Full description

To study the role of acute alcohol challenge on the intestine permeability and inflow of bacterial products to the liver in participants with alcoholic liver disease, non-alcoholic steatohepatitis and healthy controls.

Enrollment: 40 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Alcoholic liver fibrosis, non-alcoholic steatohepatitis or liver-healthy individuals

And all of following:

• Bodymass > 50 kg
• Able to be fasting and abstinent on the day of intervention
• international ratio <1.5 and platelets >100 x 10^9, 7 days before the intervention day
• Informed consent

Exclusion criteria

• Antibiotics during the last 4 weeks
• Total alcohol abstinence
• Desire of total alcohol abstinence
• Other causes of liver disease suspected (viral, autoimmune, haemochromatosis, Wilsons diseases, alfa 1 antitrypsin deficiency or drug induced)
• Cirrhosis
• Insulin dependent diabetes mellitus
• Incapable to follow the protocol instructions
• Pregnancy
• Primary or secondary liver cancer
• Severe comorbidity
• Allergic to the contrast media iohexol

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 3 patient groups

Alcoholic liver fibrosis

Active Comparator group

Treatment:

Other: Ethanol

Non-alcoholic steatohepatitis

Active Comparator group

Treatment:

Other: Ethanol

Healthy control

Active Comparator group

Treatment:

Other: Ethanol