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

Not Applicable

Active, not recruiting

• Conditions: Alcohol-Induced Disorders; Liver Fibroses
• Interventions: Other: Ethanol

• Registration Number: NCT03018990
• Lead Sponsor: Odense University Hospital

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2016-11-09
• Study First Submitted: 2017-01-11
• Study First Submitted QC: 2017-01-11
• Study First Posted: 2017-01-12
• Primary Completion: 2018-11-12
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-06
• Last Update Posted: 2020-03-10
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-alcoholic steatohepatitis	Ethanol	-
Alcoholic liver fibrosis	Ethanol	-
Healthy control	Ethanol	-

Primary Outcome Measures

Name	Time	Method
changes in concentrations of bacterial products in the liver vein	Within 24 hours

Secondary Outcome Measures

Name	Time	Method
changes in the liver metabolome, transcriptome and proteome	Within 24 hours
changes in the gut microbiome	Within 24 hours
changes in serum-ethanol, plasma-glucose and liver biomarkers in the liver vein compared to the peripheral vein system	Within 24 hours
changes in concentrations of bacterial products in the peripheral vein system	Within 24 hours

Trial Locations

Locations (1)

Odense University Hospital; 🇩🇰 Odense, Fyn, Denmark