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

Liver Fibroses Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03018990
• Other study ID #: S-20160083
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 9, 2016
• Est. completion date: December 1, 2024

Study information

• Verified date: March 2020
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: December 1, 2024
• Est. primary completion date: November 12, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol-Induced Disorders
• Liver Cirrhosis
• Liver Fibroses

Intervention

Other:
• Ethanol
1 milliliter per kilogram body weight adjusted for elevated body mass index

Locations

Country	Name	City	State
Denmark	Odense University Hospital	Odense	Fyn

Sponsors (1)

Lead Sponsor	Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in concentrations of bacterial products in the liver vein		Within 24 hours
Secondary	changes in concentrations of bacterial products in the peripheral vein system		Within 24 hours
Secondary	changes in the gut microbiome		Within 24 hours
Secondary	changes in the liver metabolome, transcriptome and proteome		Within 24 hours
Secondary	changes in serum-ethanol, plasma-glucose and liver biomarkers in the liver vein compared to the peripheral vein system		Within 24 hours