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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03018990
Enrollment
40
Registered
2017-01-12
Start date
2016-11-09
Completion date
2024-12-01
Last updated
2020-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol-Induced Disorders, Liver Fibroses

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.

Interventions

OTHEREthanol

1 milliliter per kilogram body weight adjusted for elevated body mass index

Sponsors

Odense University Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
changes in concentrations of bacterial products in the liver veinWithin 24 hours

Secondary

MeasureTime frame
changes in concentrations of bacterial products in the peripheral vein systemWithin 24 hours
changes in the gut microbiomeWithin 24 hours
changes in the liver metabolome, transcriptome and proteomeWithin 24 hours
changes in serum-ethanol, plasma-glucose and liver biomarkers in the liver vein compared to the peripheral vein systemWithin 24 hours

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026