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

March 6, 2020 updated by: Mads Israelsen, Odense University Hospital
To investigate the effects of acute alcohol challenge on the gut and liver axis.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Fyn
      • Odense, Fyn, Denmark, 5000
        • Odense University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Alcoholic liver fibrosis
Other: Ethanol
1 milliliter per kilogram body weight adjusted for elevated body mass index
Active Comparator: Non-alcoholic steatohepatitis
Other: Ethanol
1 milliliter per kilogram body weight adjusted for elevated body mass index
Active Comparator: Healthy control
Other: Ethanol
1 milliliter per kilogram body weight adjusted for elevated body mass index

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
changes in concentrations of bacterial products in the liver vein
Time Frame: Within 24 hours
Within 24 hours

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Odense University Hospital

Investigators

  • Principal Investigator: Aleksander Krag, MD, PhD, Professor, department of gastroenterology and hepatology, Odense University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 9, 2016

Primary Completion (Actual)

November 12, 2018

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

January 11, 2017

First Submitted That Met QC Criteria

January 11, 2017

First Posted (Estimate)

January 12, 2017

Study Record Updates

Last Update Posted (Actual)

March 10, 2020

Last Update Submitted That Met QC Criteria

March 6, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S-20160083

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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