<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03018990</url>
  </required_header>
  <id_info>
    <org_study_id>S-20160083</org_study_id>
    <nct_id>NCT03018990</nct_id>
  </id_info>
  <brief_title>Alcohol Challenge On Liver and Gut Measured by Liver Vein Catheterization. A Pathophysiological Intervention Trial</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Odense University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Odense University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To investigate the effects of acute alcohol challenge on the gut and liver axis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To study the role of acute alcohol challenge on the intestine permeability and inflow of&#xD;
      bacterial products to the liver in participants with alcoholic liver disease, non-alcoholic&#xD;
      steatohepatitis and healthy controls.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">November 9, 2016</start_date>
  <completion_date type="Anticipated">December 1, 2024</completion_date>
  <primary_completion_date type="Actual">November 12, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>changes in concentrations of bacterial products in the liver vein</measure>
    <time_frame>Within 24 hours</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>changes in concentrations of bacterial products in the peripheral vein system</measure>
    <time_frame>Within 24 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>changes in the gut microbiome</measure>
    <time_frame>Within 24 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>changes in the liver metabolome, transcriptome and proteome</measure>
    <time_frame>Within 24 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>changes in serum-ethanol, plasma-glucose and liver biomarkers in the liver vein compared to the peripheral vein system</measure>
    <time_frame>Within 24 hours</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Liver Fibroses</condition>
  <condition>Alcohol-Induced Disorders</condition>
  <arm_group>
    <arm_group_label>Alcoholic liver fibrosis</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-alcoholic steatohepatitis</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Ethanol</intervention_name>
    <description>1 milliliter per kilogram body weight adjusted for elevated body mass index</description>
    <arm_group_label>Alcoholic liver fibrosis</arm_group_label>
    <arm_group_label>Healthy control</arm_group_label>
    <arm_group_label>Non-alcoholic steatohepatitis</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Alcoholic liver fibrosis, non-alcoholic steatohepatitis or liver-healthy individuals&#xD;
&#xD;
        And all of following:&#xD;
&#xD;
          -  Bodymass &gt; 50 kg&#xD;
&#xD;
          -  Able to be fasting and abstinent on the day of intervention&#xD;
&#xD;
          -  international ratio &lt;1.5 and platelets &gt;100 x 10^9, 7 days before the intervention day&#xD;
&#xD;
          -  Informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Antibiotics during the last 4 weeks&#xD;
&#xD;
          -  Total alcohol abstinence&#xD;
&#xD;
          -  Desire of total alcohol abstinence&#xD;
&#xD;
          -  Other causes of liver disease suspected (viral, autoimmune, haemochromatosis, Wilsons&#xD;
             diseases, alfa 1 antitrypsin deficiency or drug induced)&#xD;
&#xD;
          -  Cirrhosis&#xD;
&#xD;
          -  Insulin dependent diabetes mellitus&#xD;
&#xD;
          -  Incapable to follow the protocol instructions&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Primary or secondary liver cancer&#xD;
&#xD;
          -  Severe comorbidity&#xD;
&#xD;
          -  Allergic to the contrast media iohexol&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Aleksander Krag, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Professor, department of gastroenterology and hepatology, Odense University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Odense University Hospital</name>
      <address>
        <city>Odense</city>
        <state>Fyn</state>
        <zip>5000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>January 11, 2017</study_first_submitted>
  <study_first_submitted_qc>January 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 12, 2017</study_first_posted>
  <last_update_submitted>March 6, 2020</last_update_submitted>
  <last_update_submitted_qc>March 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Odense University Hospital</investigator_affiliation>
    <investigator_full_name>Mads Israelsen</investigator_full_name>
    <investigator_title>MD,clinical research assistant, PhD-student</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Cirrhosis</mesh_term>
    <mesh_term>Alcohol-Induced Disorders</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ethanol</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03018990
org study id: S-20160083
nct id: NCT03018990
lead sponsor: 
has dmc: No
To investigate the effects of acute alcohol challenge on the gut and liver axis.
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.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: changes in concentrations of bacterial products in the liver vein
time frame: Within 24 hours
measure: changes in concentrations of bacterial products in the peripheral vein system
time frame: Within 24 hours
measure: changes in the gut microbiome
time frame: Within 24 hours
measure: changes in the liver metabolome, transcriptome and proteome
time frame: Within 24 hours
measure: changes in serum-ethanol, plasma-glucose and liver biomarkers in the liver vein compared to the peripheral vein system
time frame: Within 24 hours
arm group label: Alcoholic liver fibrosis
arm group type: Active Comparator
arm group label: Non-alcoholic steatohepatitis
arm group type: Active Comparator
arm group label: Healthy control
arm group type: Active Comparator
intervention type: Other
intervention name: Ethanol
description: 1 milliliter per kilogram body weight adjusted for elevated body mass index
arm group label: Alcoholic liver fibrosis
arm group label: Healthy control
arm group label: Non-alcoholic steatohepatitis
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Aleksander Krag, MD, PhD
role: Principal Investigator
affiliation: Professor, department of gastroenterology and hepatology, Odense University Hospital
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Odense University Hospital
investigator full name: Mads Israelsen
investigator title: MD,clinical research assistant, PhD-student
mesh term: Liver Cirrhosis
mesh term: Alcohol-Induced Disorders
mesh term: Ethanol