<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/NCT03748511</url>
  </required_header>
  <id_info>
    <org_study_id>179-17-EMC</org_study_id>
    <nct_id>NCT03748511</nct_id>
  </id_info>
  <brief_title>Identification of Microbial Properties Predicting a Worsening Course of Fatty Liver Disease</brief_title>
  <acronym>FLM</acronym>
  <official_title>Identification of Microbial Properties Predicting a Worsening Course of Fatty Liver Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>HaEmek Medical Center, Israel</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>HaEmek Medical Center, Israel</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study investigates the relation between the gastrointestinal tract bacteria and the&#xD;
      progression of fatty liver disease .&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the gastrointestinal (GI) tract live wide spectrum of bacteria, in this study we are&#xD;
      trying to find if there is a relation between the GI tract bacteria and the development of&#xD;
      non alcoholic fatty liver disease, the results of the this study may help us identify the&#xD;
      stage of liver disease in noninvasive means and enables us to adopt methods to reduce&#xD;
      morbodity.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    COVID-19 interrupted the recruitment process and imposed difficulties&#xD;
  </why_stopped>
  <start_date type="Actual">March 5, 2019</start_date>
  <completion_date type="Actual">September 8, 2022</completion_date>
  <primary_completion_date type="Actual">September 8, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Transient Elastography Test</measure>
    <time_frame>up to 2 hours</time_frame>
    <description>Ultrasound Elastography is a non-invasive test which uses the technology of Shear Wave Elastography (SWE) obtained from the right liver lobe for staging liver fibrosis according to Metavir Fibrosis Score .&#xD;
Metavir Fibrosis Score is a system used to assess the extent of inflammation and fibrosis by histopathological evaluation in a liver biopsy.&#xD;
Liver fibrosis assessed by Shear Wave Elastography is well correlated to biopsy using Metavir Score.&#xD;
The outcome of the test will be correlated to Metavir Score system according to the chart below:&#xD;
SWE (kiloPascal) , METAVIR score, Fibrosis Level. Below 5 , F0 , No fibrosis. 5.0-7.1 , F1 , Mild Fibrosis. 7.1-8.7 , F2 , Significant Fibrosis. 8.7-10.4 , F3 , Sever Fibrosis . 10.4-19 , F4 , Cirrhosis.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Gastrointestinal Microbiome test</measure>
    <time_frame>up to 1 month</time_frame>
    <description>The test will be made by a new meta-genomic sequencing technology (Next Generation Sequencing) which gives us unbiased information about all the gastrointestinal bacterial characteristics.</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">62</enrollment>
  <condition>Patients With Fatty Liver Disease</condition>
  <arm_group>
    <arm_group_label>fatty liver disease 0-1F</arm_group_label>
    <description>20 patients with uncomplicated liver disease, with fibrosis stage 0-1F.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>fatty liver disease 2F</arm_group_label>
    <description>20 patients with liver disease, fibrosis stage 2F.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>fatty liver disease 3-4F</arm_group_label>
    <description>20 patients with advanced liver disease, fibrosis stage 3-4F.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>fibroscan and stool sample</intervention_name>
    <description>patients undergo ultrasaound (fibroscan) in order to stage the liver disease.</description>
    <arm_group_label>fatty liver disease 0-1F</arm_group_label>
    <arm_group_label>fatty liver disease 2F</arm_group_label>
    <arm_group_label>fatty liver disease 3-4F</arm_group_label>
    <other_name>fibroscan is also called shear wave</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        60 patients with fatty liver disease&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with non alcoholic fatty liver disese.&#xD;
&#xD;
          -  patients who give approval to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  liver failure&#xD;
&#xD;
          -  acute or chronic kidney failure&#xD;
&#xD;
          -  heart failure ( NYHA 3-4)&#xD;
&#xD;
          -  active cancer&#xD;
&#xD;
          -  fatty liver due to non alcoholic etiology.&#xD;
&#xD;
          -  patients who consume drugs from the estrogen/methotrexate family, or chloroquine.&#xD;
&#xD;
          -  history of hypothyrodism or cushing.&#xD;
&#xD;
          -  patients who used TPA in the last 6 months .&#xD;
&#xD;
          -  pathients with chronic liver disease like A1AT, hemochromatosis, wilson, toxic damage&#xD;
             and autoimmunity .&#xD;
&#xD;
          -  special population like - children, pregnant women and patients who lack the ability&#xD;
             to make judgment.&#xD;
&#xD;
          -  infectious liver disease - viral hepatitis or HIV.&#xD;
&#xD;
          -  inflammatory bowel disease.&#xD;
&#xD;
          -  patients who underwent surgery of the gastrointestinal trant.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Liver Init</name>
      <address>
        <city>Afula</city>
        <zip>1834111</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>September 17, 2018</study_first_submitted>
  <study_first_submitted_qc>November 18, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 21, 2018</study_first_posted>
  <last_update_submitted>March 2, 2023</last_update_submitted>
  <last_update_submitted_qc>March 2, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>HaEmek Medical Center, Israel</investigator_affiliation>
    <investigator_full_name>Rawi Hazzan</investigator_full_name>
    <investigator_title>Head of Liver Unit</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Diseases</mesh_term>
    <mesh_term>Fatty Liver</mesh_term>
    <mesh_term>Non-alcoholic Fatty Liver Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03748511
org study id: 179-17-EMC
nct id: NCT03748511
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study investigates the relation between the gastrointestinal tract bacteria and the
      progression of fatty liver disease .
In the gastrointestinal (GI) tract live wide spectrum of bacteria, in this study we are
      trying to find if there is a relation between the GI tract bacteria and the development of
      non alcoholic fatty liver disease, the results of the this study may help us identify the
      stage of liver disease in noninvasive means and enables us to adopt methods to reduce
      morbodity.
observational model: Cohort
time perspective: Prospective
measure: Transient Elastography Test
time frame: up to 2 hours
description: Ultrasound Elastography is a non-invasive test which uses the technology of Shear Wave Elastography (SWE) obtained from the right liver lobe for staging liver fibrosis according to Metavir Fibrosis Score .
Metavir Fibrosis Score is a system used to assess the extent of inflammation and fibrosis by histopathological evaluation in a liver biopsy.
Liver fibrosis assessed by Shear Wave Elastography is well correlated to biopsy using Metavir Score.
The outcome of the test will be correlated to Metavir Score system according to the chart below:
SWE (kiloPascal) , METAVIR score, Fibrosis Level. Below 5 , F0 , No fibrosis. 5.0-7.1 , F1 , Mild Fibrosis. 7.1-8.7 , F2 , Significant Fibrosis. 8.7-10.4 , F3 , Sever Fibrosis . 10.4-19 , F4 , Cirrhosis.
measure: Gastrointestinal Microbiome test
time frame: up to 1 month
description: The test will be made by a new meta-genomic sequencing technology (Next Generation Sequencing) which gives us unbiased information about all the gastrointestinal bacterial characteristics.
arm group label: fatty liver disease 0-1F
description: 20 patients with uncomplicated liver disease, with fibrosis stage 0-1F.
arm group label: fatty liver disease 2F
description: 20 patients with liver disease, fibrosis stage 2F.
arm group label: fatty liver disease 3-4F
description: 20 patients with advanced liver disease, fibrosis stage 3-4F.
intervention type: Other
intervention name: fibroscan and stool sample
description: patients undergo ultrasaound (fibroscan) in order to stage the liver disease.
arm group label: fatty liver disease 0-1F
arm group label: fatty liver disease 2F
arm group label: fatty liver disease 3-4F
other name: fibroscan is also called shear wave
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
facility: 
country: Israel
responsible party type: Principal Investigator
investigator affiliation: HaEmek Medical Center, Israel
investigator full name: Rawi Hazzan
investigator title: Head of Liver Unit
mesh term: Liver Diseases
mesh term: Fatty Liver
mesh term: Non-alcoholic Fatty Liver Disease
sharing ipd: No