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Identification of Microbial Properties Predicting a Worsening Course of Fatty Liver Disease (FLM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03748511
Recruitment Status : Active, not recruiting
First Posted : November 21, 2018
Last Update Posted : February 21, 2020
Sponsor:
Information provided by (Responsible Party):
Rawi Hazzan, HaEmek Medical Center, Israel

Brief Summary:
This study investigates the relation between the gastrointestinal tract bacteria and the progression of fatty liver disease .

Condition or disease Intervention/treatment
Patients With Fatty Liver Disease Other: fibroscan and stool sample

Detailed Description:
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.

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Study Type : Observational
Actual Enrollment : 62 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Identification of Microbial Properties Predicting a Worsening Course of Fatty Liver Disease
Actual Study Start Date : March 5, 2019
Estimated Primary Completion Date : April 1, 2020
Estimated Study Completion Date : August 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Diseases

Group/Cohort Intervention/treatment
fatty liver disease 0-1F
20 patients with uncomplicated liver disease, with fibrosis stage 0-1F.
Other: fibroscan and stool sample
patients undergo ultrasaound (fibroscan) in order to stage the liver disease.
Other Name: fibroscan is also called shear wave

fatty liver disease 2F
20 patients with liver disease, fibrosis stage 2F.
Other: fibroscan and stool sample
patients undergo ultrasaound (fibroscan) in order to stage the liver disease.
Other Name: fibroscan is also called shear wave

fatty liver disease 3-4F
20 patients with advanced liver disease, fibrosis stage 3-4F.
Other: fibroscan and stool sample
patients undergo ultrasaound (fibroscan) in order to stage the liver disease.
Other Name: fibroscan is also called shear wave




Primary Outcome Measures :
  1. Transient Elastography Test [ Time Frame: up to 2 hours ]

    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.



Secondary Outcome Measures :
  1. Gastrointestinal Microbiome test [ Time Frame: up to 1 month ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
60 patients with fatty liver disease
Criteria

Inclusion Criteria:

  • patients with non alcoholic fatty liver disese.
  • patients who give approval to participate in the study

Exclusion Criteria:

  • liver failure
  • acute or chronic kidney failure
  • heart failure ( NYHA 3-4)
  • active cancer
  • fatty liver due to non alcoholic etiology.
  • patients who consume drugs from the estrogen/methotrexate family, or chloroquine.
  • history of hypothyrodism or cushing.
  • patients who used TPA in the last 6 months .
  • pathients with chronic liver disease like A1AT, hemochromatosis, wilson, toxic damage and autoimmunity .
  • special population like - children, pregnant women and patients who lack the ability to make judgment.
  • infectious liver disease - viral hepatitis or HIV.
  • inflammatory bowel disease.
  • patients who underwent surgery of the gastrointestinal trant.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03748511


Locations
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Israel
Liver Init
Afula, Israel, 1834111
Sponsors and Collaborators
HaEmek Medical Center, Israel
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Responsible Party: Rawi Hazzan, Head of Liver Unit, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT03748511    
Other Study ID Numbers: 179-17-EMC
First Posted: November 21, 2018    Key Record Dates
Last Update Posted: February 21, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Digestive System Diseases