Identification of Microbial Properties Predicting a Worsening Course of Fatty Liver Disease

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

Detailed Description
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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.

Official Title
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Identification of Microbial Properties Predicting a Worsening Course of Fatty Liver Disease

Conditions
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Patients With Fatty Liver Disease

Intervention / Treatment
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* Other: fibroscan and stool sample


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| fatty liver disease 0-1F<br>20 patients with uncomplicated liver disease, with fibrosis stage 0-1F. | Other: fibroscan and stool sample<br>* patients undergo ultrasaound (fibroscan) in order to stage the liver disease.<br>* Other names: fibroscan is also called shear wave;|
| fatty liver disease 2F<br>20 patients with liver disease, fibrosis stage 2F. | Other: fibroscan and stool sample<br>* patients undergo ultrasaound (fibroscan) in order to stage the liver disease.<br>* Other names: fibroscan is also called shear wave;|
| fatty liver disease 3-4F<br>20 patients with advanced liver disease, fibrosis stage 3-4F. | Other: fibroscan and stool sample<br>* patients undergo ultrasaound (fibroscan) in order to stage the liver disease.<br>* Other names: fibroscan is also called shear wave;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transient Elastography Test | 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. | up to 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastrointestinal Microbiome test | 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. | up to 1 month |