Identification of Microbial Properties Predicting a Worsening Course of Fatty Liver Disease
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Patients With Fatty Liver Disease
- Sponsor
- HaEmek Medical Center, Israel
- Enrollment
- 62
- Locations
- 1
- Primary Endpoint
- Transient Elastography Test
- Status
- Terminated
- Last Updated
- 3 years ago
Overview
Brief Summary
This study investigates the relation between the gastrointestinal tract bacteria and the progression of fatty liver disease .
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.
Investigators
Rawi Hazzan
Head of Liver Unit
HaEmek Medical Center, Israel
Eligibility 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.
Outcomes
Primary Outcomes
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 Outcomes
- Gastrointestinal Microbiome test(up to 1 month)