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

Patients With Fatty Liver Disease Clinical Trial

— FLM  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03748511
• Other study ID #: 179-17-EMC
• Status: Terminated
• Start date: March 5, 2019
• Est. completion date: September 8, 2022

Study information

• Verified date: March 2023
• Source: HaEmek Medical Center, Israel
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 62
• Est. completion date: September 8, 2022
• Est. primary completion date: September 8, 2022
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-alcoholic Fatty Liver Disease
• Patients With Fatty Liver Disease

Intervention

Other:
• fibroscan and stool sample
patients undergo ultrasaound (fibroscan) in order to stage the liver disease.

Locations

Country	Name	City	State
Israel	Liver Init	Afula

Sponsors (1)

Lead Sponsor	Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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