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

Terminated

• Conditions: Patients With Fatty Liver Disease
• Interventions: Other: fibroscan and stool sample

• Registration Number: NCT03748511
• Lead Sponsor: HaEmek Medical Center, Israel

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.

Study Timeline

• Study First Submitted: 2018-09-17
• Study First Submitted QC: 2018-11-18
• Study First Posted: 2018-11-21
• Study Start: 2019-03-05
• Primary Completion: 2022-09-08
• Study Completion: 2022-09-08
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-02
• Last Update Posted: 2023-03-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 62

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
fatty liver disease 2F	fibroscan and stool sample	20 patients with liver disease, fibrosis stage 2F.
fatty liver disease 0-1F	fibroscan and stool sample	20 patients with uncomplicated liver disease, with fibrosis stage 0-1F.
fatty liver disease 3-4F	fibroscan and stool sample	20 patients with advanced liver disease, fibrosis stage 3-4F.

Primary Outcome Measures

Name	Time	Method
Transient Elastography Test	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

Name	Time	Method
Gastrointestinal Microbiome test	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.

Trial Locations

Locations (1)

Liver Init; 🇮🇱 Afula, Israel