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

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

Study Overview

• Status: Terminated
• Conditions: Patients With Fatty Liver Disease
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 62

Contacts and Locations

Study Locations

• Israel
  • Afula, Israel, 1834111
    • Liver Init

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

60 patients with fatty liver disease

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

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 Names: 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 Names: 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 Names: fibroscan is also called shear wave

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: HaEmek Medical Center, Israel

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2019
• Primary Completion (Actual): September 8, 2022
• Study Completion (Actual): September 8, 2022

Study Registration Dates

• First Submitted: September 17, 2018
• First Submitted That Met QC Criteria: November 18, 2018
• First Posted (Actual): November 21, 2018

Study Record Updates

• Last Update Posted (Estimate): March 6, 2023
• Last Update Submitted That Met QC Criteria: March 2, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: 179-17-EMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No