Skip to content

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

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

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03748511
Acronym
FLM
Enrollment
62
Registered
2018-11-21
Start date
2019-03-05
Completion date
2022-09-08
Last updated
2023-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients With Fatty Liver Disease

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.

Interventions

OTHERfibroscan and stool sample

patients undergo ultrasaound (fibroscan) in order to stage the liver disease.

Sponsors

HaEmek Medical Center, Israel
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years

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.

Design outcomes

Primary

MeasureTime frameDescription
Transient Elastography Testup to 2 hoursUltrasound 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

MeasureTime frameDescription
Gastrointestinal Microbiome testup to 1 monthThe 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.

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026