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TerminatedNCT03748511FLMUpdated Mar 6, 2023

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

An observational study in Patients With Fatty Liver Disease, sponsored by HaEmek Medical Center, Israel. Terminated at 1 site in Israel. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-03-06.

Sponsored by HaEmek Medical Center, Israel · Observational

Why this study was terminated
COVID-19 interrupted the recruitment process and imposed difficulties
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
62
Ages
18 Years to 75 Years
Sex
All
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Study summary

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

Read the 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.

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Conditions studied

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In context

Liver Diseases

2,081 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.

This study's enrollment of 62 is below the median of 167 across 681 observational studies indexed under Liver Diseases.

Browse Liver Diseases studies →

Lead sponsor

HaEmek Medical Center, Israel is the lead sponsor of 228 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

60 patients with fatty liver disease

Inclusion criteria

  • patients with non alcoholic fatty liver disese.
  • patients who give approval to participate in the study

Exclusion criteria

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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
62 participants (actual)
Patient registry
No

Groups and cohorts

  • fatty liver disease 0-1F

    20 patients with uncomplicated liver disease, with fibrosis stage 0-1F.

    Other: fibroscan and stool sample

  • fatty liver disease 2F

    20 patients with liver disease, fibrosis stage 2F.

    Other: fibroscan and stool sample

  • fatty liver disease 3-4F

    20 patients with advanced liver disease, fibrosis stage 3-4F.

    Other: fibroscan and stool sample

Interventions

  • Otherfibroscan and stool sample

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

    Also known as: fibroscan is also called shear wave

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: up to 2 hours

Secondary outcomes

  1. 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.

    Time frame: up to 1 month

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Study locations

1 site
  • Liver Init
    Afula, 1834111, Israel
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 6, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03748511
Lead sponsor
HaEmek Medical Center, Israel
Responsible party
Rawi Hazzan (Head of Liver Unit, HaEmek Medical Center, Israel) — Principal investigator
First posted
Nov 21, 2018
Start date
Mar 5, 2019
Primary completion
Sep 8, 2022
Completion
Sep 8, 2022
Last update
Mar 6, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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