Identification of Microbial Properties Predicting a Worsening Course of Fatty Liver Disease (FLM)
March 2, 2023 updated by: Rawi Hazzan, HaEmek Medical Center, Israel
This study investigates the relation between the gastrointestinal tract bacteria and the progression of fatty liver disease .
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Afula, Israel, 1834111
- Liver Init
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
fatty liver disease 0-1F
20 patients with uncomplicated liver disease, with fibrosis stage 0-1F.
|
patients undergo ultrasaound (fibroscan) in order to stage the liver disease.
Other Names:
|
|
fatty liver disease 2F
20 patients with liver disease, fibrosis stage 2F.
|
patients undergo ultrasaound (fibroscan) in order to stage the liver disease.
Other Names:
|
|
fatty liver disease 3-4F
20 patients with advanced liver disease, fibrosis stage 3-4F.
|
patients undergo ultrasaound (fibroscan) in order to stage the liver disease.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Transient Elastography Test
Time Frame: 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. |
up to 2 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Gastrointestinal Microbiome test
Time Frame: 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.
|
up to 1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.