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

NCT ID: NCT03748511

Last Updated: 2023-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

62 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-05

Study Completion Date

2022-09-08

Brief Summary

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

Detailed Description

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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.

Conditions

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Patients With Fatty Liver Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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fatty liver disease 0-1F

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

fibroscan and stool sample

Intervention Type OTHER

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

fatty liver disease 2F

20 patients with liver disease, fibrosis stage 2F.

fibroscan and stool sample

Intervention Type OTHER

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

fatty liver disease 3-4F

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

fibroscan and stool sample

Intervention Type OTHER

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

Interventions

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fibroscan and stool sample

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

Intervention Type OTHER

Other Intervention Names

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fibroscan is also called shear wave

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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HaEmek Medical Center, Israel

OTHER

Sponsor Role lead

Responsible Party

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Rawi Hazzan

Head of Liver Unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Liver Init

Afula, , Israel

Site Status

Countries

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Israel

Other Identifiers

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179-17-EMC

Identifier Type: -

Identifier Source: org_study_id

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