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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03748511
Recruitment Status : Active, not recruiting
First Posted : November 21, 2018
Last Update Posted : February 21, 2020
Sponsor:
Information provided by (Responsible Party):
Rawi Hazzan, HaEmek Medical Center, Israel

Tracking Information
First Submitted Date September 17, 2018
First Posted Date November 21, 2018
Last Update Posted Date February 21, 2020
Actual Study Start Date March 5, 2019
Estimated Primary Completion Date April 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 18, 2018)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: November 18, 2018)
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Identification of Microbial Properties Predicting a Worsening Course of Fatty Liver Disease
Official Title Identification of Microbial Properties Predicting a Worsening Course of 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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population 60 patients with fatty liver disease
Condition Patients With Fatty Liver Disease
Intervention Other: fibroscan and stool sample
patients undergo ultrasaound (fibroscan) in order to stage the liver disease.
Other Name: fibroscan is also called shear wave
Study Groups/Cohorts
  • fatty liver disease 0-1F
    20 patients with uncomplicated liver disease, with fibrosis stage 0-1F.
    Intervention: Other: fibroscan and stool sample
  • fatty liver disease 2F
    20 patients with liver disease, fibrosis stage 2F.
    Intervention: Other: fibroscan and stool sample
  • fatty liver disease 3-4F
    20 patients with advanced liver disease, fibrosis stage 3-4F.
    Intervention: Other: fibroscan and stool sample
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: February 20, 2020)
62
Original Estimated Enrollment
 (submitted: November 18, 2018)
60
Estimated Study Completion Date August 1, 2020
Estimated Primary Completion Date April 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Israel
Removed Location Countries  
 
Administrative Information
NCT Number NCT03748511
Other Study ID Numbers 179-17-EMC
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Rawi Hazzan, HaEmek Medical Center, Israel
Study Sponsor HaEmek Medical Center, Israel
Collaborators Not Provided
Investigators Not Provided
PRS Account HaEmek Medical Center, Israel
Verification Date February 2020