Patients With Fatty Liver DiseaseFLMNCT03748511
Identification of Microbial Properties Predicting a Worsening Course of Fatty Liver Disease
An observational study of Patients With Fatty Liver Disease, run by HaEmek Medical Center, Israel at 1 site in Israel.
Trial summary
This study investigates the relation between the gastrointestinal tract bacteria and the progression of fatty liver disease . Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Patients With Fatty Liver Disease
- What is being tested?
- fibroscan and stool sample
- How many people
- 62 participants
- Where
- 1 siteIsrael
- Study dates
- 5 Mar 2019to 8 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Adult, Older adult
Study population: 60 patients with fatty liver disease
Who may be able to join
- patients with non alcoholic fatty liver disese.
- patients who give approval to participate in the study
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Patients With Fatty Liver Disease
- Being tested
- fibroscan and stool sample
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fibroscan and stool sampleOther
Also called fibroscan is also called shear wave
patients undergo ultrasaound (fibroscan) in order to stage the liver disease.
| Study group | Role | What they receive |
|---|---|---|
| fatty liver disease 0-1F | 20 patients with uncomplicated liver disease, with fibrosis stage 0-1F. Receives: Other: fibroscan and stool sample | |
| fatty liver disease 2F | 20 patients with liver disease, fibrosis stage 2F. Receives: Other: fibroscan and stool sample | |
| fatty liver disease 3-4F | 20 patients with advanced liver disease, fibrosis stage 3-4F. Receives: Other: fibroscan and stool sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2018
- Study start5 Mar 2019
- Primary completion8 Sep 2022
- Study completion8 Sep 2022
Why it stopped: COVID-19 interrupted the recruitment process and imposed difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Fatty Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rawi Hazzan, HaEmek Medical Center, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03748511
- Sponsor's protocol ID
- 179-17-EMC
- Acronym
- FLM
- Status last verified
- Mar 2023
- First submitted
- 17 Sep 2018
- Last updated
- 6 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Microbial Properties Predicting a Worsening Course of Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT03748511
- Acronym / sponsor ID
- FLM / 179-17-EMC
- Conditions
- Patients With Fatty Liver Disease
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: COVID-19 interrupted the recruitment process and imposed difficulties
- Enrolment
- 62 participants (actual)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- 5 Mar 2019 (actual)
- Primary completion
- 8 Sep 2022 (actual)
- Study completion
- 8 Sep 2022 (actual)
- First posted
- 21 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| fatty liver disease 0-1F | – | Other: fibroscan and stool sample20 patients with uncomplicated liver disease, with fibrosis stage 0-1F. |
| fatty liver disease 2F | – | Other: fibroscan and stool sample20 patients with liver disease, fibrosis stage 2F. |
| fatty liver disease 3-4F | – | Other: fibroscan and stool sample20 patients with advanced liver disease, fibrosis stage 3-4F. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 60 patients with fatty liver disease
Key inclusion criteria (2 listed)
- patients with non alcoholic fatty liver disese.
- patients who give approval to participate in the study
Key exclusion criteria (13 listed)
- liver failure
- acute or chronic kidney failure
- heart failure ( NYHA 3-4)
- active cancer
- fatty liver due to non alcoholic etiology.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fibroscan and stool sampleAlso: fibroscan is also called shear wavepatients undergo ultrasaound (fibroscan) in order to stage the liver disease. | Other | fatty liver disease 0-1F, fatty liver disease 2F, fatty liver disease 3-4F |
Primary outcome
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.
1 secondary outcome
Gastrointestinal Microbiome test
Time frame: up to 1 month
Results and safety
The study was stopped early (reason given: COVID-19 interrupted the recruitment process and imposed difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2023.
- Individual participant dataSharing planned: No
Related trials for Patients With Fatty Liver Disease
Active, not recruitingObservational study
Screening for Hyperuricemia in Patients With Metabolic Associated Fatty Liver Disease (MAFLD)
Hyperuricemia and MAFLD
Not yet recruiting
Personalized Dietary Feedback to Reduce Hepatic Steatosis in Patients With MASLD
MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease), MetALD
Active, not recruitingPhase 3
A Phase 3 Study Evaluating Efficacy and Safety of Lanifibranor Followed by an Active Treatment Extension in Adult Patients With (NASH) and Fibrosis Stages F2 and F3 ( NATiV3 )
NASH - Nonalcoholic Steatohepatitis
Active, not recruitingObservational study
Assessment of the Prevalence of Steatotic Liver Disease Associated With Metabolic Dysfunction in Patients With Heterozygous Familial Hypercholesterolemia
Heterozygous Familial Hypercholesterolemia
Active, not recruitingPhase 2
Trial of CS060380 Tablets for Non-alcoholic Steatohepatitis (NASH)
NASH
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients With Fatty Liver Disease, run by HaEmek Medical Center, Israel at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: COVID-19 interrupted the recruitment process and imposed difficulties). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transient Elastography Test (time frame: up to 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2023.