Liver Disease (Alcoholic or Not)MICRONACHNCT02650115
Evaluation of the Involvement of the Intestinal Microbiota and Choline Deficiency in the Severity of Chronic Liver Disease Explored by Analyzing Collection of Biological Samples (MICRONACH)
An observational study of Liver Disease (Alcoholic or Not), run by Centre Hospitalier Departemental Vendee at 4 sites in France.
Trial summary
Chronic liver diseases are common and the two main causes in France are NAFLD (No Alcoholic Fatty Liver Disease Nonalcoholic) and ALD (alcoholic liver disease). Because of the importance of the current global obesity, NAFLD has become very common and it is estimated that its prevalence in the general population… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Liver Disease (Alcoholic or Not)
- How many people
- 300 participants
- Where
- 4 sitesFrance
- Study dates
- 6 Apr 2017to 12 Dec 2020
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants in this study will be selected by the investigators of each center among patients for whom a liver biopsy is provided in the clinical management in their center.
Who may be able to join
- NAFLD (No alcoholic liver disease) and / or ALD (alcoholic liver disease)
- Liver biopsy scheduled
- NAFLD is defined by the presence of hepatic steatosis (ultrasound or retrospectively confirmed histologically) without concomitant treatment responsible for steatosis (corticosteroids, amiodarone, methotrexate, tamoxifen) without risk drinking of alcoholic beverages (> 210 g / week in men or> 140 g / week in women), and no other cause of chronic liver disease.
- ALD will be defined by the presence of chronic liver disease in a patient with a risk of alcohol consumption (> 210 g / week in men or> 140 g / week in women).
- Obtaining the opposition not to participate in the study
- Obtaining the signature of consent on the collection of biological samples of each participating centers
- Affiliation to the social security system
Who cannot join
- Cause concomitant chronic liver disease other than NAFLD or ALD
- concomitant treatment responsible for steatosis (steroids, amiodarone, methotrexate, tamoxifen)
- Previous history of bariatric surgery
- Antibiotic treatment in the two months prior to inclusion
- Refusal to participate and / or Non-obtaining consent for collection of biological samples
- Pregnant woman, parturient or nursing mothers. The absence of pregnancy will be provided on condition of effective contraception or after control negativity biological markers of pregnancy (b-HCG)
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- Minor Person
- Major Persons subject to enhanced protection, deprived of their liberty by judicial or administrative decision, without consent hospitalized or admitted to a health or social establishment for purposes other than research
- Person who is not affiliated to a social security scheme or of such a regime
Trial locations and contacts
4 sites in 1 country.
France4 sites
CHU Angers
Angers, 49933
CHU Nantes
Nantes, 44035
CHU Rennes
Rennes, 35000
CHU Toulouse
Toulouse, 31059
About this study
Official title: Evaluation of the Involvement of the Intestinal Microbiota and Choline Deficiency in the Severity of Chronic Liver Disease Explored by Analyzing Collection of Biological Samples
Chronic liver diseases are common and the two main causes in France are NAFLD (No Alcoholic Fatty Liver Disease Nonalcoholic) and ALD (alcoholic liver disease).
Because of the importance of the current global obesity, NAFLD has become very common and it is estimated that its prevalence in the general population reaches 20-30%.
Read more
NAFLD (No Alcoholic Fatty Liver Disease Nonalcoholic) and ALD (alcoholic liver disease) includes a broad spectrum of liver damage, ranging from simple steatosis isolated (infiltration of fat in the liver), in hepatic inflammation, fibrosis (abnormally high accumulation of extracellular components in the functional liver tissue) and finally cirrhosis and its complications.
Choline deficiency (essential nutrient generally classified as Class B vitamins) has been associated with liver damage each characterizing NAFLD and ALD. The amount of choline in the body depends in particular on food intake and degradation of choline by the intestinal microbiota.
NAFLD and ALD are complex pathologies resulting from the interaction of environmental / nutritional factors and a genetic background. It therefore appears now necessary to study the influence of the relationship between genetic predisposition, environmental factors, and gut microbiota metabolism of choline on the severity of liver injury observed in NAFLD and ALD.
If the interaction of these three elements (the host genetics - environmental factors - and intestinal microbiota metabolic choline) has an influence on the severity of the lesions of NAFLD and ALD direct application may be of bring a food supplement choline in patients at risk (mutation of the PEMT gene (phosphatidylethanolamine N-methyltransferase), postmenopausal women, microbiota profile for increased degradation of dietary choline) to restore the amount of choline in the body and thus to avoid a worsening of the ALD or NAFLD and progression to cirrhosis.
- Conditions
- Liver Disease (Alcoholic or Not)
- Medical subject headings
- Liver Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with a significant hepatic fibrosis confirmed by a liver biopsy
Number of participants with a significant hepatic fibrosis confirmed by a liver biopsy
Measured: at baseline (Day of liver biopsy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2016 (estimated)
- Study start6 Apr 2017
- Primary completion12 Dec 2020
- Study completion12 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Disease (Alcoholic or Not)Studies 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
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Departemental Vendee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthieu SCHNEE, PH, Study director, CHD Vendée de la Roche sur Yon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02650115
- Sponsor's protocol ID
- CHD020-15
- Acronym
- MICRONACH
- Status last verified
- Jul 2021
- First submitted
- 6 Jan 2016
- Last updated
- 28 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Involvement of the Intestinal Microbiota and Choline Deficiency in the Severity of Chronic Liver Disease Explored by Analyzing Collection of Biological Samples
- ClinicalTrials.gov ID
- NCT02650115
- Acronym / sponsor ID
- MICRONACH / CHD020-15
- Conditions
- Liver Disease (Alcoholic or Not)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Centre Hospitalier Departemental VendeeUniversity, hospital or other
- Study start
- 6 Apr 2017 (actual)
- Primary completion
- 12 Dec 2020 (actual)
- Study completion
- 12 Dec 2020 (actual)
- First posted
- 8 Jan 2016 (estimated)
- 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.
Chronic liver diseases are common and the two main causes in France are NAFLD (No Alcoholic Fatty Liver Disease Nonalcoholic) and ALD (alcoholic liver disease).
Because of the importance of the current global obesity, NAFLD has become very common and it is estimated that its prevalence in the general population reaches 20-30%.
NAFLD (No Alcoholic Fatty Liver Disease Nonalcoholic) and ALD (alcoholic liver disease) includes a broad spectrum of liver damage, ranging from simple steatosis isolated (infiltration of fat in the liver), in hepatic inflammation, fibrosis (abnormally high accumulation of extracellular components in the functional liver tissue) and finally cirrhosis and its complications.
Choline deficiency (essential nutrient generally classified as Class B vitamins) has been associated with liver damage each characterizing NAFLD and ALD. The amount of choline in the body depends in particular on food intake and degradation of choline by the intestinal microbiota.
NAFLD and ALD are complex pathologies resulting from the interaction of environmental / nutritional factors and a genetic background. It therefore appears now necessary to study the influence of the relationship between genetic predisposition, environmental factors, and gut microbiota metabolism of choline on the severity of liver injury observed in NAFLD and ALD.
If the interaction of these three elements (the host genetics - environmental factors - and intestinal microbiota metabolic choline) has an influence on the severity of the lesions of NAFLD and ALD direct application may be of bring a food supplement choline in patients at risk (mutation of the PEMT gene (phosphatidylethanolamine N-methyltransferase), postmenopausal women, microbiota profile for increased degradation of dietary choline) to restore the amount of choline in the body and thus to avoid a worsening of the ALD or NAFLD and progression to cirrhosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants in this study will be selected by the investigators of each center among patients for whom a liver biopsy is provided in the clinical management in their center.
Key inclusion criteria (7 listed)
- NAFLD (No alcoholic liver disease) and / or ALD (alcoholic liver disease)
- Liver biopsy scheduled
- NAFLD is defined by the presence of hepatic steatosis (ultrasound or retrospectively confirmed histologically) without concomitant treatment responsible for steatosis (corticosteroids, amiodarone, methotrexate, tamoxifen) without risk drinking of alcoholic beverages (> 210 g / week in men or> 140 g / week in women), and no other cause of chronic liver disease.
- ALD will be defined by the presence of chronic liver disease in a patient with a risk of alcohol consumption (> 210 g / week in men or> 140 g / week in women).
- Obtaining the opposition not to participate in the study
Key exclusion criteria (9 listed)
- Cause concomitant chronic liver disease other than NAFLD or ALD
- concomitant treatment responsible for steatosis (steroids, amiodarone, methotrexate, tamoxifen)
- Previous history of bariatric surgery
- Antibiotic treatment in the two months prior to inclusion
- Refusal to participate and / or Non-obtaining consent for collection of biological samples
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of participants with a significant hepatic fibrosis confirmed by a liver biopsy
Time frame: at baseline (Day of liver biopsy)
Number of participants with a significant hepatic fibrosis confirmed by a liver biopsy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2021.
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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.
Matthieu SCHNEE, PH study director
CHD Vendée de la Roche sur Yon
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Disease (Alcoholic or Not), run by Centre Hospitalier Departemental Vendee at 4 sites in France.
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 7 inclusion and 9 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: finished, as of the sponsor's last update on 28 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of participants with a significant hepatic fibrosis confirmed by a liver biopsy (time frame: at baseline (Day of liver biopsy)). 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 28 Jul 2021.