- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02650115
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) (MICRONACH)
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%.
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 Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Angers, France, 49933
- Chu Angers
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Nantes, France, 44035
- CHU Nantes
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Rennes, France, 35000
- CHU Rennes
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Toulouse, France, 31059
- CHU Toulouse
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with a significant hepatic fibrosis confirmed by a liver biopsy
Time Frame: at baseline (Day of liver biopsy)
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Number of participants with a significant hepatic fibrosis confirmed by a liver biopsy
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at baseline (Day of liver biopsy)
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Collaborators and Investigators
Investigators
- Study Director: Matthieu SCHNEE, PH, CHD Vendée de la Roche sur Yon
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHD020-15
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.
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