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)
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|ClinicalTrials.gov Identifier: NCT02650115|
Recruitment Status : Recruiting
First Posted : January 8, 2016
Last Update Posted : April 16, 2019
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.
|Condition or disease|
|Liver Disease (Alcoholic or Not)|
|Study Type :||Observational|
|Estimated Enrollment :||300 participants|
|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|
|Actual Study Start Date :||April 6, 2017|
|Estimated Primary Completion Date :||April 2021|
|Estimated Study Completion Date :||April 2021|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02650115
|Contact: Lucie AUZANNEAU, ARC||0251446380 ext +firstname.lastname@example.org|
|Angers, France, 49933|
|Principal Investigator: Jérôme BOURSIER, PH|
|CHU Nantes||Not yet recruiting|
|Nantes, France, 44035|
|Principal Investigator: Isabelle ARCHAMBEAUD, PH|
|CHU Rennes||Not yet recruiting|
|Rennes, France, 35000|
|Principal Investigator: Edouard BARDOU-JACQUET, PH|
|CHU Toulouse||Not yet recruiting|
|Toulouse, France, 31059|
|Principal Investigator: Maeva GUILLAUME, PH|
|Study Director:||Matthieu SCHNEE, PH||CHD Vendée de la Roche sur Yon|