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)

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.

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Key information

Conditions

Liver Disease (Alcoholic or Not) Digestive System Diseases Liver Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Angers, Angers, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Departemental Vendee

Other

Registry information

Official study 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

Acronym: MICRONACH

Important dates

Study start: 2017
Primary completion: 2020
Study completion: 2020
First posted: Jan 8, 2016
Registry last updated: Jul 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed