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)

NCT02650115 | Completed

• 1 other identifier: CHD020-15
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 4

Brief 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 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.

Conditions

Liver Disease (Alcoholic or Not)

Outcome Measures

Primary Outcomes (1)

• 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

  at baseline (Day of liver biopsy)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• Cause concomitant chronic liver disease other than NAFLD or ALD
• concomitant treatment responsible for steatosis (steroids, amiodarone, methotrexate, tamoxifen)
• Previous history of bariatric surgery
• 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

Sponsors & Collaborators

• Centre Hospitalier Departemental Vendee: lead

Study Sites (4)

CHU Angers

Angers, 49933, France

Location

CHU Nantes

Nantes, 44035, France

Location

CHU Rennes

Rennes, 35000, France

Location

CHU Toulouse

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Liver Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

• Matthieu SCHNEE, PH

  CHD Vendée de la Roche sur Yon

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2016
• First Posted: January 8, 2016
• Study Start: April 6, 2017
• Primary Completion: December 12, 2020
• Study Completion: December 12, 2020
• Last Updated: July 28, 2021

Record last verified: 2021-07

Locations

FR (4)