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Trial record 37 of 164 for:    PEMT

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
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Departemental Vendee

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.


Condition or disease
Liver Disease (Alcoholic or Not)

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Diseases




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Lucie AUZANNEAU, ARC 0251446380 ext +33 lucie.auzanneau@chd-vendee.fr

Locations
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France
CHU Angers Recruiting
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         
Sponsors and Collaborators
Centre Hospitalier Departemental Vendee
Investigators
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Study Director: Matthieu SCHNEE, PH CHD Vendée de la Roche sur Yon

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Responsible Party: Centre Hospitalier Departemental Vendee
ClinicalTrials.gov Identifier: NCT02650115     History of Changes
Other Study ID Numbers: CHD020-15
First Posted: January 8, 2016    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019

Additional relevant MeSH terms:
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Liver Diseases
Choline Deficiency
Digestive System Diseases
Vitamin B Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Choline
Lipotropic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Lipid Regulating Agents
Nootropic Agents