Evaluation of the Involvement of the Intestinal Microbiota and Choline Deficiency in the Severity… (NCT02650115) | Clinical Trial Compass
CompletedNot Applicable
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)
France300 participantsStarted 2017-04-06
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 protecti…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants with a significant hepatic fibrosis confirmed by a liver biopsy