French National MICMAF Cohort

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · May 30, 2023

Keywords

ClinConnect Summary

The French National MICMAF Cohort study is a clinical trial focused on understanding how the gut microbiome—made up of various microorganisms in our digestive system—affects alcoholic liver disease (ALD). This trial is particularly important because excessive alcohol consumption can lead to serious liver problems, including cirrhosis and liver cancer. Researchers want to find out how changes in the gut microbiome may predict the development of severe conditions like acute alcoholic hepatitis and cirrhosis. They will collect samples from participants over several years to track these changes and see how they relate to alcohol use and liver health.

To join this study, participants need to be between 18 and 75 years old and must have been drinking more than a certain amount of alcohol daily for the past year. They should also be receiving help for alcohol-related liver issues. The trial aims to enroll about 1,000 people across seven centers in France, and it will take place over a long period, with follow-ups lasting from five to twenty years. Participants will provide stool, saliva, and blood samples, which will help researchers learn more about the relationship between alcohol, the gut microbiome, and liver disease. This study could lead to better understanding and new treatments for those struggling with alcohol addiction and liver health.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age between 18 and 75 years
• • Average alcohol consumption of more than 20 g per day in women and 30 g per day in men during the previous year;
• • Patients seen in consultation or hospitalized for assessment of alcoholic liver disease and management of alcohol addiction;
• • Having given their consent to participate in this study;
• • Affiliated to a social security system (beneficiary or beneficiary's right).
• Exclusion Criteria:
• • Antibiotic, probiotic or prebiotic treatment within the previous 3 months ;
• • Digestive hemorrhage, acute pancreatitis, acute or chronic diarrhea (except diarrhea related to excessive alcohol consumption) or chronic inflammatory bowel disease;
• • Another cause of liver damage;
• • A serious associated pathology (respiratory failure, heart failure, severe psychiatric disorders, active cancer).
• • Patient under guardianship or curatorship