Study of the Evolution of the Intestinal Microbiome (Taxonomic and Functional Composition) During Alcoholic Liver Disease

Status: Recruiting
Location: See location...
Intervention Type: Genetic
Study Type: Observational
SUMMARY

Objective: To characterize temporal changes in the gut microbiome (bacterial, viral, and fungal) within sequential specimens (stool, saliva, serum) prior to the occurrence of acute alcoholic hepatitis episodes Secondary

Objectives: * Demonstrate that specific fecal, serum, or saliva microbiome profiles (bacterial, viral, and fungal) can predict the progression of alcoholic liver disease to severe alcoholic hepatitis, fibrosis, and cirrhosis. * Characterize changes in the composition of the gut microbiome (bacterial, viral and fungal) associated with the progression of alcoholic liver disease to severe alcoholic hepatitis and cirrhosis. * Characterize the changes in the microbiome during alcohol withdrawal. * Identify microbiome profiles associated with alcohol dependence and anxiety-depressive events related to alcohol addiction. * To identify bacterial species with a protective effect in alcoholic liver disease. * To identify beneficial bacterial species against alcohol dependence. * To study the microbiome-host interaction in alcoholic liver disease and alcohol addiction. * To identify microbiome profiles with prognostic value in severe alcoholic hepatitis and alcoholic cirrhosis. Number of centers: 7 Number of subjects expected 1000 Population concerned: The study will include a population of patients with excessive alcohol consumption seen in consultation or hospitalized for alcohol addiction problems and/or exploration of alcohol-related liver damage Inclusion period: January 2020 - January 2030 Patient observation period: 5 to 20 years Study duration: 30 years

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
France
Cosmin Voican
RECRUITING
Clamart
Contact Information
Primary
Cosmin Voican, Dr
cosmin.voican@aphp.fr
01 45 37 47 75
Backup
Brahim Mohamed Elarbi
brahim.mohamed-elarbi@aphp.fr
01 40 05 43 60
Time Frame
Start Date: 2022-10-01
Estimated Completion Date: 2053-02-01
Participants
Target number of participants: 1000
Treatments
Cohorte
The study will include a population of patients with excessive alcohol consumption seen in consultation or hospitalized for alcohol addiction problems and/or exploration of alcohol-related liver damage
Sponsors
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov