Cohort study on the impact of gut microbiome in alcoholic liver disease
Study of the Evolution of the Intestinal Microbiome (Taxonomic and Functional Composition) During Alcoholic Liver Disease
Assistance Publique - Hôpitaux de Paris · NCT05895890
This study is trying to see how the gut bacteria of heavy drinkers affects the development and worsening of alcoholic liver disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris (other) |
| Locations | 1 site (Clamart, Île-de-France Region) |
| Trial ID | NCT05895890 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the role of the intestinal microbiome in the development and progression of alcoholic liver disease (ALD) among heavy drinkers. Participants will be recruited based on their alcohol consumption and will undergo sequential sampling of stool, saliva, and serum to analyze microbiome composition and its potential effects on liver health. The study seeks to identify factors beyond alcohol intake that contribute to the onset of conditions like acute alcoholic hepatitis and cirrhosis. By understanding these relationships, the research aims to provide insights into better management strategies for ALD.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 who consume alcohol above specified thresholds and are seeking assessment for alcoholic liver disease.
Not a fit: Patients with other causes of liver damage or serious associated pathologies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of alcoholic liver disease, potentially reducing its progression and associated complications.
How similar studies have performed: While the role of the gut microbiome in liver disease is an emerging field, this specific cohort approach is novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Clamart, Île-de-France Region
- Cosmin Voican — Clamart, Île-de-France Region, France (RECRUITING)
Study contacts
- Principal investigator: Cosmin Voican, Dr — Assistance Publique - Hôpitaux de Paris
- Study coordinator: Cosmin Voican, Dr
- Email: cosmin.voican@aphp.fr
- Phone: 01 45 37 47 75
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Alcoholic Liver Disease, Alcoholic, Liver Disease, Intestinal microbiome, Addiction, Depression