Cohort study on the impact of gut microbiome in alcoholic liver disease
Official title: Study of the Evolution of the Intestinal Microbiome (Taxonomic and Functional Composition) During Alcoholic Liver Disease
Run by Assistance Publique - Hôpitaux de Paris · NCT05895890 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 1000 (estimated) |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Clamart, Île-de-France Region) |
| Status | Recruiting |
| Started | October 1, 2022 |
| Main results expected | February 1, 2043 |
| Study ends | February 1, 2053 |
| Registry record updated | July 6, 2023 |
| Trial ID | NCT05895890 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 to 75 who consume alcohol above specified thresholds and are seeking assessment for alcoholic liver disease.
✕Probably not a fit
Patients with other causes of liver damage or serious associated pathologies may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Exploring the role of gut bacteria in alcoholic hepatitis
This study is trying to see how gut bacteria affect liver damage in people with severe alcoholic hepatitis to find new ways to help them feel better.
-
Evaluating liver disease screening for individuals with alcohol use disorder
This study tests if screening for liver disease with a special measurement helps people in alcohol treatment stay sober or drink less over six months.
-
HMB supplementation for patients with alcoholic liver disease and COVID-19
This study is testing if HMB supplements can help people with alcoholic liver disease who also have COVID-19 feel better and recover more effectively.
-
Improving early diagnosis of liver disease using integrated diagnostics
This study is trying to improve how quickly and accurately liver disease is diagnosed by combining different tests and information from around 750 patients who are at risk or have abnormal liver blood tests.
-
Understanding Alcohol-related Liver Disease in Europe
This study looks at how alcohol-related liver disease develops in heavy drinkers to see if non-invasive tests can help identify those at risk of serious liver damage.
-
Effects of a fermented powder on liver disease caused by alcohol
This study is testing if a special fermented powder can help adults with liver disease caused by alcohol feel better over eight weeks.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.