Clinical trial Recruiting at 1 site Observational Ages 18 to 75

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.

More Alcoholic Liver Disease trials

Quick facts

Study typeObservational
Ages18 Years to 75 Years
SexAll
Enrollment1000 (estimated)
SponsorAssistance Publique - Hôpitaux de Paris
Academic / other
Locations1 site (Clamart, Île-de-France Region)
StatusRecruiting
StartedOctober 1, 2022
Main results expectedFebruary 1, 2043
Study endsFebruary 1, 2053
Registry record updatedJuly 6, 2023
Trial IDNCT05895890 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

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.