Exploring the role of gut bacteria in alcoholic hepatitis

Is this trial a fit for you?

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 investigates the intra-hepatic microbiota in patients with alcoholic hepatitis, a severe complication of alcoholic liver disease. It aims to understand how bacterial translocation from the gut to the liver contributes to inflammation and liver damage. Patients with a modified Maddrey score of 32 or higher, indicating severe alcoholic hepatitis, will undergo diagnostic transjugular liver biopsy for biological sampling. The study seeks to identify new therapeutic targets to improve outcomes for patients suffering from this condition.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients suffering from alcoholic liver disease and clinical suspicion of alcoholic hepatitis (subacute jaundice, heavy alcohol consumption active or weaned for ≤ 3 months, modified Maddrey score ≥32) and indication for diagnostic transjugular liver biopsy;
* Non-objection obtained from the patient or trusted person in case of impaired judgment or consciousness before performing liver biopsy;
* Aged ≥ 18 years at the time of study entry;

Exclusion Criteria:

* Patients who were treated with antibiotics or probiotics between the 15th day and 72 hours prior to liver biopsy, with the exception of antibiotics used for the prophylaxis of ascites infection or hepatic encephalopathy
* Contraindication to transjugular liver biopsy (hepatocellular carcinoma on predicted puncture site)
* Pregnant, parturient or breast-feeding women
* Persons deprived of their liberty by judicial or administrative decision
* Adults under legal protection (guardianship, curators)

Where it's running

• Hospices Civils de Lyon, Croix Rousse Hospital
  Lyon, France Recruiting

Study contacts

• Study coordinator: François VILLERET, M.D., Ph.D.
• Email: francois.villeret@chu-lyon.fr
• Phone: +33426109382

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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.