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Search / Trial NCT06307964

Intra-Hepatic Microbiota in Alcoholic Hepatitis

Launched by HOSPICES CIVILS DE LYON · Mar 6, 2024

Trial Information

Current as of July 25, 2025

Recruiting

Keywords

Alcoholic Hepatis Bacterial Translocation Microbiota 16 S R Rna Intra Hepatic Microbiota Cirrhosis Alcoholic Liver Disease

ClinConnect Summary

This clinical trial is focusing on understanding the role of bacteria in the liver of patients suffering from alcoholic hepatitis (AH), a serious condition related to alcoholic liver disease. Researchers want to learn how the bacteria in the liver, blood, and gut might affect the severity of AH and patient outcomes. They will study 50 patients who have been diagnosed with alcoholic liver disease and show signs of AH. By analyzing the types of bacteria present, they hope to find new ways to treat this condition, especially since current treatments only work for some patients.

To be eligible for this study, participants must be at least 18 years old and have alcoholic liver disease with signs of AH, such as jaundice and heavy alcohol use. They should also be scheduled for a specific kind of liver biopsy. However, those who have recently taken antibiotics or probiotics, are pregnant, or have certain medical conditions may not be able to participate. If you join the study, you can expect to have a liver biopsy and provide samples for analysis, helping researchers gather important information that could lead to better treatments for AH in the future.

Gender

ALL

Eligibility criteria

  • 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 have been treated with antibiotics or probiotics within the last 15 days prior to liver biopsy, with the exception of antibiotics used for 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)

About Hospices Civils De Lyon

Hospices Civils de Lyon (HCL) is a leading public health institution in France, dedicated to providing high-quality healthcare and advancing medical research. With a rich history dating back to the 18th century, HCL encompasses multiple hospitals and offers a diverse range of services across various medical specialties. The institution is committed to fostering innovative clinical trials that aim to enhance patient care and improve therapeutic outcomes. By collaborating with academic and industry partners, HCL plays a pivotal role in the development of new treatments and the advancement of medical knowledge, ensuring that research efforts are aligned with the highest ethical standards and patient safety protocols.

Locations

Lyon, , France

Patients applied

0 patients applied

Trial Officials

Yasmina CHOUIK, M.D., Ph.D.

Study Chair

Hospices Civils de Lyon, Croix Rousse Hospital, Hepatology department

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported