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Intra-Hepatic Microbiota in Alcoholic Hepatitis

Recruitingn/aAges 18 Years - anyAllHospices Civils de Lyon
NCT06307964 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Alcoholic hepatitis (AH) is a serious complication of alcoholic liver disease (ALD). The histological presentation of AH is characterized by neutrophilic lobular inflammation, macrovesicular steatosis, hepatocyte ballooning and necrosis and the presence of Mallory bodies. In cases of severe HA, defined by a modified Maddrey score of 32 or above, mortality at 1 month is estimated at between 10 and 50%. The only treatment to reduce early mortality is corticosteroid therapy. However, only 60% of patients respond to corticosteroids, and no benefit has been demonstrated on late mortality. Identifying new therapeutic targets is therefore a major challenge in this disease. Numerous pre-clinical studies and human data suggest the involvement of the intestinal microbiota in the pathogenesis of AH. Translocation of viable bacteria and microbial products from the digestive tract to the liver contr

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📋 Eligibility rules (as published)
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)
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What it tests

  • Biological sampling
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Where

1 site
Hospices Civils de Lyon, Croix Rousse Hospital
Lyon, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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