Exploring the role of gut bacteria in alcoholic hepatitis
Intra-Hepatic Microbiota 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.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Locations | 1 site (Lyon) |
| Trial ID | NCT06307964 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with alcoholic liver disease and clinical signs of alcoholic hepatitis.
Not a fit: Patients who have recently been treated with antibiotics or probiotics, or those with contraindications to liver biopsy, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new treatment strategies that improve survival rates and quality of life for patients with alcoholic hepatitis.
How similar studies have performed: While the involvement of gut microbiota in liver diseases has been suggested in pre-clinical studies, this specific approach to alcoholic hepatitis is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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 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 this trial is running
Lyon
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.