CirrhosisHepMAHNCT06307964
Intra-Hepatic Microbiota in Alcoholic Hepatitis
An observational study of Cirrhosis and Alcoholic Liver Disease, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhosis, Alcoholic Liver Disease, Alcoholic Hepatitis
- What is being tested?
- Biological sampling
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 23 Jul 2024to 23 Jul 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A prospective observational multicentric cohort will be conducted at Croix Rousse Hospital (Lyon, France), in the Hepatology and Intensive Care Units. Fifty consecutive patients hospitalized in either of these units for clinical suspicion of alcoholic hepatitis and indication for transjugular liver biopsy will be included.
Who may be able to join
- 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;
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hospices Civils de Lyon, Croix Rousse Hospital
Lyon
François VILLERET, MD, PhD, 0426109382 ext. +33, francois.villeret@chu-lyon.fr
About this study
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 contributes to local and systemic inflammation, hepatocyte death and fibrogenesis. However, the intrahepatic microbial environment has never been characterized in HA.
Read more
The study hypothesis is that the intrahepatic microbiota is modulated by bacterial translocation and is associated with clinical outcomes.
The aim of this study is to determine the composition of the intrahepatic (obtained from transjugular liver biopsy), blood and fecal microbiota in patients with suspected severe AH from a monocentric prospective cohort in the Hepatology Department at Croix-Rousse Hospital (Lyon). Fifty consecutive patients with clinical suspicion of AH and indication for transjugular liver biopsy will be included. About thirty-five patients are expected in the confirmed AH group, and 15 in the group "alcoholic liver disease with no AH", based on data from the literature. The composition of the various microbiota will be determined by sequencing the 16S rRNA gene, and the results will be correlated with clinical data (corticosteroid sensitivity, overall survival, transplant-free survival, MELD score in particular) and histological data.
This exploratory study will enable to analyze the intra-hepatic microbiota, and to study its link with intra-hepatic inflammation and the clinical course of patients with AH. The data generated by HepMAH will thus help identify potential new therapeutic targets linked to the gut microbiota, and provide a scientific basis for the development of therapeutic interventions targeting the microbiota in HA.
- Conditions
- Cirrhosis, Alcoholic Liver Disease, Alcoholic Hepatitis
- Being tested
- Biological sampling
- Keywords
- alcoholic hepatis, bacterial translocation, microbiota, 16S rRNA, intra-hepatic microbiota, cirrhosis, alcoholic liver disease
- Medical subject headings
- Fibrosis, Liver Diseases, Alcoholic, Hepatitis, Alcoholic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological samplingProcedure or surgery
- A fragment of the diagnostic transjugular liver biopsy (D0)
- Plasma samples at D0, and at 1 and 6 months after liver biopsy if possible
- Fecal samples at D0, and at 1 and 6 months after liver biopsy if possible
| Study group | Role | What they receive |
|---|---|---|
| Alcoholic hepatitis | Patients with histologically proven AH (after transjugular liver biopsy procedure and histological assessment). Receives: Procedure: Biological sampling | |
| No alcoholic hepatitis | Patients with initially suspected AH (excessive alcohol consumption and modified Maddrey score > 32) but no AH at the histological evaluation of liver biopsy.
It corresponds to patients with decompensated alcoholic liver disease but no AH. Receives: Procedure: Biological sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiota composition
Intrahepatic, blood and fecal microbiota composition will be assessed by 16S rRNA sequencing (MiSeq Illumina). Microbiota analysis will be performed on the fragment of transjugular liver biopsy collected for the purpose of the study, and on plasma and fecal samples after bacterial DNA extraction.
Bioinformatics analysis will be carried out using Qiime2, LeFSE (Conda) and the Maaslin2 package (v3.16; R software). Microbiota profiles determined at the genus taxonomic level will be compared between the two groups (proven AH and no AH).
Measured: At Day 0, 1 month and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start23 Jul 2024
- Primary completion23 Jan 2028 (estimated)
- Study completion23 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François VILLERET, M.D., Ph.D., Study chair, Hospices Civils de Lyon, Croix Rousse Hospital, Hepatology department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06307964
- Sponsor's protocol ID
- 69HCL23_1137
- Other IDs
- ID-RCB
- Acronym
- HepMAH
- Status last verified
- Jan 2026
- First submitted
- 6 Mar 2024
- Last updated
- 10 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-Hepatic Microbiota in Alcoholic Hepatitis
- ClinicalTrials.gov ID
- NCT06307964
- Acronym / sponsor ID
- HepMAH / 69HCL23_1137
- Conditions
- Cirrhosis, Alcoholic Liver Disease, Alcoholic Hepatitis
- Keywords
- alcoholic hepatis, bacterial translocation, microbiota, 16S rRNA, intra-hepatic microbiota, cirrhosis, alcoholic liver disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 23 Jul 2024 (actual)
- Primary completion
- 23 Jan 2028 (estimated)
- Study completion
- 23 Jul 2028 (estimated)
- First posted
- 13 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 contributes to local and systemic inflammation, hepatocyte death and fibrogenesis. However, the intrahepatic microbial environment has never been characterized in HA.
The study hypothesis is that the intrahepatic microbiota is modulated by bacterial translocation and is associated with clinical outcomes.
The aim of this study is to determine the composition of the intrahepatic (obtained from transjugular liver biopsy), blood and fecal microbiota in patients with suspected severe AH from a monocentric prospective cohort in the Hepatology Department at Croix-Rousse Hospital (Lyon). Fifty consecutive patients with clinical suspicion of AH and indication for transjugular liver biopsy will be included. About thirty-five patients are expected in the confirmed AH group, and 15 in the group "alcoholic liver disease with no AH", based on data from the literature. The composition of the various microbiota will be determined by sequencing the 16S rRNA gene, and the results will be correlated with clinical data (corticosteroid sensitivity, overall survival, transplant-free survival, MELD score in particular) and histological data.
This exploratory study will enable to analyze the intra-hepatic microbiota, and to study its link with intra-hepatic inflammation and the clinical course of patients with AH. The data generated by HepMAH will thus help identify potential new therapeutic targets linked to the gut microbiota, and provide a scientific basis for the development of therapeutic interventions targeting the microbiota in HA.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alcoholic hepatitis | – | Procedure: Biological samplingPatients with histologically proven AH (after transjugular liver biopsy procedure and histological assessment). |
| No alcoholic hepatitis | – | Procedure: Biological samplingPatients with initially suspected AH (excessive alcohol consumption and modified Maddrey score > 32) but no AH at the histological evaluation of liver biopsy. It corresponds to patients with decompensated alcoholic liver disease but no AH. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A prospective observational multicentric cohort will be conducted at Croix Rousse Hospital (Lyon, France), in the Hepatology and Intensive Care Units. Fifty consecutive patients hospitalized in either of these units for clinical suspicion of alcoholic hepatitis and indication for transjugular liver biopsy will be included.
Key inclusion criteria (3 listed)
- 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;
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biological sampling* A fragment of the diagnostic transjugular liver biopsy (D0) * Plasma samples at D0, and at 1 and 6 months after liver biopsy if possible * Fecal samples at D0, and at 1 and 6 months after liver biopsy if possible | Procedure or surgery | Alcoholic hepatitis, No alcoholic hepatitis |
Primary outcome
Microbiota composition
Time frame: At Day 0, 1 month and 6 months
Intrahepatic, blood and fecal microbiota composition will be assessed by 16S rRNA sequencing (MiSeq Illumina). Microbiota analysis will be performed on the fragment of transjugular liver biopsy collected for the purpose of the study, and on plasma and fecal samples after bacterial DNA extraction. Bioinformatics analysis will be carried out using Qiime2, LeFSE (Conda) and the Maaslin2 package (v3.16; R software). Microbiota profiles determined at the genus taxonomic level will be compared between the two groups (proven AH and no AH).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
François VILLERET, M.D., Ph.D. study chair
Hospices Civils de Lyon, Croix Rousse Hospital, Hepatology department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cirrhosis and Alcoholic Liver Disease, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact François VILLERET, M.D., Ph.D. (+33426109382, francois.villeret@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiota composition (time frame: At Day 0, 1 month and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.