Severe Acute Alcoholic HepatitisHepathAlc-IMNCT06159244
Intestinal Microbiota Profiling in Severe Acute Alcoholic Hepatitis Patients
A study testing stool withdrawal in people with Severe Acute Alcoholic Hepatitis and Alcohol, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
In humans, alcohol-related dysbiosis exists with a decrease in bacteroides. This dysbiosis is responsible for the breakdown of the intestinal barrier by a decrease in the synthesis of protective mucus, and some proteins involved in tight junctions or a decrease in defensin (Reg3b, Reg3g) which promotes bacterial… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Severe Acute Alcoholic Hepatitis, Alcohol, Intestinal Microbiota
- What is being tested?
- stool withdrawal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 15 Nov 2023to Nov 2028
- Phase
- Interventional
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients aged from 18 to 75 years, having :
- Heavy drinker with Maddrey Score ≥ 32 : PT(second)-PT(control)x4.6+Bilirubine (mg/dl)
- Histological confirmed Alcoholic hepatitis
- Personal consent signed to the trial
- No exclusion criteria
Who cannot join
- Age < 18 years and/or > 75 years,
- Pregnancy or lactating females,
- No personal consent
- Other causes of liver disease: chronic hepatitis B (antigen HBs positive), hepatitis C (HCV RNA positive), acetaminophen hepatotoxicity, biliary obstruction, autoimmune hepatitis, primary biliary cholangitis, primary sclerosis cholangitis, alpha 1 antitrypsine deficiency, and Wilson disease.
- Uncontrolled liver complications:
- Upper gastrointestinal bleed by portal hypertension (4 days required for stable condition)
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- Active sepsis (4 days required for stable condition)
- Patient currently treated by antibiotic
- Concomitant Liver cancer (HCC) or extrahepatic malignancy
- Type 1 hepatorenal syndrome (HRS) or renal failure defined as a serum creatinine >221 μmol/L (>2.5 mg/dL) or the requirement for renal replacement therapy
- Grade 4 Hepatic Encephalopathy (HE) by West Haven criteria
- Individuals dependent on inotropic (eg, epinephrine or norepinephrine) or ventilatory support (ie, endotracheal intubation or positive-pressure ventilation)
- Disseminated intravascular coagulation
- Intestinal paralysis
- History of liver transplantation
- Other general diseases or severe conditions:
- HIV disease
- Intestinal paralysis
- Intestinal inflammatory disease (Crohn or Ulcerative colitis)
- Clostridium difficilae infection
- Clinical suspicion of pneumonia
- Uncontrolled sepsis
- Acute Alcoholic pancreatitis
- Noncontrolled alcohol withdrawal syndrome
- Cardiac or respiratory bad conditions
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
CHU Amiens Picardie
Amiens, Picardie, 80054
Eric NGUYEN KHAC, PhD, +33322668883, nguyen-khac.eric@chu-amiens.fr
About this study
Official title: Intestinal Microbiota Profiling in HAA Patients
In humans, alcohol-related dysbiosis exists with a decrease in bacteroides. This dysbiosis is responsible for the breakdown of the intestinal barrier by a decrease in the synthesis of protective mucus, and some proteins involved in tight junctions or a decrease in defensin (Reg3b, Reg3g) which promotes bacterial growth and ultimately bacterial translocation. The microbiota of a patient with alcoholic hepatitis is different from that of a patient without alcoholic hepatitis. Acute alcoholic hepatitis has a severe prognosis and corticosteroids are the only first line therapy option, with better survival at 28 days versus placebo. However, mortality remains high at 30% at 3 months, which highlights the importance of seeking intestinal microbiota profile on treatment response.
The determination of one or more intestinal microbiota signatures associated with the treatment response Corticosteroids plus FMT or Corticosteroids plus placebo will allow the clinician to have a simple and rapid test obtained in 16S RNA analysis to predict the therapeutic response and potentially the best treatment to adopt and to address medical and medico-economic stakes.
Read more
The investigators will first characterize the alcohol-induced dysbiosis by a whole microbiota sequencing in the different groups. Specific bacterial species identify by DNA sequencing should be confirmed by qPCR of 16S rDNA to determine a fingerprint of sAH microbiota. Metabolic properties of intestinal microbiota, such as production of short chain fatty acids, will be analyzed by using HPLC. In the sAH group, evolution of intestinal microbiota will be observed by shotgun DNA sequencing between the day 0 and the day 7 of corticosteroids treatment.
The analysis of sAH patients' microbiota (day 0) will allow us to obtain a non-responder profile to corticosteroids that can be used as a prognostic marker to use in the clinic. The deliverable is the bacterial fingerprint of the treatment response and its valuation is its use as a predictive tool of the response.
- Being tested
- stool withdrawal
- Keywords
- Severe acute alcoholic hepatitis, Alcohol, Intestinal Microbiota, Corticosteroids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stool withdrawalOther
stool withdrawal at day 0 and day 7
| Study group | Role | What they receive |
|---|---|---|
| sAH patients | Experimental | the recruitment of patients with sAH will be carried out from the Hepatogastroenterology Service of the University Hospital of Amiens. Receives: Other: stool withdrawal |
| Alcohol controls without liver complications | Experimental | the recruitment of alcohol controls will concern patients followed for alcohol addiction without sAH in the antecedents or evolutionary. It will be carried out by the Hospital of Roye-Montdidier. The total number of controls will be equivalent to the number of sAH patients, matched for age and sex. Receives: Other: stool withdrawal |
| Healthy non-alcoholic witnesses | Active comparator | the general population will be called with a matching on age Receives: Other: stool withdrawal |
What is being measured
The primary outcome is the main question the study is designed to answer.
variation of sample bacterial composition between the three groups
Measured: day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2023
- Study start15 Nov 2023
- Primary completionNov 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Acute Alcoholic HepatitisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Collaborators
- CH Montdidier
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06159244
- Sponsor's protocol ID
- PI2023_843_0123
- Acronym
- HepathAlc-IM
- Status last verified
- May 2025
- First submitted
- 21 Nov 2023
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intestinal Microbiota Profiling in HAA Patients
- ClinicalTrials.gov ID
- NCT06159244
- Acronym / sponsor ID
- HepathAlc-IM / PI2023_843_0123
- Keywords
- Severe acute alcoholic hepatitis, Alcohol, Intestinal Microbiota, Corticosteroids
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Collaborators
- CH Montdidier
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 6 Dec 2023 (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.
In humans, alcohol-related dysbiosis exists with a decrease in bacteroides. This dysbiosis is responsible for the breakdown of the intestinal barrier by a decrease in the synthesis of protective mucus, and some proteins involved in tight junctions or a decrease in defensin (Reg3b, Reg3g) which promotes bacterial growth and ultimately bacterial translocation. The microbiota of a patient with alcoholic hepatitis is different from that of a patient without alcoholic hepatitis. Acute alcoholic hepatitis has a severe prognosis and corticosteroids are the only first line therapy option, with better survival at 28 days versus placebo. However, mortality remains high at 30% at 3 months, which highlights the importance of seeking intestinal microbiota profile on treatment response.
The determination of one or more intestinal microbiota signatures associated with the treatment response Corticosteroids plus FMT or Corticosteroids plus placebo will allow the clinician to have a simple and rapid test obtained in 16S RNA analysis to predict the therapeutic response and potentially the best treatment to adopt and to address medical and medico-economic stakes.
The investigators will first characterize the alcohol-induced dysbiosis by a whole microbiota sequencing in the different groups. Specific bacterial species identify by DNA sequencing should be confirmed by qPCR of 16S rDNA to determine a fingerprint of sAH microbiota. Metabolic properties of intestinal microbiota, such as production of short chain fatty acids, will be analyzed by using HPLC. In the sAH group, evolution of intestinal microbiota will be observed by shotgun DNA sequencing between the day 0 and the day 7 of corticosteroids treatment.
The analysis of sAH patients' microbiota (day 0) will allow us to obtain a non-responder profile to corticosteroids that can be used as a prognostic marker to use in the clinic. The deliverable is the bacterial fingerprint of the treatment response and its valuation is its use as a predictive tool of the response.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| sAH patients | Experimental | Other: stool withdrawalthe recruitment of patients with sAH will be carried out from the Hepatogastroenterology Service of the University Hospital of Amiens. |
| Alcohol controls without liver complications | Experimental | Other: stool withdrawalthe recruitment of alcohol controls will concern patients followed for alcohol addiction without sAH in the antecedents or evolutionary. It will be carried out by the Hospital of Roye-Montdidier. The total number of controls will be equivalent to the number of sAH patients, matched for age and sex. |
| Healthy non-alcoholic witnesses | Active comparator | Other: stool withdrawalthe general population will be called with a matching on age |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged from 18 to 75 years, having :
- Heavy drinker with Maddrey Score ≥ 32 : PT(second)-PT(control)x4.6+Bilirubine (mg/dl)
- Histological confirmed Alcoholic hepatitis
- Personal consent signed to the trial
- No exclusion criteria
Key exclusion criteria (25 listed)
- Age < 18 years and/or > 75 years,
- Pregnancy or lactating females,
- No personal consent
- Other causes of liver disease: chronic hepatitis B (antigen HBs positive), hepatitis C (HCV RNA positive), acetaminophen hepatotoxicity, biliary obstruction, autoimmune hepatitis, primary biliary cholangitis, primary sclerosis cholangitis, alpha 1 antitrypsine deficiency, and Wilson disease.
- Uncontrolled liver complications:
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 |
|---|---|---|
| stool withdrawalstool withdrawal at day 0 and day 7 | Other | Alcohol controls without liver complications, Healthy non-alcoholic witnesses, sAH patients |
Primary outcome
variation of sample bacterial composition between the three groups
Time frame: day 7
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 25 May 2025.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing stool withdrawal in people with Severe Acute Alcoholic Hepatitis and Alcohol, run by Centre Hospitalier Universitaire, Amiens 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 5 inclusion and 25 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 25 May 2025. 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 Eric Nguyen-Khac, Pr (0322088851, nguyen-khac.eric@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
variation of sample bacterial composition between the three groups (time frame: day 7). 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 25 May 2025.