Actively Recruiting
Intestinal Microbiota Profiling in Severe Acute Alcoholic Hepatitis Patients
Led by Centre Hospitalier Universitaire, Amiens · Updated on 2025-05-25
200
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
C
Centre Hospitalier Universitaire, Amiens
Lead Sponsor
C
CH Montdidier
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the intestinal microbiota in patients with severe acute alcoholic hepatitis (sAH), a serious liver condition linked to alcohol-related changes in gut bacteria. The study aims to identify specific bacterial patterns associated with how patients respond to corticosteroid treatment combined with either fecal microbiota transplantation (FMT) or placebo. Understanding these bacterial fingerprints may help predict treatment outcomes and guide personalized therapy. Participants include three groups: sAH patients, alcohol-dependent controls without liver complications, and healthy non-alcoholic individuals, matched by age and sex. The study involves collecting stool samples at the start and after seven days to analyze bacterial composition using advanced DNA sequencing techniques. Researchers will assess changes in microbiota and metabolic products like short-chain fatty acids, aiming to characterize dysbiosis linked to alcohol use and treatment response. During the study, stool samples will be collected at baseline and day 7. Researchers will analyze microbial DNA to compare bacterial composition changes between groups and evaluate metabolic activity. The main outcome is the variation in bacterial composition after one week of corticosteroid treatment. The study is double-blinded and non-randomized, with a participation age range of 18 to 75 years. The trial is sponsored by Centre Hospitalier Universitaire, Amiens, and includes healthy volunteers for comparison.
CONDITIONS
Brief Title
Intestinal Microbiota Profiling in Severe Acute Alcoholic Hepatitis Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged from 18 to 75 years
- Heavy drinkers with Maddrey Score ≥ 32
- Histologically confirmed diagnosis of alcoholic hepatitis
- Signed personal consent to participate
- No exclusion criteria present
You will not qualify if you...
- Age below 18 years or above 75 years
- Pregnancy or breastfeeding
- No personal consent given
- Presence of other liver diseases such as chronic hepatitis B, hepatitis C, autoimmune hepatitis, primary biliary cholangitis, primary sclerosis cholangitis, alpha 1 antitrypsin deficiency, or Wilson disease
- Uncontrolled liver complications like recent gastrointestinal bleeding or active sepsis
- Current antibiotic treatment
- Liver cancer or other malignancies
- Severe kidney failure or type 1 hepatorenal syndrome
- Grade 4 hepatic encephalopathy
- Dependency on inotropic or ventilatory support
- Disseminated intravascular coagulation
- Intestinal paralysis
- History of liver transplantation
- HIV infection
- Intestinal inflammatory diseases such as Crohn's disease or ulcerative colitis
- Clostridium difficile infection
- Clinical suspicion of pneumonia
- Acute alcoholic pancreatitis
- Uncontrolled alcohol withdrawal syndrome
- Severe cardiac or respiratory conditions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 week
Participants provide stool samples to assess intestinal microbiota composition.
2 visits (in-person) on Day 0 and Day 7
Trial Site Locations
Total: 1 location
1
CHU Amiens Picardie
Amiens, Picardie, France, 80054
Actively Recruiting
Research Team
E
Eric Nguyen-Khac, Pr
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
3
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