Status:
RECRUITING
Intestinal Microbiota Profiling in Severe Acute Alcoholic Hepatitis Patients
Lead Sponsor:
Centre Hospitalier Universitaire, Amiens
Collaborating Sponsors:
CH Montdidier
Conditions:
Severe Acute Alcoholic Hepatitis
Alcohol
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
- 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
Key Trial Info
Start Date :
November 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2028
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06159244
Start Date
November 15 2023
End Date
November 1 2028
Last Update
May 25 2025
Active Locations (1)
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1
CHU Amiens Picardie
Amiens, Picardie, France, 80054