Profiling gut bacteria in patients with severe alcoholic hepatitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the intestinal microbiota profiles of patients suffering from severe acute alcoholic hepatitis. It aims to identify specific microbiota signatures that may correlate with treatment responses to corticosteroids, either alone or in combination with fecal microbiota transplantation (FMT). By analyzing these profiles, the study seeks to enhance understanding of how gut bacteria influence the effectiveness of corticosteroid therapy in this patient population. The ultimate goal is to provide clinicians with rapid and simple tools to predict treatment outcomes based on microbiota composition.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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

Where it's running

• CHU Amiens Picardie
  Amiens, Picardie, France Recruiting

Study contacts

• Study coordinator: Eric Nguyen-Khac, Pr
• Email: nguyen-khac.eric@chu-amiens.fr
• Phone: 0322088851

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.