Profiling gut bacteria in patients with severe alcoholic hepatitis
Intestinal Microbiota Profiling in HAA Patients
This study is testing if the types of gut bacteria in patients with severe alcoholic hepatitis can help predict how well they respond to corticosteroid treatment, with or without fecal microbiota transplantation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire, Amiens Academic / other |
| Locations | 1 site (Amiens, Picardie) |
| Trial ID | NCT06159244 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 75 with a confirmed diagnosis of severe acute alcoholic hepatitis and a high Maddrey score.
Not a fit: Patients with other liver diseases, uncontrolled liver complications, or those outside the age range may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for patients with severe alcoholic hepatitis, potentially enhancing survival rates.
How similar studies have performed: While the specific approach of profiling intestinal microbiota in this context may be novel, there is growing interest in the role of gut bacteria in liver diseases, suggesting potential for success based on related research.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Amiens, Picardie
- CHU Amiens Picardie — Amiens, Picardie, France (Recruiting)
Study contacts
- Study coordinator: Eric Nguyen-Khac, Pr
- Email: nguyen-khac.eric@chu-amiens.fr
- Phone: 0322088851
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.