GENESIS: Qualitative gut microbiome assessment and the role of faecal microbiota transplantation (FMT) on mortality in patients with severe alcoholic hepatitis

orthern Adelaide Local Health Network (NALHN)0 个研究点目标入组 40 人开始时间: 2024年8月29日最近更新: 2024年9月2日

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•Individuals meeting the clinical and biochemical criteria for severe alcoholic hepatitis as defined by:
•1)Rapid development or worsening jaundice and liver related complications
•2)Serum total bilirubin > 80 mmol/L, ALT and AST levels <400 U/L, with the AST/ALT ratio >1.5
•3)Documentation of persistent heavy alcohol use until 8 weeks before onset of symptoms
•4)Average alcohol consumption of >80g/ day for men and >60g/day for women
•5)Maddrey’s Discriminant Function (DF) score greater than or equal to 32 AND MELD score 21-30
•Liver biopsy is not required to confirm the diagnosis of severe alcoholic hepatitis.

•1)Cessation of alcohol consumption for >2 months prior to randomization
•2)Concomitant liver disease including viral hepatitis, autoimmune hepatitis, drug induced liver injury, acute pancreatitis, HIV and active tuberculosis
•3)High grade encephalopathy requiring endotracheal intubation for airway support
•4)Uncontrolled upper gastrointestinal bleeding
•5)Acute kidney injury (AKI) or hepato-renal syndrome (HRS) with serum creatinine >500 mmol/L or requirement for renal replacement therapy
•6)Hepatic or extrahepatic malignancy
•7)Pregnancy or nursing
•8)Uncontrolled infections or sepsis
•9)Anaphylactic food allergy
•10) Prebiotic, probiotic or antibiotic use within 4 weeks of enrolment
•11) Participant unable to provide informed consent

发起方

orthern Adelaide Local Health Network (NALHN)