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Studying fats and tiny blood particles in autoimmune hepatitis compared with fatty liver disease

Compares blood fat patterns in adults with autoimmune hepatitis and fatty liver disease.

Plain-language title generated from the registry record
Registry title: Molecular Characterization of Autoimmune Hepatitis: A Lipidomic Approach

Key facts

Where
Castellana Grotte, ItalySee the site

Where in Italy

  • IRCCS "S. de Bellis" - Nutritional Biochemistry LabCastellana Grotte, ItalyNo longer taking part

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Trial details

Who runs it
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Trial code
NCT07644936
Record updated
15 July 2026
Original description
This is a two-arm, prospective, controlled observational pilot clinical study aimed at characterizing the lipidomic profile and extracellular vesicles (EVs) of patients with autoimmune hepatitis (AIH) compared to patients with non-alcoholic fatty liver disease (NAFLD). A total of 24 adult outpatients will be enrolled at the Hepatology Outpatient Unit of IRCCS "S. de Bellis". Blood samples will be collected by venipuncture to perform lipidomic analyses on red blood cell membranes and serum, and to isolate and characterize EVs. No intervention beyond standard clinical practice will be appliedRead full original descriptionShow less

Molecular Characterization of Autoimmune Hepatitis Through Lipidomic Analysis and Extracellular Vesicle Profiling: A Controlled Pilot Clinical Study

This is a two-arm, prospective, controlled observational pilot clinical study aimed at characterizing the lipidomic profile and extracellular vesicles (EVs) of patients with autoimmune hepatitis (AIH) compared to patients with non-alcoholic fatty liver disease (NAFLD). A total of 24 adult outpatients will be enrolled at the Hepatology Outpatient Unit of IRCCS "S. de Bellis". Blood samples will be collected by venipuncture to perform lipidomic analyses on red blood cell membranes and serum, and to isolate and characterize EVs. No intervention beyond standard clinical practice will be applied

Inclusion: ARM A:; Confirmed diagnosis of autoimmune hepatitis (AIH); Adult age (≥18 years); Ability to provide written informed consent; Attending the Hepatology Outpatient Unit of IRCCS "S. de Bellis"; ARM B:.

Exclusion: Confirmed diagnosis of non-alcoholic fatty liver disease (NAFLD); Active oncological diseases; Viral hepatitis (HBV, HCV, HIV infection); Severe medical conditions that may compromise study participation; Adult age (≥18 years); Ability to provide written informed consent; Attending the Hepatology Outpatient Unit of IRCCS "S. de Bellis"; Esclusion Criteria:; Liver cirrhosis.

ClinicalTrials.gov NCT07644936