← Back to all trials
Not Yet Recruiting
NCT07644936
Molecular Characterization of Autoimmune Hepatitis: A Lipidomic Approach
Conditions: Autoimmune Hepatitis, Non-Alcoholic Fatty Liver Disease
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 24
Sponsor: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Location: IRCCS "S. de Bellis" - Nutritional Biochemistry Lab Castellana Grotte Bari
Summary
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
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
* Confirmed diagnosis of non-alcoholic fatty liver disease (NAFLD);
* Adult age (≥18 years);
* Ability to provide written informed consent; Attending the Hepatology Outpatient Unit of IRCCS "S. de Bellis"
Esclusion Criteria:
* Liver cirrhosis;
* Active oncological diseases;
* Viral hepatitis (HBV, HCV, HIV infection);
* Severe medical conditions that may compromise study participation
Source: ClinicalTrials.gov (NCT07644936). StuddyBuddy aggregates publicly available trial information.
