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Molecular Characterization of Autoimmune Hepatitis: A Lipidomic Approach (AIH-LIPID)

14. juli 2026 oppdatert av: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

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

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Detaljert beskrivelse

Autoimmune hepatitis (AIH) is a chronic inflammatory liver disease characterized by high serum levels of transaminases and IgG immunoglobulins, presence of organ-specific and non-organ-specific autoantibodies, and interface hepatitis at histopathology. Two distinct types are recognized: AIH type 1, associated with anti-smooth muscle antibodies (SMA) and/or antinuclear antibodies (ANA); and AIH type 2, associated with anti-liver-kidney microsome type 1 (anti-LKM-1) and/or anti-liver cytosol type 1 (anti-LC-1) antibodies.

AIH presents a heterogeneous clinical picture driven by immune dysregulation involving B and T lymphocytes and macrophages. The autoimmune response is initiated by T lymphocyte recognition of self-antigens presented by MHC molecules, leading to differentiation into Th1, Th2, or Th17 cells that mediate hepatic damage.

Extracellular vesicles (EVs) have recently been implicated in AIH pathogenesis, acting as mediators of intercellular communication. EVs can carry autoantigens, signaling molecules, lipids, and nucleic acids, modulating immune responses and potentially facilitating immune tolerance disruption. In AIH, EVs may vehicle hepatic autoantigens and modulate immune cell activity in the liver.

No specific biomarkers currently exist that reliably distinguish AIH from other hepatic conditions, including NAFLD/MASLD, with which it is frequently associated due to overlapping metabolic alterations. A lipidomic approach is therefore proposed to identify specific lipid profiles associated with AIH.

Lipidomic analysis will be performed on red blood cell membranes and serum of both study arms. Extracted fatty acids will be derivatized and analyzed by gas chromatography with flame ionization detection (GC-FID), compared against the FAME Mix-37 chromatogram. EVs isolated from serum will be further characterized for potential use as biocompatible nanovectors for immunosuppressive or immunomodulatory drug delivery.

Studietype

Observasjonsmessig

Registrering (Antatt)

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Navn: Maria Notarnicola, biologyst
Telefonnummer: +39 0804994623
E-post: maria.notarnicola@irccsdebellis.it

Studer Kontakt Backup

Navn: Valentina De Nunzio
Telefonnummer: +39 0804994623
E-post: valentina.denunzio@irccsdebellis.it

Studiesteder

Italia
- Bari
  - Castellana Grotte, Bari, Italia, 70013
    - IRCCS "S. de Bellis" - Nutritional Biochemistry Lab
    - Ta kontakt med:
      
      Maria Notarnicola, Biologyst
      
      Telefonnummer: 0804994623
      
      E-post: maria.notarnicola@irccsdebellis.it
    - Ta kontakt med:
      
      Valentina De Nunzio
      
      Telefonnummer: 0804994623
      
      E-post: valentina.denunzio@irccsdebellis.it
    - Hovedetterforsker:
      
      Maria Notarnicola
    - Underetterforsker:
      
      Emanuela Aloisio Caruso
    - Underetterforsker:
      
      Valentina De Nunzio
    - Underetterforsker:
      
      Giuliano Pinto
    - Underetterforsker:
      
      Angela Tafaro
    - Underetterforsker:
      
      Maria Principia Scavo
    - Underetterforsker:
      
      Raffaele Cozzolongo
    - Underetterforsker:
      
      Endrit Shahini
    - Underetterforsker:
      
      Pasqua Letizia Pesole

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

Voksen
Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

dult outpatients with AIH or NAFLD diagnosis attending the UOSD Epatopatie at IRCCS "S. de Bellis", Castellana Grotte (BA), Italy

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Antall grupper / kohorter

Kohorter og intervensjoner

Gruppe / Kohort
Arm A - Autoimmune Hepatitis (AIH) 12 adult outpatients with a confirmed diagnosis of autoimmune hepatitis (AIH), attending the Hepatology Outpatient Unit (UOSD Epatopatie) of IRCCS "S. de Bellis".
Arm B - Non-Alcoholic Fatty Liver Disease (NAFLD) 12 adult outpatients with a confirmed diagnosis of non-alcoholic fatty liver disease (NAFLD), attending the Hepatology Outpatient Unit (UOSD Epatopatie) of IRCCS "S. de Bellis".

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Lipidomic profile Tidsramme: At enrollment (single time point - baseline blood draw)	Identification of specific lipid profiles (fatty acid composition) on red blood cell membranes and serum associated with AIH compared to NAFLD, assessed by gas chromatography with flame ionization detection (GC-FID).	At enrollment (single time point - baseline blood draw)

Sekundære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Number and size distribution of serum-derived extracellular vesicles assessed by nanoparticle tracking analysis (NTA) Tidsramme: At enrollment (single time point - baseline blood draw)	Isolation and characterization of EVs from patient serum to evaluate their use as biocompatible nanovectors for immunosuppressive/immunomodulatory drug delivery	At enrollment (single time point - baseline blood draw)
Concentration of serum lipidomic and biochemical biomarkers for AIH diagnosis assessed by integrated lipidomic and biochemical analysis Tidsramme: At enrollment (single time point - baseline blood draw)	Identification of molecular biomarkers for early and accurate AIH diagnosis through integrated lipidomic and biochemical analysis	At enrollment (single time point - baseline blood draw)
Expression profile of EV-associated proteins and miRNAs involved in AIH pathogenesis assessed by proteomic and transcriptomic analysis Tidsramme: At enrollment (single time point - baseline blood draw)	Identification of molecular pathways involved in AIH pathogenesis through EV characterization	At enrollment (single time point - baseline blood draw)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. juli 2026

Primær fullføring (Antatt)

1. juli 2027

Studiet fullført (Antatt)

1. juli 2028

Datoer for studieregistrering

Først innsendt

8. juni 2026

Først innsendt som oppfylte QC-kriteriene