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

8. juni 2026 opdateret af: 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

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Detaljeret 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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

24

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Italien
    • Bari
      • Castellana Grotte, Bari, Italien, 70013
        • IRCCS "S. de Bellis" - Nutritional Biochemistry Lab
        • Kontakt:
        • Kontakt:
        • Ledende efterforsker:
          • Maria Notarnicola
        • Underforsker:
          • Emanuela Aloisio Caruso
        • Underforsker:
          • Valentina De Nunzio
        • Underforsker:
          • Giuliano Pinto
        • Underforsker:
          • Angela Tafaro
        • Underforsker:
          • Maria Principia Scavo
        • Underforsker:
          • Raffaele Cozzolongo
        • Underforsker:
          • Endrit Shahini
        • Underforsker:
          • Pasqua Letizia Pesole

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
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".

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
Tidsramme
Extracellular vesicle characterization
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)
Autoimmune biomarkers
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)
Molecular pathways in AIH pathogenesis
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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juli 2026

Primær færdiggørelse (Anslået)

1. juli 2027

Studieafslutning (Anslået)

1. juli 2028

Datoer for studieregistrering

Først indsendt

8. juni 2026

Først indsendt, der opfyldte QC-kriterier

8. juni 2026

Først opslået (Faktiske)

12. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • PR-23-26-NOTARNICOLA

Plan for individuelle deltagerdata (IPD)

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INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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