NCT07644936

Brief 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

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
24mo left

Started Jul 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 8, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 12, 2026

Completed
19 days until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Last Updated

June 12, 2026

Status Verified

June 1, 2026

Enrollment Period

1 year

First QC Date

June 8, 2026

Last Update Submit

June 8, 2026

Conditions

Autoimmune HepatitisNon-Alcoholic Fatty Liver Disease

Keywords

autoimmune hepatitislipidomic analysisextracellular vesiclesfatty acidsbiomarkersNAFLD

Outcome Measures

Primary Outcomes (1)

  • Lipidomic profile

    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)

Secondary Outcomes (3)

  • Extracellular vesicle characterization

    At enrollment (single time point - baseline blood draw)

  • Autoimmune biomarkers

    At enrollment (single time point - baseline blood draw)

  • Molecular pathways in AIH pathogenesis

    At enrollment (single time point - baseline blood draw)

Study Arms (2)

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".

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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:

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS "S. de Bellis" - Nutritional Biochemistry Lab

Castellana Grotte, Bari, 70013, Italy

Location

Related Publications (3)

  • Muratori L, Lohse AW, Lenzi M. Diagnosis and management of autoimmune hepatitis. BMJ. 2023 Feb 6;380:e070201. doi: 10.1136/bmj-2022-070201.

    PMID: 36746473BACKGROUND

  • Nishikawa H, Kim SK, Asai A. Autoimmune Hepatitis and Drug-Induced Liver Injury in Japan. J Clin Med. 2025 Jun 25;14(13):4514. doi: 10.3390/jcm14134514.

    PMID: 40648888BACKGROUND

  • Longhi MS, Zhang L, Mieli-Vergani G, Vergani D. Can we cure autoimmune hepatitis? Curr Opin Immunol. 2025 Oct;96:102609. doi: 10.1016/j.coi.2025.102609. Epub 2025 Jul 14.

    PMID: 40663808BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, serum samples. Blood samples will be collected by venipuncture. An aliquot of residual samples at the end of the analyses will be stored in the Institutional Biobank.

MeSH Terms

Conditions

Hepatitis, AutoimmuneNon-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Hepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesAutoimmune DiseasesImmune System DiseasesFatty Liver

Central Study Contacts

Maria Notarnicola, biologyst

CONTACT

+39 0804994623maria.notarnicola@irccsdebellis.it

Valentina De Nunzio

CONTACT

+39 0804994623valentina.denunzio@irccsdebellis.it

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2026

First Posted

June 12, 2026

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2028

Last Updated

June 12, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)