Autoimmune HepatitisAIH-LIPIDNCT07644936
Molecular Characterization of Autoimmune Hepatitis: A Lipidomic Approach
An observational study of Autoimmune Hepatitis and Non-Alcoholic Fatty Liver Disease, run by Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autoimmune Hepatitis, Non-Alcoholic Fatty Liver Disease
- How many people
- 24 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2026to 1 Jul 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: dult outpatients with AIH or NAFLD diagnosis attending the UOSD Epatopatie at IRCCS "S. de Bellis", Castellana Grotte (BA), Italy
Who may be able to join
- 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:
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
IRCCS "S. de Bellis" - Nutritional Biochemistry Lab
Castellana Grotte, Bari, 70013
Maria Notarnicola, Biologyst, 0804994623, maria.notarnicola@irccsdebellis.it
Valentina De Nunzio, 0804994623, valentina.denunzio@irccsdebellis.it
About this study
Official title: 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
Read the detailed description
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.
- Keywords
- autoimmune hepatitis, lipidomic analysis, extracellular vesicles, fatty acids, biomarkers, NAFLD
- Medical subject headings
- Hepatitis, Autoimmune, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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". |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At enrollment (single time point - baseline blood draw)
Secondary outcomes (3)
Number and size distribution of serum-derived extracellular vesicles assessed by nanoparticle tracking analysis (NTA)
Isolation and characterization of EVs from patient serum to evaluate their use as biocompatible nanovectors for immunosuppressive/immunomodulatory drug delivery
Measured: 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
Identification of molecular biomarkers for early and accurate AIH diagnosis through integrated lipidomic and biochemical analysis
Measured: 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
Identification of molecular pathways involved in AIH pathogenesis through EV characterization
Measured: At enrollment (single time point - baseline blood draw)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Autoimmune HepatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07644936
- Sponsor's protocol ID
- PR-23-26-NOTARNICOLA
- Acronym
- AIH-LIPID
- Status last verified
- Jul 2026
- First submitted
- 8 Jun 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Muratori L, Lohse AW, Lenzi M. Diagnosis and management of autoimmune hepatitis. BMJ. 2023 Feb 6;380:e070201. doi: 10.1136/bmj-2022-070201.
PubMed 36746473Nishikawa 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.
PubMed 40648888Longhi 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.
PubMed 40663808
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Characterization of Autoimmune Hepatitis Through Lipidomic Analysis and Extracellular Vesicle Profiling: A Controlled Pilot Clinical Study
- ClinicalTrials.gov ID
- NCT07644936
- Acronym / sponsor ID
- AIH-LIPID / PR-23-26-NOTARNICOLA
- Keywords
- autoimmune hepatitis, lipidomic analysis, extracellular vesicles, fatty acids, biomarkers, NAFLD
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de BellisUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 12 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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". |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- dult outpatients with AIH or NAFLD diagnosis attending the UOSD Epatopatie at IRCCS "S. de Bellis", Castellana Grotte (BA), Italy
Key inclusion criteria (5 listed)
- 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"
Key exclusion criteria (8 listed)
- 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"
- Liver cirrhosis;
- Active oncological diseases;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Lipidomic profile
Time frame: 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).
3 secondary outcomes
Number and size distribution of serum-derived extracellular vesicles assessed by nanoparticle tracking analysis (NTA)
Time frame: 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
Time frame: 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
Time frame: At enrollment (single time point - baseline blood draw)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Background: PubMed 36746473Muratori L, Lohse AW, Lenzi M. Diagnosis and management of autoimmune hepatitis. BMJ. 2023 Feb 6;380:e070201. doi: 10.1136/bmj-2022-070201.
- Background: PubMed 40648888Nishikawa 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.
- Background: PubMed 40663808Longhi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autoimmune Hepatitis and Non-Alcoholic Fatty Liver Disease, run by Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria Notarnicola, biologyst (+39 0804994623, maria.notarnicola@irccsdebellis.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lipidomic profile (time frame: At enrollment (single time point - baseline blood draw)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07644936, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.