IgA VasculitisIFABP-IgAVNCT07664228
I-FABP as a Predictor of Gastrointestinal Involvement in Pediatric IgA Vasculitis
An observational study of IgA Vasculitis and Gastrointestinal Involvement, run by Bursa City Hospital at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational study aims to evaluate plasma intestinal fatty acid-binding protein (I-FABP) levels in children with IgA vasculitis and investigate their association with gastrointestinal involvement. Blood samples will be collected at diagnosis and during follow-up 2-4 weeks later. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- IgA Vasculitis, Gastrointestinal Involvement
- What is being tested?
- Plasma I-FABP Measurement
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2026to 15 May 2027
- 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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children aged 2-18 years with newly diagnosed IgA vasculitis who are followed at a tertiary pediatric rheumatology center. Participants will be prospectively evaluated for gastrointestinal involvement and plasma I-FABP levels at diagnosis and during routine follow-up approximately 2-4 weeks later.
Who may be able to join
- Diagnosis of IgA vasculitis (Henoch-Schönlein purpura) according to EULAR/PRINTO/PRES classification criteria.
- Age between 2 and 18 years.
- Availability for blood sample collection at diagnosis (baseline visit).
- Ability to attend a routine follow-up visit approximately 2-4 weeks after diagnosis.
- Parent or legal guardian able and willing to provide written informed consent.
Who cannot join
- Refusal of informed consent by the parent/legal guardian.
- Inability to obtain a baseline blood sample.
- Inability to complete study follow-up procedures.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bursa City Hospital
Bursa, Bursa, 16250
Nur zengin, 05064767328, nszengin37@hotmail.com
About this study
Official title: The Role of Intestinal Fatty Acid Binding Protein in Predicting Gastrointestinal Involvement in Pediatric IgA Vasculitis
This prospective observational study aims to evaluate plasma intestinal fatty acid-binding protein (I-FABP) levels in children with IgA vasculitis and investigate their association with gastrointestinal involvement. Blood samples will be collected at diagnosis and during follow-up 2-4 weeks later. The study will assess the potential value of plasma I-FABP as a biomarker for gastrointestinal involvement in pediatric IgA vasculitis.
Read the detailed description
This prospective observational cohort study aims to evaluate the association between plasma intestinal fatty acid-binding protein (I-FABP) levels and gastrointestinal involvement in children with IgA vasculitis (Henoch-Schönlein purpura).
Children aged 2-18 years who fulfill the EULAR/PRINTO/PRES classification criteria for IgA vasculitis will be enrolled. Clinical, laboratory, and demographic data will be collected at diagnosis (baseline). Participants will be followed prospectively, and a second assessment will be performed during the routine follow-up visit at approximately 2-4 weeks after diagnosis.
Blood samples will be obtained at baseline and during follow-up. Plasma will be separated and stored for subsequent measurement of I-FABP levels. The primary objective is to determine whether plasma I-FABP levels are associated with the presence of gastrointestinal involvement in pediatric IgA vasculitis.
Participants will be classified according to the presence or absence of gastrointestinal involvement. Clinical manifestations, laboratory findings, and plasma I-FABP levels will be compared between groups. The study does not involve administration of investigational drugs, devices, or therapeutic interventions. All procedures are performed as part of routine clinical follow-up with additional blood sampling for biomarker analysis.
The findings may help identify noninvasive biomarkers for the early detection and assessment of gastrointestinal involvement in children with IgA vasculitis.
- Conditions
- IgA Vasculitis, Gastrointestinal Involvement
- Being tested
- Plasma I-FABP Measurement
- Keywords
- IgA Vasculitis, Henoch-Schönlein Purpura, I-FABP, Intestinal Fatty Acid Binding Protein, Gastrointestinal Involvement, Children, Pediatric Rheumatology
- Medical subject headings
- IgA Vasculitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasma I-FABP MeasurementDiagnostic test
Blood samples are collected and plasma I-FABP levels are measured to evaluate gastrointestinal involvement in pediatric IgA vasculitis.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric IgA Vasculitis Patients With Gastrointestinal Involvement | Children with IgA vasculitis and gastrointestinal involvement. Receives: Diagnostic Test: Plasma I-FABP Measurement | |
| Pediatric IgA Vasculitis Patients Without Gastrointestinal Involvement | Children with IgA vasculitis without gastrointestinal involvement. Receives: Diagnostic Test: Plasma I-FABP Measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma I-FABP Levels
Assessment of plasma I-FABP levels and their association with gastrointestinal involvement in pediatric IgA vasculitis patients.
Measured: At baseline (T0) and at follow-up 2-4 weeks after diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start15 May 2026
- Primary completion15 Feb 2027 (estimated)
- Study completion15 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for IgA VasculitisStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bursa City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Nur Şeyma Zengin, Bursa City Hospital
- Investigators
- Tuba Kurt, MD, Associate Professor, Principal investigator, Health Sciences University Bursa City Hospital, Department of Pediatric Rheumatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07664228
- Sponsor's protocol ID
- IFABP-IgAV-2026
- Acronym
- IFABP-IgAV
- Status last verified
- Jun 2026
- First submitted
- 17 Jun 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared in order to protect participant privacy and confidentiality.
Publications
Kocsis D, Papp M, Tornai T, Tulassay Z, Herszenyi L, Toth M, Juhasz M. [Intestinal fatty acid binding protein: marker of enterocyte damage in acute and chronic gastroenterological diseases]. Orv Hetil. 2016 Jan 10;157(2):59-64. doi: 10.1556/650.2016.30336. Hungarian.
PubMed 26726140Cheng S, Yu J, Zhou M, Tu Y, Lu Q. Serologic Intestinal-Fatty Acid Binding Protein in Necrotizing Enterocolitis Diagnosis: A Meta-Analysis. Biomed Res Int. 2015;2015:156704. doi: 10.1155/2015/156704. Epub 2015 Dec 22.
PubMed 26798632Sarikaya M, Ergul B, Dogan Z, Filik L, Can M, Arslan L. Intestinal fatty acid binding protein (I-FABP) as a promising test for Crohn's disease: a preliminary study. Clin Lab. 2015;61(1-2):87-91. doi: 10.7754/clin.lab.2014.140518.
PubMed 25807642Tyagunov AE, Anurov MV, Titkova SM, Kurashinova LS, Loban KM, Tyagunov AA, Sazhin AV. Intestinal fatty acid-binding protein (I-FABP) as biomarker of ischemic damage in experimentally induced 12-h small bowel obstruction. Updates Surg. 2024 Nov;76(7):2693-2700. doi: 10.1007/s13304-024-01979-0. Epub 2024 Sep 14.
PubMed 39277557
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Intestinal Fatty Acid Binding Protein in Predicting Gastrointestinal Involvement in Pediatric IgA Vasculitis
- ClinicalTrials.gov ID
- NCT07664228
- Acronym / sponsor ID
- IFABP-IgAV / IFABP-IgAV-2026
- Conditions
- IgA Vasculitis, Gastrointestinal Involvement
- Keywords
- IgA Vasculitis, Henoch-Schönlein Purpura, I-FABP, Intestinal Fatty Acid Binding Protein, Gastrointestinal Involvement, Children, Pediatric Rheumatology
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Bursa City HospitalOther government
- Study start
- 15 May 2026 (actual)
- Primary completion
- 15 Feb 2027 (estimated)
- Study completion
- 15 May 2027 (estimated)
- First posted
- 24 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 prospective observational study aims to evaluate plasma intestinal fatty acid-binding protein (I-FABP) levels in children with IgA vasculitis and investigate their association with gastrointestinal involvement. Blood samples will be collected at diagnosis and during follow-up 2-4 weeks later. The study will assess the potential value of plasma I-FABP as a biomarker for gastrointestinal involvement in pediatric IgA vasculitis.
Detailed description
This prospective observational cohort study aims to evaluate the association between plasma intestinal fatty acid-binding protein (I-FABP) levels and gastrointestinal involvement in children with IgA vasculitis (Henoch-Schönlein purpura).
Children aged 2-18 years who fulfill the EULAR/PRINTO/PRES classification criteria for IgA vasculitis will be enrolled. Clinical, laboratory, and demographic data will be collected at diagnosis (baseline). Participants will be followed prospectively, and a second assessment will be performed during the routine follow-up visit at approximately 2-4 weeks after diagnosis.
Blood samples will be obtained at baseline and during follow-up. Plasma will be separated and stored for subsequent measurement of I-FABP levels. The primary objective is to determine whether plasma I-FABP levels are associated with the presence of gastrointestinal involvement in pediatric IgA vasculitis.
Participants will be classified according to the presence or absence of gastrointestinal involvement. Clinical manifestations, laboratory findings, and plasma I-FABP levels will be compared between groups. The study does not involve administration of investigational drugs, devices, or therapeutic interventions. All procedures are performed as part of routine clinical follow-up with additional blood sampling for biomarker analysis.
The findings may help identify noninvasive biomarkers for the early detection and assessment of gastrointestinal involvement in children with IgA vasculitis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pediatric IgA Vasculitis Patients With Gastrointestinal Involvement | – | Diagnostic Test: Plasma I-FABP MeasurementChildren with IgA vasculitis and gastrointestinal involvement. |
| Pediatric IgA Vasculitis Patients Without Gastrointestinal Involvement | – | Diagnostic Test: Plasma I-FABP MeasurementChildren with IgA vasculitis without gastrointestinal involvement. |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children aged 2-18 years with newly diagnosed IgA vasculitis who are followed at a tertiary pediatric rheumatology center. Participants will be prospectively evaluated for gastrointestinal involvement and plasma I-FABP levels at diagnosis and during routine follow-up approximately 2-4 weeks later.
Key inclusion criteria (5 listed)
- Diagnosis of IgA vasculitis (Henoch-Schönlein purpura) according to EULAR/PRINTO/PRES classification criteria.
- Age between 2 and 18 years.
- Availability for blood sample collection at diagnosis (baseline visit).
- Ability to attend a routine follow-up visit approximately 2-4 weeks after diagnosis.
- Parent or legal guardian able and willing to provide written informed consent.
Key exclusion criteria (3 listed)
- Refusal of informed consent by the parent/legal guardian.
- Inability to obtain a baseline blood sample.
- Inability to complete study follow-up procedures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plasma I-FABP MeasurementBlood samples are collected and plasma I-FABP levels are measured to evaluate gastrointestinal involvement in pediatric IgA vasculitis. | Diagnostic test | Pediatric IgA Vasculitis Patients With Gastrointestinal Involvement, Pediatric IgA Vasculitis Patients Without Gastrointestinal Involvement |
Primary outcome
Plasma I-FABP Levels
Time frame: At baseline (T0) and at follow-up 2-4 weeks after diagnosis
Assessment of plasma I-FABP levels and their association with gastrointestinal involvement in pediatric IgA vasculitis patients.
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 24 Jun 2026.
- Background: PubMed 26726140Kocsis D, Papp M, Tornai T, Tulassay Z, Herszenyi L, Toth M, Juhasz M. [Intestinal fatty acid binding protein: marker of enterocyte damage in acute and chronic gastroenterological diseases]. Orv Hetil. 2016 Jan 10;157(2):59-64. doi: 10.1556/650.2016.30336. Hungarian.
- Background: PubMed 26798632Cheng S, Yu J, Zhou M, Tu Y, Lu Q. Serologic Intestinal-Fatty Acid Binding Protein in Necrotizing Enterocolitis Diagnosis: A Meta-Analysis. Biomed Res Int. 2015;2015:156704. doi: 10.1155/2015/156704. Epub 2015 Dec 22.
- Background: PubMed 25807642Sarikaya M, Ergul B, Dogan Z, Filik L, Can M, Arslan L. Intestinal fatty acid binding protein (I-FABP) as a promising test for Crohn's disease: a preliminary study. Clin Lab. 2015;61(1-2):87-91. doi: 10.7754/clin.lab.2014.140518.
- Background: PubMed 39277557Tyagunov AE, Anurov MV, Titkova SM, Kurashinova LS, Loban KM, Tyagunov AA, Sazhin AV. Intestinal fatty acid-binding protein (I-FABP) as biomarker of ischemic damage in experimentally induced 12-h small bowel obstruction. Updates Surg. 2024 Nov;76(7):2693-2700. doi: 10.1007/s13304-024-01979-0. Epub 2024 Sep 14.
- Individual participant dataSharing planned: No. Individual participant data will not be shared in order to protect participant privacy and confidentiality.
Related trials for IgA Vasculitis
Not yet recruiting
MYTP01 for Immune-Mediated Diseases
IgA Nephropathy, Kidney Transplant Recipients
Active, not recruitingPhase 1/2
An Open-label Study of Povetacicept in Autoantibody-Associated Glomerular Diseases
Lupus Nephritis, Immunoglobulin A Nephropathy
Recruiting
To Assess the Efficacy and Safety of Utilizing Galactose-deficient IgA1 Biomarker Changes to Guide Pathogenic IgA-targeted Therapeutic Strategies
IgA Nephropathy (IgAN), Henoch Schönlein Purpura Nephritis
Not yet recruitingEarly Phase 1
A Clinical Study Evaluating the Safety and Efficacy of GT719 Universal Cell Injection in the Treatment of Immune-mediated Kidney Diseases
IgA Nephropathy (IgAN), Membranous Nephropathy
RecruitingPhase 2
A Randomized Multicenter Study for Isolated Skin Vasculitis
Primary Cutaneous Vasculitis, Cutaneous Polyarteritis Nodosa
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.
Tuba Kurt, MD, Associate Professor principal investigator
Health Sciences University Bursa City Hospital, Department of Pediatric Rheumatology
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 IgA Vasculitis and Gastrointestinal Involvement, run by Bursa City Hospital at 1 site in Turkey (Türkiye).
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 3 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: looking for participants now, as of the sponsor's last update on 24 Jun 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 Turkey (Türkiye). 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 Nur Şeyma Zengin, MD (+90 5064767328, nszengin37@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma I-FABP Levels (time frame: At baseline (T0) and at follow-up 2-4 weeks after diagnosis). 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 NCT07664228, which also lists 4 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 24 Jun 2026.