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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pediatric IgA Vasculitis Patients With Gastrointestinal Involvement | Children with IgA vasculitis and gastrointestinal involvement. |
| |
| Pediatric IgA Vasculitis Patients Without Gastrointestinal Involvement | Children with IgA vasculitis without gastrointestinal involvement. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plasma I-FABP Measurement | Diagnostic Test | Blood samples are collected and plasma I-FABP levels are measured to evaluate gastrointestinal involvement in pediatric IgA vasculitis. |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma I-FABP Levels | Assessment of plasma I-FABP levels and their association with gastrointestinal involvement in pediatric IgA vasculitis patients. | At baseline (T0) and at follow-up 2-4 weeks after diagnosis |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nur Şeyma Zengin, MD | Contact | +90 5064767328 | nszengin37@hotmail.com | |
| Tuba Kurt, MD, Associate Professor | Contact | +90 553 064 1000 | drtubakurt@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Tuba Kurt, MD, Associate Professor | Health Sciences University Bursa City Hospital, Department of Pediatric Rheumatology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bursa City Hospital | Recruiting | Bursa | Bursa | 16250 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26726140 | Background | 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. | |
| 26798632 | Background | Cheng 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. |
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Individual participant data will not be shared in order to protect participant privacy and confidentiality.
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| ID | Term |
|---|---|
| D011695 | IgA Vasculitis |
| ID | Term |
|---|---|
| D014657 | Vasculitis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D011693 | Purpura |
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EDTA plasma samples collected from pediatric IgA vasculitis patients will be stored at -80°C for measurement of intestinal fatty acid-binding protein (I-FABP). No DNA will be extracted or retained.
| 25807642 | Background | Sarikaya 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. |
| 39277557 | Background | Tyagunov 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. |
| D001778 |
| Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D020141 | Hemostatic Disorders |
| D006474 | Hemorrhagic Disorders |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007105 | Immune Complex Diseases |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |