Gastrointestinal Involvement, IgA Vasculitis
Conditions
Keywords
IgA Vasculitis, Henoch-Schönlein Purpura, I-FABP, Intestinal Fatty Acid Binding Protein, Gastrointestinal Involvement, Children, Pediatric Rheumatology
Brief 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. 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.
Interventions
DIAGNOSTIC_TESTPlasma I-FABP Measurement
Blood samples are collected and plasma I-FABP levels are measured to evaluate gastrointestinal involvement in pediatric IgA vasculitis.
Sponsors
Bursa City Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
2 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* Refusal of informed consent by the parent/legal guardian. * Inability to obtain a baseline blood sample. * Inability to complete study follow-up procedures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma I-FABP Levels | 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. |
Countries
Turkey (Türkiye)
Contacts
CONTACTNur Şeyma Zengin, MD
CONTACTTuba Kurt, MD, Associate Professor
PRINCIPAL_INVESTIGATORTuba Kurt, MD, Associate Professor
Health Sciences University Bursa City Hospital, Department of Pediatric Rheumatology
Outcome results
None listed