I-FABP as a Predictor of Gastrointestinal Involvement in Pediatric IgA Vasculitis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2-18
SponsorBursa City Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Refusal of informed consent by the parent/legal guardian.
Inability to obtain a baseline blood sample.
Inability to complete study follow-up procedures.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Plasma I-FABP Measurement
Diagnostic testBlood samples are collected and plasma I-FABP levels are measured to evaluate gastrointestinal involvement in pediatric IgA vasculitis.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Pediatric IgA Vasculitis Patients With Gastrointestinal Involvement1 intervention
Group B: Pediatric IgA Vasculitis Patients Without Gastrointestinal Involvement1 intervention
Trial outcomes
Primary outcomes
1
Plasma I-FABP Levels
Assessment of plasma I-FABP levels and their association with gastrointestinal involvement in pediatric IgA vasculitis patients.
Time frame
At baseline (T0) and at follow-up 2-4 weeks after diagnosisSponsors and contacts
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Source ClinicalTrials.gov