I-FABP as a Predictor of Gut Involvement in Pediatric IgA Vasculitis
Official title: The Role of Intestinal Fatty Acid Binding Protein in Predicting Gastrointestinal Involvement in Pediatric IgA Vasculitis
Run by Bursa City Hospital · NCT07664228 · Data updated 2026-11-12
This study checks if a blood marker called I-FABP can flag gut involvement in kids with IgA vasculitis by testing blood at diagnosis and again in 2–4 weeks.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 2 Years to 18 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Bursa City Hospital Government |
| Locations | 1 site (Bursa, Bursa) |
| Status | Recruiting |
| Started | May 15, 2026 |
| Main results expected | February 15, 2027 |
| Study ends | May 15, 2027 |
| Registry record updated | June 24, 2026 |
| Trial ID | NCT07664228 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children aged 2–18 years with IgA vasculitis who can provide blood samples at baseline and attend a 2–4 week follow-up.
✕Probably not a fit
Patients without gastrointestinal involvement or those unable to undergo follow-up may not benefit from the biomarker test.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is an observational cohort study in children with IgA vasculitis. Researchers will measure plasma I-FABP at diagnosis and at a 2–4 week follow-up to see if levels are linked to gastrointestinal involvement. Participants will be followed with routine clinical care, and no new treatments will be given as part of the study. Data on clinical features, labs, and demographics will be analyzed to determine the association between I-FABP and GI involvement. The aim is to explore I-FABP as a noninvasive biomarker for early detection and assessment of GI involvement in pediatric patients.
Why it matters
Potential benefit: If successful, the biomarker could help clinicians noninvasively identify GI involvement in pediatric IgA vasculitis.
How similar studies have gone: Biomarker studies with I-FABP have shown associations in related intestinal conditions, but this specific pediatric IgA vasculitis application is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Bursa City Hospital
Bursa, Bursa, Turkey (Türkiye) Recruiting
Study contacts
- Principal investigator: Tuba Kurt, MD, Associate Professor — Health Sciences University Bursa City Hospital, Department of Pediatric Rheumatology
- Study coordinator: Nur Şeyma Zengin, MD
- Email: nszengin37@hotmail.com
- Phone: +90 5064767328
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.