RecruitingNot Applicable

I-FABP as a Predictor of Gastrointestinal Involvement in Pediatric IgA Vasculitis

Turkey (Türkiye)100 participantsStarted 2026-05-15

Plain-language 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.

Who can participate

Age range

2 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Plasma I-FABP Levels

Timeframe: At baseline (T0) and at follow-up 2-4 weeks after diagnosis

Trial details

NCT IDNCT07664228

SponsorBursa City Hospital

Sponsor typeOTHER_GOV

Study typeOBSERVATIONAL

Primary completion2027-02-15

Contact for this trial

Nur Şeyma Zengin, MD

+90 5064767328 nszengin37@hotmail.com

View on ClinicalTrials.gov More IgA Vasculitis trials