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NCT Number: NCT07664228

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Plasma I-FABP Levels

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Nur Şeyma Zengin, MD

CONTACT

[email protected]

+90 5064767328

Tuba Kurt, MD, Associate Professor

CONTACT

[email protected]

+90 553 064 1000

Sponsors and collaborators

Lead sponsor

Bursa City Hospital

Other Gov

Registry information

Official study title

The Role of Intestinal Fatty Acid Binding Protein in Predicting Gastrointestinal Involvement in Pediatric IgA Vasculitis

Acronym: IFABP-IgAV

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 24, 2026
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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