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临床试验/NCT07664228
NCT07664228招募中不适用

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

Bursa City Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2026年5月15日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
1

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
2 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • Refusal of informed consent by the parent/legal guardian.
  • Inability to obtain a baseline blood sample.
  • Inability to complete study follow-up procedures.

研究者

发起方
Bursa City Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Dr. Nur Şeyma Zengin

Pediatric Rheumatology Fellow

Bursa City Hospital

研究点 (1)

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