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Идёт набор NCT07664228

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

— Наблюдательное IgA Vasculitis Gastrointestinal Involvement

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Plasma I-FABP Measurement.
Кому может быть актуально
Состояния в реестре: IgA Vasculitis, Gastrointestinal Involvement. Базовые параметры: 2 лет — 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Диагностический тест Plasma I-FABP Measurement
    Blood samples are collected and plasma I-FABP levels are measured to evaluate gastrointestinal involvement in pediatric IgA vasculitis.

Первичные конечные точки

  • Plasma I-FABP Levels [Срок оценки: At baseline (T0) and at follow-up 2-4 weeks after diagnosis]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Turkey (Türkiye) · 1 центр
  • Bursa City Hospital — Bursa

Публикации

  • Kocsis D, Papp M, Tornai T, Tulassay Z, Herszenyi L, Toth M, Juhasz M. [Intestinal fatty acid binding protein: marker of enterocyte damage in acute and chronic gastroenterological diseases]. Orv Hetil. 2016 Jan 10;157(2):59-64. doi: 10.1556/650.2016.30336. Hungarian. PMID 26726140
  • Cheng S, Yu J, Zhou M, Tu Y, Lu Q. Serologic Intestinal-Fatty Acid Binding Protein in Necrotizing Enterocolitis Diagnosis: A Meta-Analysis. Biomed Res Int. 2015;2015:156704. doi: 10.1155/2015/156704. Epub 2015 Dec 22. PMID 26798632
  • Sarikaya M, Ergul B, Dogan Z, Filik L, Can M, Arslan L. Intestinal fatty acid binding protein (I-FABP) as a promising test for Crohn's disease: a preliminary study. Clin Lab. 2015;61(1-2):87-91. doi: 10.7754/clin.lab.2014.140518. PMID 25807642
  • Tyagunov AE, Anurov MV, Titkova SM, Kurashinova LS, Loban KM, Tyagunov AA, Sazhin AV. Intestinal fatty acid-binding protein (I-FABP) as biomarker of ischemic damage in experimentally induced 12-h small bowel obstruction. Updates Surg. 2024 Nov;76(7):2693-2700. doi: 10.1007/s13304-024-01979-0. Epub 2024 Sep 14. PMID 39277557

Идентификаторы

NCT: NCT07664228 · IFABP-IgAV-2026

Первоисточники (государственные реестры)

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