I-FABP as a Predictor of Gastrointestinal Involvement in Pediatric IgA Vasculitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Plasma I-FABP Measurement.
- Who it may be relevant to
- Registry conditions: IgA Vasculitis, Gastrointestinal Involvement. Basic parameters: 2 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Role of Intestinal Fatty Acid Binding Protein in Predicting Gastrointestinal Involvement in Pediatric IgA Vasculitis
Overview
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.
Detailed description
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.
Interventions
- Diagnostic test Plasma I-FABP Measurement
Blood samples are collected and plasma I-FABP levels are measured to evaluate gastrointestinal involvement in pediatric IgA vasculitis.
Primary outcome measures
- Plasma I-FABP Levels [Time frame: At baseline (T0) and at follow-up 2-4 weeks after diagnosis]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Turkey (Türkiye) · 1 center
- Bursa City Hospital — Bursa
Publications
- 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
Identifiers
NCT: NCT07664228 · IFABP-IgAV-2026