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

NCT07664228 | Recruiting

• 1 other identifier: IFABP-IgAV-2026
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

IgA Vasculitis; Gastrointestinal Involvement

Keywords

IgA Vasculitis; Henoch-Schönlein Purpura; I-FABP; Intestinal Fatty Acid Binding Protein; Gastrointestinal Involvement; Children; Pediatric Rheumatology

Outcome Measures

Primary Outcomes (1)

• Plasma I-FABP Levels

  Assessment of plasma I-FABP levels and their association with gastrointestinal involvement in pediatric IgA vasculitis patients.

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

Study Arms (2)

Pediatric IgA Vasculitis Patients With Gastrointestinal Involvement

Children with IgA vasculitis and gastrointestinal involvement.

Diagnostic Test: Plasma I-FABP Measurement

Pediatric IgA Vasculitis Patients Without Gastrointestinal Involvement

Children with IgA vasculitis without gastrointestinal involvement.

Diagnostic Test: Plasma I-FABP Measurement

Interventions

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.

Pediatric IgA Vasculitis Patients With Gastrointestinal Involvement; Pediatric IgA Vasculitis Patients Without Gastrointestinal Involvement

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children aged 2-18 years with newly diagnosed IgA vasculitis who are followed at a tertiary pediatric rheumatology center. Participants will be prospectively evaluated for gastrointestinal involvement and plasma I-FABP levels at diagnosis and during routine follow-up approximately 2-4 weeks later.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Bursa City Hospital: lead

Study Sites (1)

Bursa City Hospital

Bursa, Bursa, 16250, Turkey (Türkiye)

RECRUITING

Related Publications (4)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

EDTA plasma samples collected from pediatric IgA vasculitis patients will be stored at -80°C for measurement of intestinal fatty acid-binding protein (I-FABP). No DNA will be extracted or retained.

MeSH Terms

Conditions

IgA Vasculitis

Condition Hierarchy (Ancestors)

Vasculitis; Vascular Diseases; Cardiovascular Diseases; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemostatic Disorders; Hemorrhagic Disorders; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Immune Complex Diseases; Hypersensitivity; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Study Officials

• Tuba Kurt, MD, Associate Professor

  Health Sciences University Bursa City Hospital, Department of Pediatric Rheumatology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nur Şeyma Zengin, MD

CONTACT

+90 5064767328; nszengin37@hotmail.com

Tuba Kurt, MD, Associate Professor

CONTACT

+90 553 064 1000; drtubakurt@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Rheumatology Fellow

Study Record Dates

• First Submitted: June 17, 2026
• First Posted: June 24, 2026
• Study Start: May 15, 2026
• Primary Completion (Estimated): February 15, 2027
• Study Completion (Estimated): May 15, 2027
• Last Updated: June 24, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)