NCT07316465

Brief Summary

Previous research has shown that some patients with atopic eczema have specific self-reactive antibodies, known as IgE autoantibodies, that react to their own skin cells, referred to as "self-reactive antibodies" or "autoantibodies". It is not yet known when and how these self-reactive antibodies develop, so this is what we aim to investigate. This study aims to examine the presence of self-reactive antibodies at birth. In other words, the investigators want to study the earliest stage of developing antibodies that target the body's own skin cells. Additionally, factors that contribute to the development of these self-reactive antibodies will be explored as well as the correlation with the development of atopic eczema. The study will involve newborns who are at an increased risk of developing atopic eczema due to a family history of asthma, hay fever, or atopic eczema. There will also be a control group of newborns without these characteristics. The study's approach is to examine a portion of the umbilical cord blood, which is routinely collected after birth, to investigate self-reactive antibodies. The goal is to determine whether these self-reactive antibodies are linked to the development of atopic eczema in the first two years of life. For this purpose, follow-ups will be conducted at the ages of 6, 12, and 24 months. This study will contribute to an increased understanding of the prevalence of self-reactive antibodies and the factors influencing their development. Moreover, the study will determine whether these antibodies play a role in the prevention of and/or serve as predictive factors for the development of atopic eczema.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
56mo left

Started Oct 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress36%
Oct 2023Dec 2030

Study Start

First participant enrolled

October 1, 2023

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

November 21, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 5, 2026

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2029

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

January 5, 2026

Status Verified

November 1, 2025

Enrollment Period

6.3 years

First QC Date

November 21, 2025

Last Update Submit

December 18, 2025

Conditions

Atopic Dermatitis (AD)AutoantibodyAuto-ImmunityMicrobiome, HumanAllergic DiseaseIgE-Mediated HypersensitivityNewborn Infant

Keywords

Birth cohortAutoantibodiesIgEAtopic dermatitisDIANA

Outcome Measures

Primary Outcomes (1)

  • Prevalence of IgE autoantibodies against skin epitopes in newborns

    The prevalence (or first developmental stages) of IgE autoantibodies directed against keratinocyte-derived proteins in newborns (with high risk of atopic dermatitis).

    From enrollment to study visit 2 after birth.

Secondary Outcomes (4)

  • Correlation between the presence of IgE autoantibodies and the development of atopic dermatitis

    From visit 2 (after birth) to visit 5 at 24 months of age.

  • Correlation of IgE autoantibodies with IgE levels in serum

    From visit 2 after birth to visit 5 at 24 months of age.

  • Investigation of the hereditary factor in case IgE autoantibodies present

    From enrollment to visit 5 at 24 months.

  • Characterization of leukocytes in infants

    Through study completion, an average of 2 years

Other Outcomes (5)

  • Determination of serum inflammatory mediators

    From visit 2 after birth to visit 5 at 24 months of age.

  • Skin barrier function: Electrical impedance spectroscopy

    From after birth (visit 2) to visit 5 at 24 months

  • Skin barrier function: Natural moisturizing factor

    From 6 (visit 2) to 24 months of age (visit 5)

  • +2 more other outcomes

Study Arms (1)

Infants born at UZ Brussel

OTHER

Cord blood, blood drawl at 6, 12 and 24 months of age, electrical impedance spectroscopy, natural moisturizing factor, skin swab, stool swab, questionnaires, skin check (disease scores). These interventions will be the same for all participants.

Other: Development of atopic dermatitis with/without IgE autoantibodies

Interventions

Development of atopic dermatitis with/without IgE autoantibodiesOTHER

No studies have been performed on the presence of IgE autoantibodies at birth and whether this is related to AD development, prediction of the development of atopic diseases (biomarker) or clinical relevance in the pathophysiology. Causative environmental and hereditary factors still need to be unraveled. We assume that newborns with IgE autoantibodies are prone to develop atopic dermatitis and its comorbidities (food allergy, allergic asthma/ rhinitis) . In case IgE autoantibodies are identified in cord blood, this may originate from the mother and passes to the child due to maternal spillover , or it is produced by the fetus (prenatally) who produces IgE autoantibodies him/herself or by the infant in early life. This project aims to insights to the understanding of the first stages of IgE autoantibody development, its relation to AD and other allergic diseases as well as heredity and environmental factors. The endpoints study hold the potential to improve prevention and/or prognosis.

Infants born at UZ Brussel

Eligibility Criteria

Age1 Hour - 24 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Newborns who are planned to be born at the maternity ward of UZ Brussel with the following criteria:
  • newborns with high-risk for AD-development (at least 1 parent or sibling with physician diagnosed atopic dermatitis AND/OR asthma AND/OR allergic rhinitis)
  • newborns with low-risk for AD-development (no parents or siblings with history of atopic dermatitis AND/OR asthma AND/OR allergic rhinitis)

You may not qualify if:

  • Newborns not born at the maternity ward of UZ Brussel
  • Parents with a poor understanding of Dutch, French or English
  • Newborns who are admitted post-partum to the neonatal intensive care unit (gestational age \<34 weeks) or with medical complications
  • Newborns with severe genetic abnormalities/birth defects
  • Newborns whose parents will not be able to attend the study visits for a period of 2 years (location, working hours)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitair Ziekenhuis (UZ) Brussel, Vrije Universiteit Brussel (VUB)

Jette, Brussels Capital, 1090, Belgium

RECRUITING

Related Publications (3)

  • Charles N, Kortekaas-Krohn I, Kocaturk E, Scheffel J, Altrichter S, Steinert C, Xiang YK, Gutermuth J, Reber LL, Maurer M. Autoreactive IgE: Pathogenic role and therapeutic target in autoimmune diseases. Allergy. 2023 Dec;78(12):3118-3135. doi: 10.1111/all.15843. Epub 2023 Aug 9.

    PMID: 37555488BACKGROUND

  • Kolkhir P, Altrichter S, Badloe FMS, Belasri H, Charles N, De Vriese S, Gutermuth J, Huygen L, Kocaturk E, Kortekaas Krohn I, Munoz M, Monino-Romero S, Reber LL, Scheffel J, Steinert C, Xiang YK, Maurer M. The European Network for IgE-Mediated Autoimmunity and Autoallergy (ENIGMA) initiative. Nat Med. 2024 Apr;30(4):920-922. doi: 10.1038/s41591-024-02819-9. No abstract available.

    PMID: 38429523BACKGROUND

  • Kortekaas Krohn I, Badloe FMS, Herrmann N, Maintz L, De Vriese S, Ring J; CK-CARE Study Group; Bieber T, Gutermuth J. Immunoglobulin E autoantibodies in atopic dermatitis associate with Type-2 comorbidities and the atopic march. Allergy. 2023 Dec;78(12):3178-3192. doi: 10.1111/all.15822. Epub 2023 Jul 24.

    PMID: 37489049BACKGROUND

MeSH Terms

Conditions

Dermatitis, AtopicHypersensitivity, Immediate

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivityImmune System Diseases

Study Officials

  • Jan Gutermuth, MD PhD

    Universitair Ziekenhuis (UZ) Brussel, Vrije Universiteit Brussel (VUB)

    STUDY DIRECTOR

  • Inge Kortekaas Krohn, PhD

    Universitair Ziekenhuis (UZ) Brussel, Vrije Universiteit Brussel (VUB)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Inge Kortekaas Krohn, PhD

CONTACT

+32 (0)2 477 4244inge.kortekaas@vub.be

Carine Vleminckx

CONTACT

carine.vleminckx@uzbrussel.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

November 21, 2025

First Posted

January 5, 2026

Study Start

October 1, 2023

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

December 31, 2030

Last Updated

January 5, 2026

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

IDP sharing will be performed according to the institution's open access policy (for research) and in accordance with the EU/ Belgian law. The study protocol will be published in a scientific journal and publicly available (open access).

Locations

BE(1)