Autoreactive IgE: Pathogenic role and therapeutic target in autoimmune diseases.
Nicolas Charles, Inge Kortekaas-Krohn, Emek Kocaturk...
https://pubmed.ncbi.nlm.nih.gov/37555488Actively Recruiting
Phase Not Applicable
Age: 1Hour - 24Months
All Genders
Healthy Volunteers
ID07316465
Development of IgE Autoantibodies in Newborns With Atopic Dermatitis (DIANA) Birth Cohort
Led by Universitair Ziekenhuis Brussel · Updated on 2026-01-05
500
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
U
Universitair Ziekenhuis Brussel
Lead Sponsor
V
Vrije Universiteit Brussel
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying how specific self-reactive antibodies called IgE autoantibodies develop in newborns, especially those at high risk for atopic dermatitis (AD) due to family history of asthma, hay fever, or eczema. This study aims to understand when these antibodies appear, how hereditary, lifestyle, and environmental factors influence their development, and their connection to the onset of AD during the first two years of life. The study follows a group of newborns born at the University Hospital Brussels, including 400 at high risk and 100 at low risk for AD. Researchers will collect umbilical cord blood at birth and conduct blood draws at 6, 12, and 24 months. Skin barrier function will be evaluated using non-invasive tests, and samples such as skin and stool swabs will be taken to study microbes. Questionnaires will gather environmental and lifestyle information, and disease scores will be assessed at follow-up visits. Participants will have five visits over two years: a prenatal baseline visit, birth visit within 72 hours, and follow-ups at 6, 12, and 24 months. The main measurement is the presence of IgE autoantibodies at birth. Researchers will monitor the development of AD, measure IgE levels, study hereditary influences through parental blood samples, and characterize infant immune cells. This comprehensive monitoring aims to reveal factors affecting antibody development and their role in AD risk.
CONDITIONS
Brief Title
Birth Cohort: Development of IgE Autoantibodies in Newborns With (High Risk of) Atopic Dermatitis
Who Can Participate
Age: 1Hour - 24Months
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Newborns planned to be born at the maternity ward of UZ Brussel
- Newborns aged from birth up to 24 months
- 400 newborns with at least one parent or sibling diagnosed with atopic dermatitis, asthma, or allergic rhinitis (high-risk group)
- 100 newborns without any parents or siblings with atopic dermatitis, asthma, or allergic rhinitis (low-risk group)
You will not qualify if you...
- Newborns not born at the maternity ward of UZ Brussel
- Parents with poor understanding of Dutch, French, or English
- Newborns admitted post-partum to neonatal intensive care unit with gestational age less than 34 weeks or with medical complications
- Newborns with severe genetic abnormalities or birth defects
- Newborns whose parents cannot attend study visits for two years due to location or working hours
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 prenatal baseline visit (in-person)
Surveillance
Duration - From birth to 24 months of age
Participants are monitored for the presence of self-reactive antibodies and development of atopic dermatitis through blood samples, skin measurements, questionnaires, and swabs.
1 visit within 72 hours after birth and visits at 6, 12, and 24 months of age
Trial Site Locations
Total: 1 location
1
Universitair Ziekenhuis (UZ) Brussel, Vrije Universiteit Brussel (VUB)
Jette, Brussels Capital, Belgium, 1090
Actively Recruiting
Loading map...
Research Team
I
Inge Kortekaas Krohn, PhD
C
Carine Vleminckx
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
The European Network for IgE-Mediated Autoimmunity and Autoallergy (ENIGMA) initiative.
Pavel Kolkhir, Sabine Altrichter, Fariza Mishaal Saiema Badloe...
https://pubmed.ncbi.nlm.nih.gov/38429523Immunoglobulin E autoantibodies in atopic dermatitis associate with Type-2 comorbidities and the atopic march.
Inge Kortekaas Krohn, Fariza Mishaal Saiema Badloe, Nadine Herrmann...
https://pubmed.ncbi.nlm.nih.gov/37489049