Atopic Dermatitis (AD)DIANANCT07316465
Birth Cohort: Development of IgE Autoantibodies in Newborns With (High Risk of) Atopic Dermatitis
A study testing Development of atopic dermatitis with/without IgE autoantibodies in people with Atopic Dermatitis (AD) and Autoantibody, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial 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". Read more about this study
- Who is it for?
- Ages 1 hour to 24 monthsHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis (AD), Autoantibody, Auto-Immunity
- What is being tested?
- Development of atopic dermatitis with/without IgE autoantibodies
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Oct 2023to 31 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 hour to 24 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Newborns who are planned to be born at the maternity ward of UZ Brussel with the following criteria:
- 400 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)
- 100 newborns with low-risk for AD-development (no parents or siblings with history of atopic dermatitis AND/OR asthma AND/OR allergic rhinitis)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Carine Vleminckx contact
Belgium1 site, 1 recruiting
- Recruiting
Universitair Ziekenhuis (UZ) Brussel, Vrije Universiteit Brussel (VUB)
Jette, Brussels Capital, 1090
Inge Kortekaas Krohn, PhD, +32 (0)2 477 4244, inge.kortekaas@vub.be
Carine Vleminckx, carine.vleminckx@uzbrussel.be
About this study
Official title: Development of IgE Autoantibodies in Newborns With Atopic Dermatitis (DIANA) Birth Cohort
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.
Read more
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.
Read the detailed description
IgE autoantibodies against self-peptides in the skin have been identified in a subgroup of patients AD. These autoantibodies are present in subjects with comorbid allergic diseases in particular and are usually absent in healthy individuals, suggesting a link between IgE autoreactivity and allergic disease burden (Kortekaas Krohn I, et al. Allergy 2023). A prevalence of 15% of IgE autoantibodies was reported in infants younger than one year with AD, proving the development of IgE autoantibodies already early in life (Mothes N, et al. J Allergy Clin Immunol 2005).
The Development of IgE Autoantibodies in Newborns with (a high-risk of) Atopic dermatitis (DIANA) study is a large birth cohort, including a well-characterized and demographically diverse population with extensive early-life data of the infants and their parents. The DIANA birth cohort has an interdisciplinary design with a follow-up until the age of two years, enabling detailed monitoring of AD and other conditions.
In the present study, it is hypothesized that hereditary factors, lifestyle, and the environment can influence the development of self-reactive antibodies. To assess hereditary factors, a one-time blood sample will be taken from the biological mother and father, focusing solely on self-reactive antibodies and inflammatory substances. In addition, non-invasive and painless skin barrier measurements will be performed to study the skin barrier function. Environmental factors are investigated through questionnaires and swabs are being taken from the skin or stool to study the composition of the microbes.
The primary objective is:
To determine the presence of self-reactive antibodies at birth or early development.
Secondary objectives are:
- to investigate whether the presence of self-reactive antibodies is correlated with the development of atopic eczema during the first two years of life
- to study whether heredity can influence the development of self-reactive antibodies
- to examine whether environmental factors can influence the development of self-reactive antibodies
Eligible parents who plan to give birth at the University Hospital (UZ) Brussel will be offered the opportunity to participate in the study. If they are interested, the prenatal baseline visit (visit 1) is scheduled. A total of five visits will be scheduled over two years. After birth, umbilical cord blood will be collected and the second visit will take place within 72 hours. Follow-up visits will be scheduled at 6 months of age (visit 3), 12 months (visit 4), and 24 months (visit 4).
- Conditions
- Atopic Dermatitis (AD), Autoantibody, Auto-Immunity, Microbiome, Human, Allergic Disease, IgE-Mediated Hypersensitivity
- Being tested
- Development of atopic dermatitis with/without IgE autoantibodies
- Keywords
- Birth cohort, Autoantibodies, IgE, Atopic dermatitis, DIANA
- Medical subject headings
- Dermatitis, Atopic, Hypersensitivity, Immediate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Development of atopic dermatitis with/without IgE autoantibodies |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From enrollment to study visit 2 after birth.
Secondary outcomes (4)
Correlation between the presence of IgE autoantibodies and the development of atopic dermatitis
The presence of IgE autoantibodies will be measured after birth, at 6, 12 and 24 months of age. The skin will be examined by a dermatologist (resident) after birth, 6, 12 and 24 months for dryness and/or the presence of atopic dermatitis (according to the Hanifin and Rajka criteria). The subjects will be subdivided based on the presence of IgE autoantibodies and correlated with the skin conditions.
Measured: From visit 2 (after birth) to visit 5 at 24 months of age.
Correlation of IgE autoantibodies with IgE levels in serum
We will sub-divide the participants based on the presence of IgE autoantibodies (positive or negative) and analyse the levels of IgE in serum (kU/L).
Measured: From visit 2 after birth to visit 5 at 24 months of age.
Investigation of the hereditary factor in case IgE autoantibodies present
Serum is collected from both of the biological parents (if available/possible) to measure the presence of IgE autoantibodies for evaluatation of evaluation of the hereditary factor.
- In case IgE autoantibodies are present in the infant after birth, we will evaluate if the mother is positive too (spill-over from the mother?).
- If they develop autoantibodies during the two-year follow-up period, we will analyse if (one or both) the parents are positive as well.
Measured: From enrollment to visit 5 at 24 months.
Characterization of leukocytes in infants
- Characterization of leukocytes in infants and correlate with the presence of IgE autoantibodies (positive, negative)
- Characterization of leukocytes in infants and correlate with the development of AD (present yes/no)
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2026
- Study start1 Oct 2023
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Atopic Dermatitis (AD)Studies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Collaborators
- Vrije Universiteit Brussel
- Responsible party
- Principal investigator, Inge Kortekaas, Universitair Ziekenhuis Brussel
- Investigators
- Jan Gutermuth, MD PhD, Study director, Universitair Ziekenhuis (UZ) Brussel, Vrije Universiteit Brussel (VUB)Inge Kortekaas Krohn, PhD, Principal investigator, Universitair Ziekenhuis (UZ) Brussel, Vrije Universiteit Brussel (VUB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07316465
- Sponsor's protocol ID
- EC-2023-074
- Other IDs
- 18E2K24N, G056322N
- Acronym
- DIANA
- Status last verified
- Nov 2025
- First submitted
- 21 Nov 2025
- Last updated
- 5 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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).
Publications
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.
PubMed 37555488Kolkhir 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.
PubMed 38429523Kortekaas 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.
PubMed 37489049Belasri H, De Leye H, Saerens J, Vandermeersch L, Badloe FM, Vandeneynde A, Lenie S, De Vriese S, Gies I, Cools F, Gucciardo L, Kortekaas Krohn I, Gutermuth J. Development of IgE autoantibodies in newborns with atopic dermatitis (DIANA): protocol of a prospective, non-interventional, observational birth cohort. BMJ Open. 2026 May 29;16(5):e114509. doi: 10.1136/bmjopen-2025-114509.
PubMed 42215271
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of IgE Autoantibodies in Newborns With Atopic Dermatitis (DIANA) Birth Cohort
- ClinicalTrials.gov ID
- NCT07316465
- Acronym / sponsor ID
- DIANA / EC-2023-074
- Conditions
- Atopic Dermatitis (AD), Autoantibody, Auto-Immunity, Microbiome, Human, Allergic Disease, IgE-Mediated Hypersensitivity
- Keywords
- Birth cohort, Autoantibodies, IgE, Atopic dermatitis, DIANA
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Collaborators
- Vrije Universiteit Brussel
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 5 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
IgE autoantibodies against self-peptides in the skin have been identified in a subgroup of patients AD. These autoantibodies are present in subjects with comorbid allergic diseases in particular and are usually absent in healthy individuals, suggesting a link between IgE autoreactivity and allergic disease burden (Kortekaas Krohn I, et al. Allergy 2023). A prevalence of 15% of IgE autoantibodies was reported in infants younger than one year with AD, proving the development of IgE autoantibodies already early in life (Mothes N, et al. J Allergy Clin Immunol 2005).
The Development of IgE Autoantibodies in Newborns with (a high-risk of) Atopic dermatitis (DIANA) study is a large birth cohort, including a well-characterized and demographically diverse population with extensive early-life data of the infants and their parents. The DIANA birth cohort has an interdisciplinary design with a follow-up until the age of two years, enabling detailed monitoring of AD and other conditions.
In the present study, it is hypothesized that hereditary factors, lifestyle, and the environment can influence the development of self-reactive antibodies. To assess hereditary factors, a one-time blood sample will be taken from the biological mother and father, focusing solely on self-reactive antibodies and inflammatory substances. In addition, non-invasive and painless skin barrier measurements will be performed to study the skin barrier function. Environmental factors are investigated through questionnaires and swabs are being taken from the skin or stool to study the composition of the microbes.
The primary objective is:
To determine the presence of self-reactive antibodies at birth or early development.
Secondary objectives are:
- to investigate whether the presence of self-reactive antibodies is correlated with the development of atopic eczema during the first two years of life
- to study whether heredity can influence the development of self-reactive antibodies
- to examine whether environmental factors can influence the development of self-reactive antibodies
Eligible parents who plan to give birth at the University Hospital (UZ) Brussel will be offered the opportunity to participate in the study. If they are interested, the prenatal baseline visit (visit 1) is scheduled. A total of five visits will be scheduled over two years. After birth, umbilical cord blood will be collected and the second visit will take place within 72 hours. Follow-up visits will be scheduled at 6 months of age (visit 3), 12 months (visit 4), and 24 months (visit 4).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infants born at UZ Brussel | Other | Other: Development of atopic dermatitis with/without IgE autoantibodiesCord 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. |
Who may qualify
- Ages
- 1 hour to 24 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Newborns who are planned to be born at the maternity ward of UZ Brussel with the following criteria:
- 400 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)
- 100 newborns with low-risk for AD-development (no parents or siblings with history of atopic dermatitis AND/OR asthma AND/OR allergic rhinitis)
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Development of atopic dermatitis with/without IgE autoantibodiesNo 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. | Other | Infants born at UZ Brussel |
Primary outcome
Prevalence of IgE autoantibodies against skin epitopes in newborns
Time frame: From enrollment to study visit 2 after birth.
The prevalence (or first developmental stages) of IgE autoantibodies directed against keratinocyte-derived proteins in newborns (with high risk of atopic dermatitis).
4 secondary outcomes
Correlation between the presence of IgE autoantibodies and the development of atopic dermatitis
Time frame: From visit 2 (after birth) to visit 5 at 24 months of age.
Correlation of IgE autoantibodies with IgE levels in serum
Time frame: From visit 2 after birth to visit 5 at 24 months of age.
Investigation of the hereditary factor in case IgE autoantibodies present
Time frame: From enrollment to visit 5 at 24 months.
Characterization of leukocytes in infants
Time frame: Through study completion, an average of 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2026.
- Background: PubMed 37555488Charles 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.
- Background: PubMed 38429523Kolkhir 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.
- Background: PubMed 37489049Kortekaas 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.
- Derived from this study: PubMed 42215271Belasri H, De Leye H, Saerens J, Vandermeersch L, Badloe FM, Vandeneynde A, Lenie S, De Vriese S, Gies I, Cools F, Gucciardo L, Kortekaas Krohn I, Gutermuth J. Development of IgE autoantibodies in newborns with atopic dermatitis (DIANA): protocol of a prospective, non-interventional, observational birth cohort. BMJ Open. 2026 May 29;16(5):e114509. doi: 10.1136/bmjopen-2025-114509.
- Individual participant dataSharing planned: No. 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).
Related trials for Atopic Dermatitis (AD)
RecruitingPhase 3
Roflumilast Cream 0.3% for Moderate to Severe Atopic Dermatitis
Atopic Dermatitis, Atopic Dermatitis (AD)
RecruitingPhase 1
A Phase 1/1b Study to Evaluate Safety, Tolerability and Pharmacokinetics of ZL-1503 in Healthy Volunteers and Participants With Moderate to Severe Atopic Dermatitis
Atopic Dermatitis (AD)
Not yet recruitingPhase 1
A Study of NOR-101 in Healthy Adults and Adults With Moderate-to-Severe Atopic Dermatitis
Atopic Dermatitis (AD)
RecruitingPhase 2
PRA-216 Atopic Dermatitis Safety and Efficacy Study
Atopic Dermatitis (AD)
RecruitingPhase 2
Phase II Clinical Study to Evaluate the Efficacy and Safety of LT-002-158 Tablets in Adult Patients With Moderate-to-Severe Atopic Dermatitis
Atopic Dermatitis (AD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Carine Vleminckx contact
Jan Gutermuth, MD PhD study director
Universitair Ziekenhuis (UZ) Brussel, Vrije Universiteit Brussel (VUB)
Inge Kortekaas Krohn, PhD principal investigator
Universitair Ziekenhuis (UZ) Brussel, Vrije Universiteit Brussel (VUB)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Development of atopic dermatitis with/without IgE autoantibodies in people with Atopic Dermatitis (AD) and Autoantibody, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Inge Kortekaas Krohn, PhD (+32 (0)2 477 4244, inge.kortekaas@vub.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of IgE autoantibodies against skin epitopes in newborns (time frame: From enrollment to study visit 2 after birth.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07316465, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2026.