Allergy in ChildrenNCT04331522
Allergen Provocations- HCA Children's Hospital
An observational study of Allergy in Children, run by Josefine Gradman at 1 site in Denmark.
Trial summary
A prospective study of all allergen provocations performed in children at the Hans Christian Andersen Children's Hospital. Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Allergy in Children
- What is being tested?
- Oral provocation test
- Type of treatment
- Pill or oral medicine
- How many people
- 8,000 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Oct 2018to Oct 2039
- How long will I take part?
- 17 Years
- Phase
- Observational
- 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 0 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children referred to the department of pediatrics for investigation of allergy to foods or antibiotics
Who may be able to join
- clinical suspicion of allergy to foods or antibiotics informed concent -
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Susanne Halken, DMSc contact
Denmark1 site, 1 recruiting
- Recruiting
Hans Christian Andersen Children's Hospital
Odense, Odense C, 5000
Josefine Gradman, 004529241375, j.gradman@dadlnet.dk
About this study
Official title: Allergen Provocations at Hans Christian Andersen Children's Hospital
A prospective study of all allergen provocations performed in children at the Hans Christian Andersen Children's Hospital.
Read the detailed description
The purpose of the study is to investigate the impact of co-morbidities, history, and allergen tests on the outcome of allergen provocation tests.
Subjects are children aged 0-18 years old investigated for allergy to foods or antibiotics. Data entered in the database are demographics, co-morbidities, symptoms, SPT, specific IgE and details of the allergen provocations.
- Conditions
- Allergy in Children
- Being tested
- Oral provocation test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral provocation testDiagnostic test
Titrated provocation with allergen
| Study group | Role | What they receive |
|---|---|---|
| Antibiotics | Children aged 0-18 years investigated for allergy to antibiotics Receives: Diagnostic Test: Oral provocation test | |
| Milk | Children aged 0-18 years investigated for allergy to milk Receives: Diagnostic Test: Oral provocation test | |
| Egg | Children aged 0-18 years investigated for allergy to egg Receives: Diagnostic Test: Oral provocation test | |
| Peanut | Children aged 0-18 years investigated for allergy to peanut Receives: Diagnostic Test: Oral provocation test | |
| Hazelnut | Children aged 0-18 years investigated for allergy to hazelnut Receives: Diagnostic Test: Oral provocation test | |
| Sesame | Children aged 0-18 years investigated for allergy to sesame Receives: Diagnostic Test: Oral provocation test | |
| Wheat | Children aged 0-18 years investigated for allergy to wheat Receives: Diagnostic Test: Oral provocation test | |
| walnut | Children aged 0-18 years investigated for allergy to walnut Receives: Diagnostic Test: Oral provocation test | |
| cashew | Children aged 0-18 years investigated for allergy to cashew Receives: Diagnostic Test: Oral provocation test | |
| Pistachio | Children aged 0-18 years investigated for allergy to pistachio Receives: Diagnostic Test: Oral provocation test | |
| Almond | Children aged 0-18 years investigated for allergy to almond Receives: Diagnostic Test: Oral provocation test | |
| Soy | Children aged 0-18 years investigated for allergy to soy Receives: Diagnostic Test: Oral provocation test | |
| Fish | Children aged 0-18 years investigated for allergy to fish Receives: Diagnostic Test: Oral provocation test | |
| Shellfish | Children aged 0-18 years investigated for allergy to shellfish Receives: Diagnostic Test: Oral provocation test | |
| Poppy seed | Children aged 0-18 years investigated for allergy to poppy seed Receives: Diagnostic Test: Oral provocation test |
What is being measured
The primary outcome is the main question the study is designed to answer.
The association of allergy tests with the result of allergen provocation
The value of specific IgE and SPT to predict the outcome of a allergen provocation
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2020
- Study start1 Oct 2018
- Primary completionOct 2038 (estimated)
- Study completionOct 2039 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Allergy in ChildrenStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8,000 participants (estimated)
- Target duration
- 17 Years
Sponsor and investigators
- Lead sponsor
- Josefine Gradman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Josefine Gradman, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04331522
- Sponsor's protocol ID
- HCA-AP
- Status last verified
- Jul 2025
- First submitted
- 31 Mar 2020
- Last updated
- 10 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gradman J, Petersen BT, Halken S. Oral food challenge with raw egg: Sixty-minute- compared with 30-minute dosing interval. Clin Exp Allergy. 2022 Sep;52(9):1114-1117. doi: 10.1111/cea.14187. Epub 2022 Jul 4. No abstract available.
PubMed 35719001Petersen BT, Gradman J. Prospective study of 5-day challenge with penicillins in children. BMJ Paediatr Open. 2020 Aug 4;4(1):e000734. doi: 10.1136/bmjpo-2020-000734. eCollection 2020.
PubMed 32818157
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allergen Provocations at Hans Christian Andersen Children's Hospital
- ClinicalTrials.gov ID
- NCT04331522
- Acronym / sponsor ID
- HCA-AP
- Conditions
- Allergy in Children
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 8,000 participants (estimated)
- Lead sponsor
- Josefine GradmanUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- Oct 2038 (estimated)
- Study completion
- Oct 2039 (estimated)
- First posted
- 2 Apr 2020 (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.
A prospective study of all allergen provocations performed in children at the Hans Christian Andersen Children's Hospital.
Detailed description
The purpose of the study is to investigate the impact of co-morbidities, history, and allergen tests on the outcome of allergen provocation tests.
Subjects are children aged 0-18 years old investigated for allergy to foods or antibiotics. Data entered in the database are demographics, co-morbidities, symptoms, SPT, specific IgE and details of the allergen provocations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 17 Years
- Number of arms
- 15
| Arm | Type | Receives |
|---|---|---|
| Antibiotics | – | Diagnostic Test: Oral provocation testChildren aged 0-18 years investigated for allergy to antibiotics |
| Milk | – | Diagnostic Test: Oral provocation testChildren aged 0-18 years investigated for allergy to milk |
| Egg | – | Diagnostic Test: Oral provocation testChildren aged 0-18 years investigated for allergy to egg |
| Peanut | – | Diagnostic Test: Oral provocation testChildren aged 0-18 years investigated for allergy to peanut |
| Hazelnut | – | Diagnostic Test: Oral provocation testChildren aged 0-18 years investigated for allergy to hazelnut |
| Sesame | – | Diagnostic Test: Oral provocation testChildren aged 0-18 years investigated for allergy to sesame |
| Wheat | – | Diagnostic Test: Oral provocation testChildren aged 0-18 years investigated for allergy to wheat |
| walnut | – | Diagnostic Test: Oral provocation testChildren aged 0-18 years investigated for allergy to walnut |
| cashew | – | Diagnostic Test: Oral provocation testChildren aged 0-18 years investigated for allergy to cashew |
| Pistachio | – | Diagnostic Test: Oral provocation testChildren aged 0-18 years investigated for allergy to pistachio |
| Almond | – | Diagnostic Test: Oral provocation testChildren aged 0-18 years investigated for allergy to almond |
| Soy | – | Diagnostic Test: Oral provocation testChildren aged 0-18 years investigated for allergy to soy |
| Fish | – | Diagnostic Test: Oral provocation testChildren aged 0-18 years investigated for allergy to fish |
| Shellfish | – | Diagnostic Test: Oral provocation testChildren aged 0-18 years investigated for allergy to shellfish |
| Poppy seed | – | Diagnostic Test: Oral provocation testChildren aged 0-18 years investigated for allergy to poppy seed |
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children referred to the department of pediatrics for investigation of allergy to foods or antibiotics
Key inclusion criteria (1 listed)
- clinical suspicion of allergy to foods or antibiotics informed concent -
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Oral provocation testTitrated provocation with allergen | Diagnostic test | Almond, Antibiotics, Egg, Fish, Hazelnut, Milk, Peanut, Pistachio, Poppy seed, Sesame, Shellfish, Soy, Wheat, cashew, walnut |
Primary outcome
The association of allergy tests with the result of allergen provocation
Time frame: 5 years
The value of specific IgE and SPT to predict the outcome of a allergen provocation
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 10 Jul 2025.
- Derived from this study: PubMed 35719001Gradman J, Petersen BT, Halken S. Oral food challenge with raw egg: Sixty-minute- compared with 30-minute dosing interval. Clin Exp Allergy. 2022 Sep;52(9):1114-1117. doi: 10.1111/cea.14187. Epub 2022 Jul 4. No abstract available.
- Derived from this study: PubMed 32818157Petersen BT, Gradman J. Prospective study of 5-day challenge with penicillins in children. BMJ Paediatr Open. 2020 Aug 4;4(1):e000734. doi: 10.1136/bmjpo-2020-000734. eCollection 2020.
- Individual participant dataSharing planned: No
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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.
Susanne Halken, DMSc contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allergy in Children, run by Josefine Gradman at 1 site in Denmark.
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 1 inclusion and 1 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 10 Jul 2025. 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 Denmark. 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 Josefine Gradman, phd (+4529241375, josefine.gradman@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The association of allergy tests with the result of allergen provocation (time frame: 5 years). 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 NCT04331522, which also lists 2 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 10 Jul 2025.