Food Allergy in InfantsOIT eggNCT07540091
Oral Immunotherapy With Egg in Infants
An observational study of Food Allergy in Infants, run by Josefine Gradman.
Trial summary
In children allergic to egg, oral immunotherapy (OIT) with egg may accelerate that the children grow out of the food allergy. Children than have a positive oral food provocation with egg with a low threshold, will be offered to start OIT. This means that the child have to ingest a small amount of egg every day. Read more about this study
- Who is it for?
- Ages 12 to 36 months
- Conditions the study is for
- Food Allergy in Infants
- What is being tested?
- low-dose OIT egg
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 20 Apr 2026to 1 Dec 2036
- How long will I take part?
- 5 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 12 to 36 months
- All sexes
- No healthy volunteers
- Child
Study population: Children that within 4 months have undergone a positive provocation with egg with a low threshold at Hans Christian Andersen Children's Hospital
Who may be able to join
- positive specific IgE to egg
- positive oral provocation for egg
- low threshold
Who cannot join
- uncontrolled astham treatment with biologics or immunsupressive drugs treatment with antihistamines
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Oral Immunotherapy With Egg
In children allergic to egg, oral immunotherapy (OIT) with egg may accelerate that the children grow out of the food allergy.
Children than have a positive oral food provocation with egg with a low threshold, will be offered to start OIT. This means that the child have to ingest a small amount of egg every day.
Once a year, the child will undergo a new oral food provocation to investigate if the child is still allergic to egg or not.
The age of the children at time of this acquired tolerance will be compared with a historical cohort of children with egg allergy.
Read the detailed description
The aim of the study is to investigate if OIT with egg white can accelerate tolerance to egg in infants with provocation-verified allergy to egg and with a low threshold.
The study is non-randomised. Children fulfilling the inclusion criteria will be offered OIT. The children will undergo an oral provocation once a year to detect development of tolerance to egg. Age at tolerance acquisition will be compared with a histical cohort of aged-matched children with allergy to egg and with a similar threshold at the diagnostic provocation
- Conditions
- Food Allergy in Infants
- Being tested
- low-dose OIT egg
- Keywords
- oral immunotherapy, OIT, egg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low-dose OIT eggOther
The children have to ingest a small specified amount of egg white every day. The amount will gradually increase, as the child becomes more and more tolerant to egg
| Study group | Role | What they receive |
|---|---|---|
| OIT egg | children with allergy to egg diagnosed after January 2026 will be offered OIT Receives: Other: low-dose OIT egg | |
| Non-OIT | Aged-matched children with allergy to egg diagnosed before January1, 2026, not offered OIT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of children who develops tolerance to egg per year
Once a year the children will undergo an oral food provocation with egg to investigate if they have becomed tolerant to egg
Measured: If the oral food provocation is negative (that is the child is still allergic to egg) the child will be re-provocated after 12 months. As long as the provocation is positive it will be repeated once a year for 5 years
Secondary outcomes (1)
specific IgE
Measurement of specific IgE to egg in the blood
Measured: baseline and through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start20 Apr 2026 (estimated)
- Primary completion1 Apr 2036 (estimated)
- Study completion1 Dec 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food Allergy in InfantsStudies 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
- 40 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Josefine Gradman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Josefine Gradman, Odense University Hospital
- Investigators
- Jane Clemmensen, Professor, Study chair, H.C.Andersens Børne- og Ungehospital, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07540091
- Sponsor's protocol ID
- HCA-OIT_egg
- Acronym
- OIT egg
- Status last verified
- Apr 2026
- First submitted
- 31 Mar 2026
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Immunotherapy With Egg
- ClinicalTrials.gov ID
- NCT07540091
- Acronym / sponsor ID
- OIT egg / HCA-OIT_egg
- Conditions
- Food Allergy in Infants
- Keywords
- oral immunotherapy, OIT, egg
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Josefine GradmanUniversity, hospital or other
- Study start
- 20 Apr 2026 (estimated)
- Primary completion
- 1 Apr 2036 (estimated)
- Study completion
- 1 Dec 2036 (estimated)
- First posted
- 20 Apr 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.
In children allergic to egg, oral immunotherapy (OIT) with egg may accelerate that the children grow out of the food allergy.
Children than have a positive oral food provocation with egg with a low threshold, will be offered to start OIT. This means that the child have to ingest a small amount of egg every day.
Once a year, the child will undergo a new oral food provocation to investigate if the child is still allergic to egg or not.
The age of the children at time of this acquired tolerance will be compared with a historical cohort of children with egg allergy.
Detailed description
The aim of the study is to investigate if OIT with egg white can accelerate tolerance to egg in infants with provocation-verified allergy to egg and with a low threshold.
The study is non-randomised. Children fulfilling the inclusion criteria will be offered OIT. The children will undergo an oral provocation once a year to detect development of tolerance to egg. Age at tolerance acquisition will be compared with a histical cohort of aged-matched children with allergy to egg and with a similar threshold at the diagnostic provocation
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OIT egg | – | Other: low-dose OIT eggchildren with allergy to egg diagnosed after January 2026 will be offered OIT |
| Non-OIT | – | –Aged-matched children with allergy to egg diagnosed before January1, 2026, not offered OIT |
Who may qualify
- Ages
- 12 to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children that within 4 months have undergone a positive provocation with egg with a low threshold at Hans Christian Andersen Children's Hospital
Key inclusion criteria (3 listed)
- positive specific IgE to egg
- positive oral provocation for egg
- low threshold
Key exclusion criteria (1 listed)
- uncontrolled astham treatment with biologics or immunsupressive drugs treatment with antihistamines
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 |
|---|---|---|
| low-dose OIT eggThe children have to ingest a small specified amount of egg white every day. The amount will gradually increase, as the child becomes more and more tolerant to egg | Other | OIT egg |
Primary outcome
Percentage of children who develops tolerance to egg per year
Time frame: If the oral food provocation is negative (that is the child is still allergic to egg) the child will be re-provocated after 12 months. As long as the provocation is positive it will be repeated once a year for 5 years
Once a year the children will undergo an oral food provocation with egg to investigate if they have becomed tolerant to egg
1 secondary outcome
specific IgE
Time frame: baseline and through study completion, an average of 1 year
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 20 Apr 2026.
- 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.
Jane Clemmensen, Professor study chair
H.C.Andersens Børne- og Ungehospital, Odense University Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Food Allergy in Infants, run by Josefine Gradman.
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 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: opening soon, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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, MD, 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?
Percentage of children who develops tolerance to egg per year (time frame: If the oral food provocation is negative (that is the child is still allergic to egg) the child will be re-provocated after 12 months. As long as the provocation is positive it will be repeated once a year for 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Apr 2026.