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Oral Immunotherapy With Egg in Infants

Oral Immunotherapy With Egg

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07540091
Acronym
OIT egg
Enrollment
40
Registered
2026-04-20
Start date
2026-04-20
Completion date
2036-12-01
Last updated
2026-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Food Allergy in Infants

Keywords

oral immunotherapy, OIT, egg

Brief 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. 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

Interventions

OTHERlow-dose OIT egg

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

Sponsors

Josefine Gradman
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
12 Months to 36 Months
Healthy volunteers
No

Inclusion criteria

* positive specific IgE to egg * positive oral provocation for egg * low threshold

Exclusion criteria

* uncontrolled astham treatment with biologics or immunsupressive drugs treatment with antihistamines

Design outcomes

Primary

MeasureTime frameDescription
Percentage of children who develops tolerance to egg per yearIf 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 yearsOnce a year the children will undergo an oral food provocation with egg to investigate if they have becomed tolerant to egg

Secondary

MeasureTime frameDescription
specific IgEbaseline and through study completion, an average of 1 yearMeasurement of specific IgE to egg in the blood

Contacts

CONTACTJosefine Gradman, MD, PhD
josefine.gradman@rsyd.dk+4529241375
STUDY_CHAIRJane Clemmensen, Professor

H.C.Andersens Børne- og Ungehospital, Odense University Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 21, 2026