Oral Immunotherapy With Egg in Infants (OIT egg)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Food Allergy in Infants
• Intervention / Treatment: Other: low-dose OIT egg

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 Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Josefine Gradman, MD, PhD; Phone Number: +4529241375; Email: josefine.gradman@rsyd.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
OIT egg; children with allergy to egg diagnosed after January 2026 will be offered OIT	Other: low-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
Non-OIT; Aged-matched children with allergy to egg diagnosed before January1, 2026, not offered OIT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
specific IgE	Measurement of specific IgE to egg in the blood	baseline and through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Josefine Gradman
• Investigators: Study Chair: Jane Clemmensen, Professor, H.C.Andersens Børne- og Ungehospital, Odense University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 20, 2026
• Primary Completion (Estimated): April 1, 2036
• Study Completion (Estimated): December 1, 2036

Study Registration Dates

• First Submitted: March 31, 2026
• First Submitted That Met QC Criteria: April 16, 2026
• First Posted (Actual): April 20, 2026

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: OIT; egg; oral immunotherapy
• Other Study ID Numbers: HCA-OIT_egg

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No