Oral Immunotherapy With Egg in Infants

NCT07540091 | Not Yet Recruiting

• 1 other identifier: HCA-OIT_egg
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Food Allergy in Infants

Keywords

oral immunotherapy; OIT; egg

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• specific IgE

  baseline and through study completion, an average of 1 year

Study Arms (2)

OIT egg

children with allergy to egg diagnosed after January 2026 will be offered OIT

Other: low-dose OIT egg

Non-OIT

Aged-matched children with allergy to egg diagnosed before January1, 2026, not offered OIT

Interventions

low-dose OIT egg OTHER

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

OIT egg

Eligibility Criteria

• Age: 12 Months - 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Josefine Gradman: lead

Study Officials

• Jane Clemmensen, Professor

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

  STUDY CHAIR

Central Study Contacts

Josefine Gradman, MD, PhD

CONTACT

+4529241375; josefine.gradman@rsyd.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: March 31, 2026
• First Posted: April 20, 2026
• Study Start: April 20, 2026
• Primary Completion (Estimated): April 1, 2036
• Study Completion (Estimated): December 1, 2036
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share