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NCT07888439
Oral Immunotherapy for Children With Egg Allergy
Conditions: Egg Allergy, Egg Hypersensitivity, Food Allergy in Children, Food Allergies
Sex: All
Ages: 6 Months – 18 Months
Healthy volunteers: No
Phase: NA
Enrollment: 76
Sponsor: Laura Ozer Kettner
Location: The Danish Center of Pediatric Pulmonology and Allergology, Department of Pediatrics and Adolescent Medicine, Aarhus University Hospital Aarhus
Summary
This clinical trial aims to investigate if oral immunotherapy can help children with egg allergy tolerate eggs.
Children aged 6-18 months can take part in the trial.
Main question: What percentage of children can tolerate eggs after oral immunotherapy, compared with children who avoid eggs?
Children are assigned to these two groups by chance.
Children receiving oral immunotherapy will:
* Take a small, increasing amount of raw egg daily for 1-1.5 years
* Attend clinic or online visits each time the dose is increased
* Record missed doses
All children will:
* Provide blood samples to measure allergy-related markers
* Undergo an oral food challenge with raw egg after 1-1.5 years to assess how much they can tolerate
* Report allergic reactions (parent-reported)
* Complete questionnaires (parent-reported)
* Participate in an end-of-study telephone interview with an allergy nurse (parent-reported)
Eligibility Criteria
Inclusion Criteria:
* Aged 6 to 18 months
* Egg allergy confirmed at an oral food challenge
* Reaction threshold below 300 mg of raw egg protein at the oral food challenge
* Specific IgE to eggs \> 0.35 kU/L
* High risk of persistent allergy to eggs (based on defined criteria)
* Family motivated for oral immunotherapy following shared decision-making using a decision aid
Exclusion Criteria:
* Uncontrolled asthma, eczema, rhinoconjunctivitis, urticaria, or eosinophilic esophagitis
* Treatment with biologic or immunosuppressive medication
* Non-Danish-speaking families
* Anticipated non-adherent families
Source: ClinicalTrials.gov (NCT07888439). StuddyBuddy aggregates publicly available trial information.