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Evaluation of the Continuous Consumption of Allergen-Containing Foods

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	hen's egg allergy
Date of first enrollment	13/05/2026
Target sample size	50
Countries of recruitment
Study type	Interventional
Intervention(s)	Participants with egg allergy will be instructed to consume a processed food containing a microdose of egg allergen below the individually determined safe threshold, on a daily basis as much as possible.

Outcome(s)

Primary Outcome

Continuation rate of daily intake of the processed food containing a trace and constant amount of egg allergen at 12 and 24 weeks, determined from participant diaries and questionnaires, excluding days of illness.

Secondary Outcome

1.Safety evaluation during continuous intake: Presence and frequency of allergic reactions during the 24-week intake period and the need for medication at the time of reactions will be recorded in participant diaries. In addition, changes before and after 24 weeks of intake will be evaluated by blood tests, including Immunoblot and EXiLE responses, basophil activation test and lymphocyte stimulation test using egg white, antigen-specific T cell counts, and serum levels of AST, ALT, LDH, BUN, creatinine, CRP, total IgE, and specific IgE and IgG4 for ovomucoid and egg white. 2.Palatability evaluation: Assessment by questionnaire at the end of the study. 3.Quality of life (QOL) evaluation: Assessment by questionnaires at the beginning and end of the study.

Key inclusion & exclusion criteria

Age minimum	>= 3age old
Age maximum	< 21age old
Gender	Both
Include criteria	1. Patients who, upon participation in this study, provided written consent of their own free will after receiving full explanation and demonstrating sufficient understanding, either personally or through a proxy consenting on their behalf 2. Patients aged 3 years or older but under 21 years at the time of consent acquisition 3. Patients diagnosed with egg allergy, either by confirming a positive result in an oral egg challenge test or by exhibiting an immediate allergic reaction to egg consumption 4. Patients whose threshold for tolerable egg intake has been determined and falls within the specified range (greater than the amount of egg allergen contained in the processed food). 5. Patients for whom continued dietary guidance involving eggs and processed products containing eggs is difficult due to any of the following reasons: aversion to eggs, the environment for implementing dietary guidance (where the burden on caregivers for dietary guidance is high), or an inability to consume eggs or processed products containing eggs due to fear of allergic reactions.
Exclude criteria	1. Patients using immunosuppressive agents 2. Patients with severe complications such as severe heart disease, moderate to severe renal disease requiring oral medication or medical management, severe atopic dermatitis requiring systemic therapy including systemic steroids or biological agents, bronchial asthma, etc. 3. Other patients deemed inappropriate by the principal investigator or sub-investigator