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A Study on the Treatment of Egg Allergy Using Enzymatically Hydrolyzed Egg White Powder

A Clinical trial of the Therapeutic effectiveness of Continuous intake of Enzymatically Hydrolyzed Egg White in the treatment of Hen's Egg Allergy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs041250128
Enrollment
100
Registered
2025-11-19
Start date
2026-01-05
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

hen's egg allergy food allergy, hen's egg allergy

Interventions

daily intake of an enzymatically hydrolyzed egg white (TDEW) powder

Sponsors

Kondo Yasuto
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Among egg allergy patients who are outpatients at Fujita Medical University Bantane Hospital or Fujita Medical University Hospital, those who meet the following criteria 1. Patients for whom, after receiving a thorough explanation and achieving adequate understanding, written informed consent was obtained of their own free will from both the legally authorized representative and the patient themselves (if the patient is capable of expressing their own wishes). 2. For pediatric patients aged 7 years or older who can comprehend language, verbal assent is sought using an assent form, and every effort is made to obtain their own agreement. 3. Patients who are at least 1 year old but under 15 years of age at the time of consent. 4. Patients diagnosed with egg allergy by a physician. 5.Patients who, in an oral food challenge test performed within the past two months, exhibited a symptom induction threshold between 0.3 g and 5.0 g of egg protein.

Exclusion criteria

Exclusion criteria: 1.Patients with a history of severe anaphylaxis triggered by the ingestion of 0.1g or less of egg white or whole egg within the past year. 2.Patients with severe complications or underlying medical conditions. 3.Patients who are taking oral or subcutaneous antihistamines, corticosteroids, JAK inhibitors, or other drugs with immunomodulatory effects 4.Patients deemed unsuitable by the principal investigator or sub-investigators for any other reason.

Design outcomes

Primary

MeasureTime frame
the tolerable dose of heated egg white in the oral food challenge at 24 weeks after the start of the trial

Secondary

MeasureTime frame
Differences between groups in the presence and frequency of induced symptoms during the study period (before the start of intake and after 24 weeks). Differences between groups in specific IgE antibody levels (before the start of intake and after 24 weeks). Differences between groups in specific IgG4 antibody levels (before the start of intake and after 24 weeks). Differences between groups in the reactivity of specific IgE as evaluated using the EXiLE method (IgE crosslinking-induced Luciferase Expression) (before the start of intake and after 24 weeks). Differences between groups in the burden on caregivers (before the start of intake and after 24 weeks). Differences between groups in the adherence of the patients themselves (after 24 weeks).

Contacts

Public ContactKaoru Okamoto

Fujita Health University Hospital

oluaq@fujita-hu.ac.jp+81-562-93-9251

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026