The study of SubLingual immunotherapy for Egg ALlergy in children

JRCT ID: jRCTs031220341

Registered date:20/09/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Egg allergy
• Date of first enrollment: 16/11/2022
• Target sample size: 36
• Study type: Interventional

Intervention(s)

After the observation at week 0, the parent or guardian freeze the assigned (hand-delivered by the attending physician) test or control powder, and dissolve it in 0.8 mL of water upon use and have the study subject (child) hold the solution containing the test or control powder under the tongue for 2 minutes and then vomit it up.
Observation period: 32 weeks (+/-1 week)

Outcome(s)

• Primary Outcome: Slope of change in hen egg white-specific IgE antibody titer up to week 32

Secondary Outcome

The following items up to week 32
(1) Change in the threshold for the intake of heated whole hen egg
(2) Proportion of subjects who achieved a cumulative intake of 4 g of heated whole hen egg
(3) Slope of change in serum immunoglobulin levels (excluding hen egg white-specific IgE antibody titer)

Key inclusion & exclusion criteria

• Age minimum: >= 4age old
• Age maximum: < 16age old
• Gender: Both

Include criteria

<Inclusion Criteria for provisional registration>
1) Patients with history of allegy to hen egg or foods containing hen egg
2) Patients who are aged 4 years old or elder and younger than 16 years old
3) Patients with egg white-specific IgE antibody titer of 0.70 uA/mL or higher within 12 months before giving their consent
4) Patients who are able to completely eliminate hen eggs and hen egg-containing foods during the study period (if they consume trace amounts of hen eggs, they can be included in the study after at least one month of complete elimination)
5) Patients whose legal representative give written consent to participate in the study

<Inclusion criteria for actual registration>
1) Patients with allegic reaction of Sampson's Grade 2 or higher to heated hen egg of 2 g or less at double-blinded heated hen egg challenge test

Exclude criteria

1) Patients who are currently receiving or will be initiating immunotherapy (whether oral, transdermal, sublingual, or subcutaneous) during the study period
2) Patients with a history of severe anaphylaxis (e.g., with respiratory failure, requiring management in intensive care unit, etc.) after ingestion of hen eggs, or patients who exibited the similar symptoms at double-blinded heated hen egg challenge test
3) Patients who present allergic symptoms to pumpkins
4) Patients who have difficulty in holding the antigen solution under the tongue for 2 minutes
5) Patients who do not agree to continue a hen egg elimination diet throughout the observation period
6) Patients who were able to consume 2 g of heated chicken egg without allergic symptoms at double-blinded heated hen egg challenge test
7) Patients who have received systemic steroid medication within one month before giving their consent
8) Patients with other conditions who are deemed ineligible by the attending physician.

Related Information

• Primary Sponsor: Katsunuma Toshio
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development