Food allergy
Conditions
Interventions
1.Very small amount at the starting method (The experimental therapy group) -We set a cumulative tolerated dose of the hen'
s egg intake by oral challenge test on formal registration day. -Patients take in the experimental diet including the hen'
s egg (egg white and yolk) of 1/50 quantity of the cumulative tolerated dose the day after the initiation for 4 weeks. -Patients take in the experimental diet including the hen'
s egg of 1/10 quantity of the cumulative tolerated dose the day after from 4 to 8 weeks. -Patients take in the experimental diet including the hen'
s egg of half quantity of the cumulative tolerated dose the day after from 8 to 12 weeks. -Patients take in the experimental diet including the hen'
s egg of a cumulative tolerated dose the day after from 12 to 48 weeks.
2.Fixed-quantity maintenance method (Standard therapy group) -We set a cumulative tolerated dose of the hen'
s egg of a cumulative tolerated dose every day until 48 weeks later.
Sponsors
National Center for Child Health and Development
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria for temporary registration: (1)Patients diagnosed with hen's egg allergy or suspected of hen's egg allergy (egg white-specific IgE >= 0.35 kUA/L) by a medical doctor from up to 1 year before the temporary registration date (2)Aged 1-18 years (3)Informed written consent from patients or authorized guardians (patients aged >= 16 years gave their own written consent) Inclusion criteria for formal registration: (1)Patients temporarily registered who fulfill the inclusion criteria and do not conflict with the exclusion criteria for temporary registration, including the formal registration day (2)Patients diagnosed with hen's egg allergy by an oral challenge test with 10 g of a hen's egg (egg white and yolk) within 90 days after temporary registration (3)Patients with a cumulative tolerated dose of hen's egg determined by an oral challenge test with 10 g of a hen's egg (egg white and yolk)
Exclusion criteria
Exclusion criteria: Exclusion criteria for temporary registration: (1)Patients born before 37 weeks of gestation (2)Patients with siblings already enrolled (3)Immunosuppressant or systemic steroid administration (4)Patients planning to relocate or having difficulty making regular visits to our facility (5)Patients with severe complications (6)Allergy to rice, pumpkin, sugar beet, palm oil, cornstarch, baking powder, sweet potato, or trehalose (7)Patients considered unsuitable for the study by the lead researcher or co-researchers for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to onset of IgE-dependent immediate reaction after starting the experimental diet | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Secondary outcomes on effectiveness: (1) Change in cumulative tolerated dose on formal registration day to at 24 and 48 weeks after starting the experimental diet (2) Whether the oral challenge test of hen's egg is negative at 48 weeks after starting the experimental diet (3) Change in total IgE value on temporary registration day to that at 48 weeks after starting the experimental diet (4) Change in egg white- and ovomucoid-specific IgE value on temporary registration day to that at 24 and 48 weeks after starting the experimental diet (5) Change in egg white- and ovomucoid-specific IgG4 value on temporary registration day to that at 24 and 48 weeks after starting the experimental diet (6) Change in urinary PGDM (tetranor-PGDM, tetranor-PGEM) value 4 h after the intake of experimental diet on the starting day and at 4, 12, 24, 36, and 48 weeks (7) Ratio of urinary PGDM (tetranor-PGDM, tetranor-PGEM) value before and 4 h after the intake of experimental diet on the starting day and at 4, 12, 24, 36, and 48 weeks (8) Change in difference of urinary PGDM (tetranor-PGDM, tetranor-PGEM) value between before and 4 h after the intake of experimental diet on the starting day and at 4, 12, 24, 36, and 48 weeks 2.Secondary outcomes on safety: (1) Time to onset of IgE-dependent reaction after starting the experimental diet (2) The maximum severity score of IgE-dependent allergic reaction against hen's egg caused by experimental diet (3) Number of symptom days related to IgE-dependent allergic reaction against hen's egg (4) Presence or absence of anaphylaxis related to the experimental diet (5) Presence or absence of emergency room visits related to the experimental diet (6) Number and proportion of participants who experienced severe adverse reactions at least once (7) Number of participants who experienced severe adverse reactions, reaction appearance rate, and number of reactions (Continued in "Other related information") | — |
Countries
Japan
Contacts
Public ContactKiwako Yamamoto-Hanada
National Center for Child Health and Development Allergy Center
Outcome results
None listed