Food allergy
Conditions
Interventions
Consume weaning food with peanuts, walnuts, and cashews at least twice a week from 1 year to 1 year and 6 months
Consume placebo weaning food at least twice a week from 1 year to 1 year and 6 months
Sponsors
National Hospital Organization Sagamihara National Hospital
Miyagi Children'
s Hospital Aichi Children'
s Health and Medical Center Showa Medical University Hospital National Hospital Organization Mie National Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Infants under 1 year of age at the time of study enrollment who have sensitization to one or more food allergens by blood test between 6 to 11 months of age.
Exclusion criteria
Exclusion criteria: Severe atopic dermatitis Infants with a history of immediate symptoms to peanuts, walnuts, or cashews Infants with sensitization to peanuts, walnuts, cashews, Ara h 2, Jug r 1, or Ana o 3 by blood test Infants with concomitant immune disorders Infants with a history or complications of cardiac, liver, kidney, or blood disease Infants using systemic steroids regularly Infants using systemic biologics Decision of ineligibility by a physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitization to peanut, walnut, and cashew at the age of two | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of patients with allergic symptoms to peanuts, walnuts, or cashews at age two Percentage of patients with allergic symptoms to foods other than peanuts, walnuts, and cashews at age two Percentage of patients with sensitization to peanuts, walnuts, cashews, Ara h 2, Jug r 1, Ana o 3, respectively, up to two years of age Specific IgE level for peanuts, walnuts, cashews, Ara h 2, Jug r 1, Ana o 3, at 1 year 6 months and 2 years Specific IgG and IgG4 level for peanuts, walnuts, and cashews at 1 year 6 months and 2 years The results of peanut, walnut, and cashew oral food challenge test in sensitized children Safety and adverse events related to the trial weaning food Frequency of trial weaning food intake | — |
Countries
Japan
Contacts
Public ContactNoriyuki Yanagida
National Hospital Organization Sagamihara National Hospital Pediatrics
Outcome results
None listed