Nut allergy
Conditions
Interventions
Sublingual immunotherapy using nut powder purchased, ground, and packaged by the investigators. The initial dose is 0.01 g administered in the hospital. The powder is measured using the hollow of an E
Sponsors
University of Toyama
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Children aged 5 years to under 13 years 2) Suspected immediate-type allergy to nuts and positive serum specific IgE (ImmunoCAP, >=0.35 UA/mL) 3) Written informed consent from parents/guardians and assent from the child when applicable 4) Judged medically appropriate for participation by the treating physician
Exclusion criteria
Exclusion criteria: 1) Poorly controlled asthma (visit for asthma or steroid use within the past 3 months) 2) Other severe chronic diseases such as heart disease, immunodeficiency, or collagen disease 3) Severe developmental delay or behavioral problems making continuation difficult 4) Participation in another clinical study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum tolerated dose (g) in oral food challenge at 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Maximum tolerated dose (g) in oral food challenge at 12 months 2) Changes in blood count, total IgE, nut-specific IgE, and TARC at baseline, 6, 12, 18, and 24 months 3) Incidence of systemic allergic reactions, anaphylaxis, adrenaline auto-injector use, and hospitalization-requiring adverse events during treatment 4) Frequency of local symptoms during treatment (oral discomfort, pharyngeal itching, lip swelling, local rash, mild rhinorrhea, sneezing, conjunctival injection) 5) Continuation rate of sublingual immunotherapy at 24 months 6) Achievement status of dose escalation | — |
Countries
Japan
Contacts
Public ContactShokei Murakami
University of Toyama Hospital Department of Pediatrics
Outcome results
None listed