food allergy
Conditions
Interventions
The follow-up period is 52 weeks.From the start date to 4 weeks, the walnut group begins with 10mg of walnut-containing foods. However, if the pre-existing symptom-eliciting threshold is 10mg or less
Sponsors
National Hospital Organization Sagamihara National Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients aged 2 years or older and under 18 years at the time of trial treatment initiation (Day 1) Patients who tested positive for walnut at 0.8g or less (walnut protein amount 116.8mg) by oral food challenge test Patients from whom informed consent for participation in this study has been obtained from their legal guardian or from both the legal guardian and the patient
Exclusion criteria
Exclusion criteria: Patients with poorly controlled bronchial asthma (C-ACT or ACT score of 19 points or less) Patients with severe atopic dermatitis (Eczema Area and Severity Index: EASI score of 16 points or more) Patients undergoing other immunotherapy at the time of trial treatment initiation. However, patients who have been on sublingual immunotherapy (SLIT) or subcutaneous immunotherapy (SCIT) for cedar or dust mites for more than 1 year after initiation and are stable without adverse reactions may be permitted at the discretion of the attending physician. Patients using anti-human IgE antibody preparations, anti-human IL-5 monoclonal antibody preparations, anti-human IL-13 monoclonal antibody preparations, anti-human IL-5 receptor preparations, anti-human IL-4/IL-13 receptor preparations, anti-human IL-31 receptor preparations, anti-human TSLP monoclonal antibody preparations, or JAK inhibitors (oral) at the time of trial treatment initiation Patients using systemic steroids or immunosuppressive agents at the time of trial treatment initiation Patients with comorbid diseases that affect the immune system (autoimmune diseases, immune complex diseases, immunodeficiency disorders, etc.) Cases where the physician judges that trial execution would be difficult
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients achieving sustained unresponsiveness to 3.0g of walnut at 12 months from initiation | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients achieving desensitization to 0.4g of walnut at 12 months from the beginning of OIT Change in symptom-eliciting threshold in challenge tests at 12 months from the beginning of OIT Frequency of adverse events during the first 12 months Frequency of serious adverse events during the first 12 months Frequency of epinephrine intramuscular injection during the first 12 months Changes in walnut and walnut allergen component-specific IgE, IgG, and IgG4 levels during the first 12 months Changes in immune cell populations by single-cell analysis and interactome analysis Prediction of sustained unresponsiveness | — |
Countries
Japan
Contacts
Public ContactKen-ichi Nagakura
National Hospital Organization Sagamihara National Hospital Department of pediatrics
Outcome results
None listed