Food Allergy
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients who have undergone oral food challenge tests, and demonstrated a symptom score of 10 (skin symptom) or 11 (10 of skin symptom plus 1)according to the Anaphylaxis Scoring Aichi (ASCA).
Exclusion criteria
Exclusion criteria: Patients who have a poor physical condition, such as suffering from a cold before undergoing the oral food challenge tests. Patients who had orally taken antihistamines, leukotriene receptor antagonists, beta 2 stimulants, Th 2 cytokine inhibitors, theophylline, or oral sodium cromoglycate within 72 hours before the oral food challenge tests. Patients who received oral or intravenous steroids within 2 weeks before undergoing the oral food challenge tests. Patients that the doctor assessed as being ineligible for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The ratio of patients who experienced a worsening the ASCA total score by 10 points or more until the end of the oral food challenge according to intention to treat analysis | — |
Secondary
| Measure | Time frame |
|---|---|
| The ratio of patients who experienced a worsening the ASCA total score by 10 points or more until the end of the oral food challenge according to per protocol analysis. The ratio of patients who experienced a worsening the ASCA total score by 10 points or more until the end of the oral food challenge, while excluding cases where the ASCA score deteriorated by 10 points or more before the administration of any drugs. The analysis of the efficacy of steroids was stratified according to each organ symptom. The efficacy of the steroids to suppress anaphylaxis and anaphylaxy shock. The analysis of the efficacy of steroids corrected by age, sex, past history of asthma and atopic dermatitis, antigen specific-IgE titer etc. | — |
Countries
Japan
Contacts
Aichi Children's Health and Medical Center Department of Allergy