Food allergy
Conditions
Interventions
Participants will undergo both challenges for the specific potential food
allergen. As patients and/or their parents might be reluctant to perform a
second test if symptoms occurred during the first
Sponsors
Martini Ziekenhuis
Eligibility
Age
2 Years to 17 Years
Inclusion criteria
Inclusion criteria: Children from four till eighteen years old for whom it is recommended to perform an OFC for a suspected food allergy for cashew nut, hazelnut or peanut will be eligible for inclusion.
Exclusion criteria
Exclusion criteria: Patients will be excluded if they use beta blockers and/or prednisolone, if they suffer from uncontrolled asthma, unstable angina pectoris, fever or if the patient reported to be pregnant. Patients should also be able to adequately report the occurrence of possible symptoms and will be excluded if they are not able to do so (e.g. mentally disabled or not native Dutch speaker).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure will be the difference in the proportion of positive outcomes of the DBPCFC and the open food challenge. Children who had a positive DBPCFC outcome but are not willing to perform the open food challenge will also be defined as a positive open food challenge. | — |
Secondary
| Measure | Time frame |
|---|---|
| The following secondary outcome measures will be analysed: eliciting dose (i.e. first dose that causes allergic symptoms) and stopping dose (i.e. cumulative total dose that has been eaten), occurrence of symptoms on all challenge days (objective, subjective and severity), percentage of false positive reactions (i.e. the occurrence of allergic symptoms on placebo day in case of DBPCFC) and percentage of successful introduction into diet (if OFC outcome is negative). Furthermore, we keep record of patients for whom an open food challenge might be indicated as first choice to investigate the added value of DBPCFC in these patients. | — |
Countries
Netherlands
Outcome results
None listed