T78.1
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: -adults and children, age 1-67 years -suspected or known peanut and/or tree nut allergy -signed informed consent of patient/parents
Exclusion criteria
Exclusion criteria: - Other severe diseases (cardiac, cystic fibrosis, congenital) - participation in another interventional trial that requires consumption of food protein - uncontrolled asthma - usage of antihistamines 3-5 days before oral food challenge - therapy with beta-blocker and/or ACE-inhibitors - systemic immunosuppression - pregnancy or lactation - positiv oral food challenge to peanut and/or tree nut
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maintenance of clinical tolerance to peanut and/or tree nuts after one year assessed by feeding of the former tolerated cumulative dose. | — |
Secondary
| Measure | Time frame |
|---|---|
| -Maintenance of clinical tolerance to peanut after one year assessed by feeding of the former tolerated cumulative dose. -Maintenance of clinical tolerance to tree nuts in general and to individual tree nuts after one year assessed by feeding of the former tolerated cumulative dose. -Change in peanut- and/or tree nut- specific wheal size as well as IgE and IgG4 at 12 months from baseline. -Dietary compliance (frequency and amount of peanut and/or tree nut consumption) during the study, assessed by diaries, telephone interviews and during clinical visits. -Incidence, frequency, severity of immediate type allergic reactions to food during the study assessed by diaries, telephone interviews and during clinical visits. -Change in generic quality of life during and after the study from baseline assessed by questionnaires | — |
Countries
Germany
Contacts
Charité-Universitätsmedizin Berlin; Klinik für Pädiatrie m.S. Pneumologie und Immunologie mit Intensivmedizin