T78.1 T78.0
Conditions
Interventions
Group 1: At study entry all patients undergo an oral food challenge to peanut. Children of the Verum-group receive samll amounts of a chocolate dessert with peanut flour of roasted peanuts on a daily
Sponsors
Klinik für Pädiatrie mit Schwerpunkt Pneumologie und Immunologie
Universitätsmedizin Charité Berlin- CVK
Eligibility
Sex/Gender
All
Age
3 Years to 18 Years
Inclusion criteria
Inclusion criteria: Children with 1. a sensitization against peanut (peanut-specific IgE > 0.35 kU/l) 2. challenge-proven clinical relevant peanut allergy 3. signed informed consent by the mother and father of the child 4. mother or father being mentally as well as verbally capable of understanding the proposed intention and intervention of the study
Exclusion criteria
Exclusion criteria: Children with 1. ongoing treatment of another form of immunotherapy (e.g. systemic or sublingual immunotherapy against pollen) during the study period 2. participation in another interventional study trial 3. other severe diseases (following the clinical judgement of the study physician)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome will be the comparison between the number of patients in both groups (Placebo/ Verum) who tolerate 500mg of whole peanut or more at final oral challenge after the end of the study (visit 3), after finished oral immunotherapy/Placebo-therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| As a secondary outcome the number of patients who will not react to the maximum dose of peanut at final challenge after the end of the study (visit 3) will be compared in both groups (Placebo/ Verum). Furthermore changes in threshold levels between baseline (visit 1, prior to oral immunotherapy) and final oral peanut challenge (visit 3, post oral immunotherapy) of patients receiving Verum/ Placebo therapy will be compared intraindividually as well as between these two groups. Total number of objective allergic adverse events per total oral immunotherapy-doses will be compared in patients of the Verum and the placebo group (V1 to V3). In addition the total number of allergic adverse events requiring medical intervention per total oral immunotherapy-doses will be compared in patients of the Verum and the placebo group. Changes in quality of life and burden of treatment, which will be assessed in all children and their mothers before and after completion of the study (4-5 weeks after visit 3) using the FAQLQ-CF, FAQLQ-TF, FAQLQ-PF- questionnaires and BOT-CF, BOT-TF, BOT-PF- questionnaires respectively, will be evaluated separately and compared in both groups (Verum/Placebo). Furthermore changes in peanut-specific T-cell and B cell responses and basophil reactivity will be measured in vitro before (visit 1) and after oral immunotherapy-study (visit 3) and both groups will be evaluated separately and compared with each other. | — |
Countries
Germany
Contacts
Public ContactKatharina Blümchen
Klinik für Pädiatrie mit Schwerpunkt Pneumologie und Immunologie Universitätsmedizin Charité Berlin- CVK
Outcome results
None listed