Tolerance induction through non-avoidance to prevent persistent food allergy

Not Applicable

Recruiting

Conditions: T78.1
Other adverse food reactions, not elsewhere classified

Registration Number: DRKS00016764

Lead Sponsor: Charité-Universitätsklinikum Berlin

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 120

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

- 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
- allergic reaction to less than the 5th dose of peanut and/or tree nut protein during oral food challenge

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical tolerance to peanut or tree nuts after one year assessed by oral food challenge (up to the repetitive cumulative dose).

Secondary Outcome Measures

Name	Time	Method
-Clinical tolerance to peanut after one year assessed by oral food challenge <br>-Clinical tolerance to tree nuts in general and to individual tree nuts after one year assessed by oral food challenge.<br>-Change in threshold level upon oral peanut or tree nut challenge after one year.<br>-Change in peanut- and/or tree nut- specific wheal size as well as IgE and IgG4 at 12 months from baseline.<br>-Incidence, frequency, severity and relatedness of (serious) adverse events, especially immediate type allergic reactions and gastrointestinal problems, including accidental allergic reactions during the study assessed by diaries, telephone interviews and during clinical visits.<br>-Change of SCORAD, EASIscore and topical eczema treatment in participants with atopic dermatitis at 4, 8 and 12 months from baseline.<br>-Change in generic and disease specific quality of life during and after the study from baseline assessed by questionnaires <br>