Tolerance induction through non-avoidance to prevent persistent food allergy

Recruiting

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

Registration Number: DRKS00020467

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
- positiv oral food challenge to peanut and/or tree nut

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Maintenance of clinical tolerance to peanut and/or tree nuts after one year assessed by feeding of the former tolerated cumulative dose.

Secondary Outcome Measures

Name	Time	Method
-Maintenance of clinical tolerance to peanut after one year assessed by feeding of the former tolerated cumulative dose.<br>-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.<br>-Change in peanut- and/or tree nut- specific wheal size as well as IgE and IgG4 at 12 months from baseline.<br>-Dietary compliance (frequency and amount of peanut and/or tree nut consumption) during the study, assessed by diaries, telephone interviews and during clinical visits.<br>-Incidence, frequency, severity of immediate type allergic reactions to food during the study assessed by diaries, telephone interviews and during clinical visits.<br>-Change in generic quality of life during and after the study from baseline assessed by questionnaires