Food Allergy
Conditions
Keywords
hazelnut, allergens, basophile-activation-test, food, allergy
Brief summary
The proposed study intends to compare the outcome of food challenge in hazelnut allergic patients with the outcome of basophile activation tests using hazelnut extract and components.
Detailed description
Accurate diagnosis of food allergy depends on food challenge outcome. The proposed study intends to compare the outcome of food challenge in hazelnut allergic patients with the outcome of basophile activation tests using hazelnut extract and components to evaluate the diagnostic utility of basophile activation testing. With a view towards improved in vitro diagnostic methods, the investigators intend to evaluate the diagnostic potential of basophile activation testing in patients with hazelnut allergy confirmed by a positive provocation or supported by a convincing history of anaphylactic reaction(s) to hazelnut in the past, patients with pollinosis but no symptoms of hazelnut allergy and non-atopic control subjects.
Interventions
DIAGNOSTIC_TESTFood challenge
food challenge with hazelnut
DIAGNOSTIC_TESTskin testing
Skin testing with hazelnut extract
DIAGNOSTIC_TESTblood sampling
blood sampling to perform basophile activation tests
Sponsors
ADR-AC Laboratory, Berne
University of Zurich
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
In terms of study inclusion there will be no masking. Only the food challenge itself will be masked.
Intervention model description
The study intends to compare the outcome of food challenge with hazelnut and the in vitro basophile activation test using hazelnut extract and allergens
Eligibility
Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Primary Inclusion criteria: * Male and female subjects, age ≥ 14 years * Informed Consent as documented by signature Secondary inclusion criterion * Group A: positive case history of allergic reaction(s) to hazelnut positive double-blind placebo-controlled food challenge with hazelnut or positive titrated open food challenge with hazelnut or unambiguous case history of an anaphylactic reaction after hazelnut will be included without provocation * Group B:positive skin test (SPT) with birch pollen and hazelnut and negative food provocation with hazelnut. * Group C: negative case history of hazelnut and birch allergy and negative skin test (SPT) with hazelnut and birch pollen and negative food provocation with hazelnut
Exclusion criteria
* Drugs not allowed due to interference with the food challenge (or shortest interval between last treatment and food challenge): corticosteroids systemically (2 weeks), antihistamines (3 days), beta blocker (1 day), angiotensin converting enzyme (ACE) inhibitors (2 days), omalizumab (2 months) * Women who are pregnant * Lack of safe contraception * Uncontrolled asthma, forced expiratory volume (1 second) \<70% predicted value * Acute allergic disease * Chronic urticaria * Mastocytosis * Other clinically significant concomitant disease states * Known or suspected non-compliance, drug or alcohol abuse, * Inability to follow the procedures of the study * Participation in another study with investigational drug within the 30 days preceding and during the present study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with challenge confirmed food allergy to hazelnut and a positive basophile activation test | up to 3 years | outcome of food challenge in hazelnut allergic patients will be compared to the outcome of basophile activation using hazelnut extract and allergens |
Countries
Switzerland
Outcome results
None listed