Basophile Activation Testing (BAT) in Hazelnut Allergy (Hazelnut BAT Study)

Food Allergy Clinical Trial

Official title:

Correlation of the in Vivo Food Provocation Test With the in Vitro Basophile Activation Test in Hazelnut Allergic Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03079206
• Other study ID #: 2016-02152
• Status: Completed
• Phase: N/A
• Start date: February 22, 2017
• Est. completion date: November 10, 2020

Study information

• Verified date: November 2020
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: November 10, 2020
• Est. primary completion date: November 10, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Food Allergy
• Food Hypersensitivity
• Hypersensitivity

Intervention

Diagnostic Test:
• Food challenge
food challenge with hazelnut
• skin testing
Skin testing with hazelnut extract
• blood sampling
blood sampling to perform basophile activation tests

Locations

Country	Name	City	State
Switzerland	Allergy Unit, Department of Dermatology, University Hospital	Zürich

Sponsors (2)

Lead Sponsor	Collaborator
University of Zurich	ADR-AC Laboratory, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with challenge confirmed food allergy to hazelnut and a positive basophile activation test	outcome of food challenge in hazelnut allergic patients will be compared to the outcome of basophile activation using hazelnut extract and allergens	up to 3 years