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

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

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.

Study Overview

• Status: Completed
• Conditions: Food Allergy
• Intervention / Treatment: Diagnostic test: Food challenge; Diagnostic test: skin testing; Diagnostic test: blood sampling

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.

• Study Type: Interventional
• Enrollment (Actual): 83
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zürich, Switzerland, 8091
    • Allergy Unit, Department of Dermatology, University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hazelnut allergy; patients with positive case history of hazelnut allergy and a positive skin testing are undergoing a food challenge and blood sampling for basophile activation testing	Diagnostic test: Food challenge; food challenge with hazelnut; Diagnostic test: skin testing; Skin testing with hazelnut extract; Diagnostic test: blood sampling; blood sampling to perform basophile activation tests

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Zurich
• Collaborators: ADR-AC Laboratory, Berne
• Investigators: Principal Investigator: Barbara Ballmer-Weber, Prof., Allergy Unit, Department of Dermatology, University Zürich

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2017
• Primary Completion (Actual): November 10, 2020
• Study Completion (Actual): November 10, 2020

Study Registration Dates

• First Submitted: February 20, 2017
• First Submitted That Met QC Criteria: March 7, 2017
• First Posted (Actual): March 14, 2017

Study Record Updates

• Last Update Posted (Actual): November 13, 2020
• Last Update Submitted That Met QC Criteria: November 12, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: food; allergy; hazelnut; allergens; basophile-activation-test
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Food Hypersensitivity
• Other Study ID Numbers: 2016-02152

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No