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

NCT ID: NCT03079206

Last Updated: 2020-11-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 83 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-22
• Study Completion Date: 2020-11-10

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.

Conditions

Food Allergy

Keywords

hazelnut; allergens; basophile-activation-test; food; allergy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Food challenge

Intervention Type: DIAGNOSTIC_TEST

food challenge with hazelnut

skin testing

Intervention Type: DIAGNOSTIC_TEST

Skin testing with hazelnut extract

blood sampling

Intervention Type: DIAGNOSTIC_TEST

blood sampling to perform basophile activation tests

Interventions

Food challenge

food challenge with hazelnut

Intervention Type: DIAGNOSTIC_TEST

skin testing

Skin testing with hazelnut extract

Intervention Type: DIAGNOSTIC_TEST

blood sampling

blood sampling to perform basophile activation tests

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

ADR-AC Laboratory, Berne

UNKNOWN

Sponsor Role: collaborator

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Barbara Ballmer-Weber, Prof.

Role: PRINCIPAL_INVESTIGATOR

Allergy Unit, Department of Dermatology, University Zürich

Locations

Allergy Unit, Department of Dermatology, University Hospital

Zurich, , Switzerland

Countries

Switzerland

Other Identifiers

2016-02152

Identifier Type: -

Identifier Source: org_study_id