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

NCT03079206 | Completed

• 1 other identifier: 2016-02152
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

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.

Conditions

Food Allergy

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Hazelnut allergy

EXPERIMENTAL

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; Diagnostic Test: skin testing; Diagnostic Test: blood sampling

Interventions

Food challenge DIAGNOSTIC_TEST

food challenge with hazelnut

Hazelnut allergy

skin testing DIAGNOSTIC_TEST

Skin testing with hazelnut extract

Hazelnut allergy

blood sampling DIAGNOSTIC_TEST

blood sampling to perform basophile activation tests

Hazelnut allergy

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female subjects, age ≥ 14 years
• Informed Consent as documented by signature
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead
• ADR-AC Laboratory, Berne: collaborator

Study Sites (1)

Allergy Unit, Department of Dermatology, University Hospital

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Food Hypersensitivity; Hypersensitivity

Interventions

Skin Tests; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques; Specimen Handling; Punctures; Surgical Procedures, Operative

Study Officials

• Barbara Ballmer-Weber, Prof.

  Allergy Unit, Department of Dermatology, University Zürich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: In terms of study inclusion there will be no masking. Only the food challenge itself will be masked.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study intends to compare the outcome of food challenge with hazelnut and the in vitro basophile activation test using hazelnut extract and allergens

Study Record Dates

• First Submitted: February 20, 2017
• First Posted: March 14, 2017
• Study Start: February 22, 2017
• Primary Completion: November 10, 2020
• Study Completion: November 10, 2020
• Last Updated: November 13, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)