Back to resultsBasophile Activation Testing (BAT) in Hazelnut Allergy (Hazelnut BAT Study)
Primary Purpose
Food Allergy
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Food challenge
skin testing
blood sampling
Sponsored by
About this trial
This is an interventional diagnostic trial for Food Allergy focused on measuring hazelnut, allergens, basophile-activation-test, food, allergy
Eligibility Criteria
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
Sites / Locations
- Allergy Unit, Department of Dermatology, University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Hazelnut allergy
Arm Description
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
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT03079206
First Posted
February 20, 2017
Last Updated
November 12, 2020
Sponsor
University of Zurich
Collaborators
ADR-AC Laboratory, Berne
1. Study Identification
Unique Protocol Identification Number
NCT03079206
Brief Title
Basophile Activation Testing (BAT) in Hazelnut Allergy (Hazelnut BAT Study)
Official Title
Correlation of the in Vivo Food Provocation Test With the in Vitro Basophile Activation Test in Hazelnut Allergic Patients
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
February 22, 2017 (Actual)
Primary Completion Date
November 10, 2020 (Actual)
Study Completion Date
November 10, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
Collaborators
ADR-AC Laboratory, Berne
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Food Allergy
Keywords
hazelnut, allergens, basophile-activation-test, food, allergy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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
Masking
None (Open Label)
Masking Description
In terms of study inclusion there will be no masking. Only the food challenge itself will be masked.
Allocation
N/A
Enrollment
83 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hazelnut allergy
Arm Type
Experimental
Arm Description
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
Intervention Type
Diagnostic Test
Intervention Name(s)
Food challenge
Intervention Description
food challenge with hazelnut
Intervention Type
Diagnostic Test
Intervention Name(s)
skin testing
Intervention Description
Skin testing with hazelnut extract
Intervention Type
Diagnostic Test
Intervention Name(s)
blood sampling
Intervention Description
blood sampling to perform basophile activation tests
Primary Outcome Measure Information:
Title
Number of patients with challenge confirmed food allergy to hazelnut and a positive basophile activation test
Description
outcome of food challenge in hazelnut allergic patients will be compared to the outcome of basophile activation using hazelnut extract and allergens
Time Frame
up to 3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara Ballmer-Weber, Prof.
Organizational Affiliation
Allergy Unit, Department of Dermatology, University Zürich
Official's Role
Principal Investigator
Facility Information:
Facility Name
Allergy Unit, Department of Dermatology, University Hospital
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
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Basophile Activation Testing (BAT) in Hazelnut Allergy (Hazelnut BAT Study)
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