Food AllergyNCT03079206
Basophile Activation Testing (BAT) in Hazelnut Allergy (Hazelnut BAT Study)
A study testing Food challenge, skin testing and blood sampling in people with Food Allergy, run by University of Zurich at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 14 years and olderHealthy volunteers can take part
- Conditions the study is for
- Food Allergy
- What is being tested?
- Food challenge, skin testing and blood sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteSwitzerland
- Study dates
- 22 Feb 2017to 10 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Allergy Unit, Department of Dermatology, University Hospital
Zurich, 8091
About this study
Official title: 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.
Read the 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
- Being tested
- Food challenge, skin testing, blood sampling
- Keywords
- hazelnut, allergens, basophile-activation-test, food, allergy
- Medical subject headings
- Food Hypersensitivity, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food challengeDiagnostic test
food challenge with hazelnut
skin testingDiagnostic test
Skin testing with hazelnut extract
blood samplingDiagnostic test
blood sampling to perform basophile activation tests
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Food challenge; Diagnostic Test: skin testing; Diagnostic Test: blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2017
- Study start22 Feb 2017
- Primary completion10 Nov 2020
- Study completion10 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food AllergyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- ADR-AC Laboratory, Berne
- Responsible party
- Sponsor
- Investigators
- Barbara Ballmer-Weber, Prof., Principal investigator, Allergy Unit, Department of Dermatology, University Zürich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03079206
- Sponsor's protocol ID
- 2016-02152
- Other IDs
- 2016
- Status last verified
- Nov 2020
- First submitted
- 20 Feb 2017
- Last updated
- 13 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of the in Vivo Food Provocation Test With the in Vitro Basophile Activation Test in Hazelnut Allergic Patients
- ClinicalTrials.gov ID
- NCT03079206
- Acronym / sponsor ID
- 2016-02152
- Conditions
- Food Allergy
- Keywords
- hazelnut, allergens, basophile-activation-test, food, allergy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- ADR-AC Laboratory, Berne
- Study start
- 22 Feb 2017 (actual)
- Primary completion
- 10 Nov 2020 (actual)
- Study completion
- 10 Nov 2020 (actual)
- First posted
- 14 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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
| Arm | Type | Receives |
|---|---|---|
| Hazelnut allergy | Experimental | Diagnostic Test: Food challenge, Diagnostic Test: skin testing, Diagnostic Test: blood samplingpatients with positive case history of hazelnut allergy and a positive skin testing are undergoing a food challenge and blood sampling for basophile activation testing |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Food challengefood challenge with hazelnut | Diagnostic test | Hazelnut allergy |
| skin testingSkin testing with hazelnut extract | Diagnostic test | Hazelnut allergy |
| blood samplingblood sampling to perform basophile activation tests | Diagnostic test | Hazelnut allergy |
Primary outcome
Number of patients with challenge confirmed food allergy to hazelnut and a positive basophile activation test
Time frame: up to 3 years
outcome of food challenge in hazelnut allergic patients will be compared to the outcome of basophile activation using hazelnut extract and allergens
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
- Individual participant dataSharing planned: No
Related trials for Food Allergy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara Ballmer-Weber, Prof. principal investigator
Allergy Unit, Department of Dermatology, University Zürich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food challenge, skin testing and blood sampling in people with Food Allergy, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with challenge confirmed food allergy to hazelnut and a positive basophile activation test (time frame: up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2020.