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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	14 Years and Over
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03079206
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of Zurich
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Barbara Ballmer-Weber, Prof.
Principal Investigator Affiliation	Allergy Unit, Department of Dermatology, University Zürich
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Active, not recruiting
Countries	Switzerland
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Food Allergy

Additional Details

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.

Arms & Interventions

Arms

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

Interventions

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

Contact a Trial Team

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International Sites

Zürich, Switzerland

Status

Address

Allergy Unit, Department of Dermatology, University Hospital

Zürich, , 8091

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