Basophile Activation Testing (BAT) in Hazelnut Allergy (Hazelnut BAT Study) (NCT03079206) | Clinical Trial Compass
CompletedNot Applicable
Basophile Activation Testing (BAT) in Hazelnut Allergy (Hazelnut BAT Study)
Switzerland83 participantsStarted 2017-02-22
Plain-language 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.
Who can participate
Age range
14 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 th…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of patients with challenge confirmed food allergy to hazelnut and a positive basophile activation test