Basophil Activation Test to Diagnose Food Allergy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-30

Study Completion Date

2021-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The BAT II Study is a cross-sectional diagnostic study in which children with suspected IgE-mediated allergy to foods (namely cow's milk, egg, sesame and cashew), as defined by a history of an immediate-type allergic reaction to a food or no history of food consumption or the presence of food-specific IgE as documented by skin prick test or serum specific IgE, will undergo a diagnostic work-up to confirm or refute the diagnosis of IgE-mediated food allergy. Participants will be prospectively recruited from specialised Paediatric Allergy clinics in London and will undergo skin prick testing (SPT), specific IgE testing to allergen extracts and allergen components, basophil activation test (BAT) and oral food challenge. The diagnostic accuracy of the BAT and of other allergy tests will be assessed against the clinical gold-standard.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Clinical Impact of the Basophil Activation Test to Diagnose Food Allergy

NCT05309772

Food Allergy Food Allergy in Infants Food Allergy in Children +4 more

UNKNOWN NA

Basophil Activation Test (BAT) Sensitivity in Child Food Allergy

NCT01966640

Allergy to Egg Allergy to Peanut

COMPLETED PHASE4

The Basophil Activation Test For Egg Allergy

NCT06559319

Food Allergy

ACTIVE_NOT_RECRUITING

The Basophil Activation Test as a Diagnostic Tool in Pediatric Food Allergy

NCT03265262

FOOD ALLERGY

COMPLETED NA

BAT Cow's Milk for the Replacement of the Food Challenge Test

NCT05064917

Cow Milk Allergy

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Food Allergy Food Allergy in Infants Food Allergy in Children Food Allergen Sensitisation Milk Allergy Egg Allergy Nut Allergy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Food allergic

Patients with a positive oral challenge to the food being studied.

Oral food challenge

Intervention Type DIAGNOSTIC_TEST

Patients with suspected food allergy will undergo clinical and dietary assessments and oral food challenge. Different allergy tests will be performed, including skin prick test, specific IgE test and basophil activation test, and its diagnostic utility will be determined against the clinical gold-standard.

Non food allergic

Patients with a negative oral challenge to the food being studied.

Oral food challenge

Intervention Type DIAGNOSTIC_TEST

Patients with suspected food allergy will undergo clinical and dietary assessments and oral food challenge. Different allergy tests will be performed, including skin prick test, specific IgE test and basophil activation test, and its diagnostic utility will be determined against the clinical gold-standard.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Oral food challenge

Patients with suspected food allergy will undergo clinical and dietary assessments and oral food challenge. Different allergy tests will be performed, including skin prick test, specific IgE test and basophil activation test, and its diagnostic utility will be determined against the clinical gold-standard.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Basophil activation test Skin prick test Specific IgE test

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Children ≥6 months and \<16 years old;
2. Suspected IgE-mediated food allergy defined by:

* History of an immediate-type allergic reaction to a specific food or
* No history of consumption of the specific food or
* IgE sensitisation documented by skin prick test (≥1 mm) or serum specific IgE (≥0.10 KU/L);
3. Avoidance of the specific food for at least 2 days prior to blood collection for BAT and specific IgE and prior to the challenge;
4. Informed consent obtained from parent or guardian and assent obtained from the child.

Exclusion Criteria

1. Clinically significant chronic illness other than atopic diseases;
2. Previous history of severe life-threatening reaction to the suspected food with documented decrease in oxygen saturation (\<90%), hypotension (≥20% reduction in systolic blood pressure) and/or admission to intensive care;
3. Unwillingness to comply with study procedures, namely to undergo a diagnostic food challenge;
4. Contra-indication for diagnostic food challenge, namely:

* Uncontrolled atopic diseases (e.g. eczema, asthma, rhinitis);
* Chronic medical conditions that pose significant risk in the event of anaphylaxis or treatment of anaphylaxis (e.g. cardiac disease, severe lung disease, pregnancy, mastocytosis);
* Inability to discontinue medications that might interfere with assessment or safety (e.g. antihistamines, β-agonists, β-blockers, NSAIDs, ACE inhibitor, antacids);
* Recent (within 7-14 days) treatment with systemic steroids or prolonged high-dose systemic steroids or immunosuppressants;
5. Undergoing treatment with omalizumab, food allergen immunotherapy or other systemic immunomodulatory treatment;
6. Inability to stop anti-histamines prior to SPT.

Minimum Eligible Age

6 Months

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No