Food AllergyBAT2NCT03309488
Basophil Activation Test to Diagnose Food Allergy
An observational study of Food Allergy and Food Allergy in Infants, run by King's College London at 1 site in United Kingdom.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 6 months to 16 years
- Conditions the study is for
- Food Allergy, Food Allergy in Infants, Food Allergy in Children
- What is being tested?
- Oral food challenge
- Type of treatment
- Pill or oral medicine
- How many people
- 600 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Jan 2018to 31 Jul 2021
- Phase
- Observational
- 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 6 months to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Children seen in specialized Pediatric Allergy clinics with suspected allergy to one of the foods studied, namely milk, egg, sesame and nuts.
Who may be able to join
- Children ≥6 months and <16 years old;
- 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);
- Avoidance of the specific food for at least 2 days prior to blood collection for BAT and specific IgE and prior to the challenge;
- Informed consent obtained from parent or guardian and assent obtained from the child.
Who cannot join
- Clinically significant chronic illness other than atopic diseases;
- 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;
- Unwillingness to comply with study procedures, namely to undergo a diagnostic food challenge;
- 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);
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- 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;
- Undergoing treatment with omalizumab, food allergen immunotherapy or other systemic immunomodulatory treatment;
- Inability to stop anti-histamines prior to SPT.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Pediatric Allergy Clinical Research Facility, Evelina Children's Hospital
London, SE17EH
Monica Basting, monica.basting@kcl.ac.uk
Alexandra Santos, MD PhD
About this study
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.
- Conditions
- Food Allergy, Food Allergy in Infants, Food Allergy in Children, Food Allergen Sensitisation, Milk Allergy, Egg Allergy
- Being tested
- Oral food challenge
- Keywords
- Food allergy, Milk allergy, Egg allergy, Nut allergy, Basophil activation test, Diagnosis, Specific IgE, Skin prick test
- Medical subject headings
- Food Hypersensitivity, Milk Hypersensitivity, Egg Hypersensitivity, Nut Hypersensitivity, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral food challengeDiagnostic test
Also called Basophil activation test, Skin prick test, Specific IgE 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.
| Study group | Role | What they receive |
|---|---|---|
| Food allergic | Patients with a positive oral challenge to the food being studied. Receives: Diagnostic Test: Oral food challenge | |
| Non food allergic | Patients with a negative oral challenge to the food being studied. Receives: Diagnostic Test: Oral food challenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of the basophil activation test (for each individual food allergy)
Accuracy of %CD63+ basophils
Measured: 3 years
Secondary outcomes (3)
Diagnostic accuracy of SPT, specific IgE to extracts and to single allergens
Accuracy of weal diameter or level of IgE
Measured: 3 years
Association between BAT and severity of symptoms during challenges
Correlation between %CD63+ basophils and severity grade
Measured: 3 years
Association between BAT and threshold of reactivity during challenges
Correlation between CD-sens and cumulative threshold dose
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2017
- Study start30 Jan 2018
- Primary completion31 Jul 2021 (estimated)
- Study completion31 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Alexandra Santos, MD PhD, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03309488
- Sponsor's protocol ID
- IRAS 197886
- Acronym
- BAT2
- Status last verified
- Sep 2020
- First submitted
- 7 Jul 2017
- Last updated
- 2 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bartha I, Boyd H, Foong RX, Krawiec M, Marques-Mejias A, Marshall HF, Radulovic S, Harrison F, Antoneria G, Jama Z, Kwok M, Pietraszewicz E, Eghleilib M, Ricci C, Marrs T, Lack G, Du Toit G, Santos AF. The Basophil Activation Test Is the Most Accurate Test in Predicting Allergic Reactions to Baked and Fresh Cow's Milk During Oral Food Challenges. Allergy. 2025 Oct;80(10):2861-2873. doi: 10.1111/all.16675. Epub 2025 Aug 13.
PubMed 40808324Marques-Mejias A, Radulovic S, Foong RX, Bartha I, Krawiec M, Kwok M, Jama Z, Harrison F, Ricci C, Lack G, Du Toit G, Santos AF. Partial Egg Consumption Modifies the Diagnostic Performance of Allergy Tests to Predict Outcome of Double-Blind Placebo-Controlled Food Challenges to Egg. J Allergy Clin Immunol Pract. 2024 Mar;12(3):660-669.e5. doi: 10.1016/j.jaip.2023.12.036. Epub 2023 Dec 27.
PubMed 38157981
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Basophil Activation Test to Diagnose Food Allergy
- ClinicalTrials.gov ID
- NCT03309488
- Acronym / sponsor ID
- BAT2 / IRAS 197886
- Conditions
- Food Allergy, Food Allergy in Infants, Food Allergy in Children, Food Allergen Sensitisation, Milk Allergy, Egg Allergy
- Keywords
- Food allergy, Milk allergy, Egg allergy, Nut allergy, Basophil activation test, Diagnosis, Specific IgE, Skin prick test
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust
- Study start
- 30 Jan 2018 (actual)
- Primary completion
- 31 Jul 2021 (estimated)
- Study completion
- 31 Jul 2021 (estimated)
- First posted
- 13 Oct 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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Food allergic | – | Diagnostic Test: Oral food challengePatients with a positive oral challenge to the food being studied. |
| Non food allergic | – | Diagnostic Test: Oral food challengePatients with a negative oral challenge to the food being studied. |
Who may qualify
- Ages
- 6 months to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children seen in specialized Pediatric Allergy clinics with suspected allergy to one of the foods studied, namely milk, egg, sesame and nuts.
Key inclusion criteria (7 listed)
- Children ≥6 months and <16 years old;
- Suspected IgE-mediated food allergy defined by:
- Avoidance of the specific food for at least 2 days prior to blood collection for BAT and specific IgE and prior to the challenge;
- Informed consent obtained from parent or guardian and assent obtained from the child.
Key exclusion criteria (10 listed)
- Clinically significant chronic illness other than atopic diseases;
- 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;
- Unwillingness to comply with study procedures, namely to undergo a diagnostic food challenge;
- Contra-indication for diagnostic food challenge, namely:
- Undergoing treatment with omalizumab, food allergen immunotherapy or other systemic immunomodulatory treatment;
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 |
|---|---|---|
| Oral food challengeAlso: Basophil activation test, Skin prick test, Specific IgE testPatients 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. | Diagnostic test | Food allergic, Non food allergic |
Primary outcome
Diagnostic accuracy of the basophil activation test (for each individual food allergy)
Time frame: 3 years
Accuracy of %CD63+ basophils
3 secondary outcomes
Diagnostic accuracy of SPT, specific IgE to extracts and to single allergens
Time frame: 3 years
Association between BAT and severity of symptoms during challenges
Time frame: 3 years
Association between BAT and threshold of reactivity during challenges
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2020.
- Derived from this study: PubMed 40808324Bartha I, Boyd H, Foong RX, Krawiec M, Marques-Mejias A, Marshall HF, Radulovic S, Harrison F, Antoneria G, Jama Z, Kwok M, Pietraszewicz E, Eghleilib M, Ricci C, Marrs T, Lack G, Du Toit G, Santos AF. The Basophil Activation Test Is the Most Accurate Test in Predicting Allergic Reactions to Baked and Fresh Cow's Milk During Oral Food Challenges. Allergy. 2025 Oct;80(10):2861-2873. doi: 10.1111/all.16675. Epub 2025 Aug 13.
- Derived from this study: PubMed 38157981Marques-Mejias A, Radulovic S, Foong RX, Bartha I, Krawiec M, Kwok M, Jama Z, Harrison F, Ricci C, Lack G, Du Toit G, Santos AF. Partial Egg Consumption Modifies the Diagnostic Performance of Allergy Tests to Predict Outcome of Double-Blind Placebo-Controlled Food Challenges to Egg. J Allergy Clin Immunol Pract. 2024 Mar;12(3):660-669.e5. doi: 10.1016/j.jaip.2023.12.036. Epub 2023 Dec 27.
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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.
Alexandra Santos, MD PhD principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Food Allergy and Food Allergy in Infants, run by King's College London at 1 site in United Kingdom.
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 10 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: status not confirmed, as of the sponsor's last update on 2 Sep 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 United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexandra Santos, MD PhD (+442071886424, alexandra.santos@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of the basophil activation test (for each individual food allergy) (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03309488, which also lists 2 linked publications.
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 2 Sep 2020.