Food AllergyNCT05309772
The Clinical Impact of the Basophil Activation Test to Diagnose Food Allergy
A study testing Basophil activation test (BAT) and Oral food challenge (OFC) in people with Food Allergy and Food Allergy in Infants, run by King's College London at 11 sites in United Kingdom.
Trial summary
The BAT Impact study is a prospective multicentre study in the UK using a biomarker-led study design to compare the incidence of adverse events (defined as allergic reactions during oral food challenges) in a randomized-controlled trial. Patients will either follow the standard-of-care (i.e. Read more about this study
- Who is it for?
- Ages 6 months to 15 years
- Conditions the study is for
- Food Allergy, Food Allergy in Infants, Food Allergy in Children
- What is being tested?
- Basophil activation test (BAT) and Oral food challenge (OFC)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 398 participants
- Where
- 11 sitesUnited Kingdom
- Study dates
- 13 Jan 2023to Jul 2025
- 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 6 months to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children and young people aged 6 months to 15 years
- Suspected allergy to one of the study foods (peanut, cow's milk, egg, cashew, sesame) - defined as:
- history of clinical reaction or
- evidence of IgE sensitisation (SPT>0mm and/or specific IgE>=0.10 KU/L) to the respective food or
- reassessment for possible resolution of allergy to the specific food following previous diagnosis of food allergy
- Need for an oral food challengeOFC to the study food
- Oral food challengeOFC to reach amount of food protein in a typical portion size for child's age
- Consent from adults with parental responsibility and assent from children and young people in an age appropriate form.
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 or inhalant allergen immunotherapy or other systemic immunomodulatory treatment;
- Inability to stop anti-histamines prior to SPT or OFC.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United Kingdom11 sites, 11 recruiting
- Recruiting
Sandwell and West Birmingham Hospital
Birmingham
- Not yet recruiting
Addenbrookes Hospital
Cambridge
- Not yet recruiting
Royal Hospital for Children and Young People
Edinburgh
- Recruiting
Leicester Royal Infirmary
Leicester
- Recruiting
Evelina London Children's Hospital
London
Professor Alexandra Santos
- Not yet recruiting
King's College Hospital
London
- Not yet recruiting
University College London Hospital
London
- Not yet recruiting
Royal Manchester Children's Hospital
Manchester
- Not yet recruiting
Great North Children's Hospital
Newcastle
- Not yet recruiting
Sheffield Children's Hospital
Sheffield
- Recruiting
University Hospital Southampton
Southampton
About this study
Official title: Randomised Controlled Multicentre Trial on the Clinical Impact of the Basophil Activation Test and the Mast Cell Activation Test as Food Allergy Biomarkers in Children and Young People
The BAT Impact study is a prospective multicentre study in the UK using a biomarker-led study design to compare the incidence of adverse events (defined as allergic reactions during oral food challenges) in a randomized-controlled trial. Patients will either follow the standard-of-care (i.e. an oral food challenge in case of equivocal SPT/sIgE) or follow a basophil activation test (BAT)/mast cell activation test (MAT)-based strategy, i.e. patients with a positive BAT or MAT are dispensed of an oral food challenge (OFC) and patients with a negative BAT/MAT undergo an OFC.
Read the detailed description
Children aged 6 months to 15 years requiring an oral food challenge to one of the study foods (milk, egg, peanut, sesame or cashew nut) will be invited to participate in the study.
Eleven centres across the UK will be recruiting participants and perforning clinical procedures, such as skin prick testing and oral food challenges (OFC), as per standard clinical care.
Participants will be randomised 4:5 to either have the standard-of-care, i.e. oral food challenge to the suspected food, or take BAT (MAT if BAT inconclusive) into account to decide whether or not OFC will be required: if BAT/MAT is positive, food allergy will be confirmed without doing OFC; if BAT/MAT is negative, participants in the biomarker arm will undergo OFC.
The primary outcome is the proportion of positive OFC in the biomarker arm compared with the standard-of-care arm.
Secondary outcomes are: number of OFC, quality of life, anxiety and costs associated with the diagnostic work-up.
- Conditions
- Food Allergy, Food Allergy in Infants, Food Allergy in Children, Food Allergen Sensitisation, Milk Allergy, Egg Allergy
- Being tested
- Basophil activation test (BAT), Oral food challenge (OFC)
- Keywords
- Food allergy, Milk allergy, Egg allergy, Nut allergy, Basophil activation test, Mast cell activation test, Diagnosis, Specific IgE, Skin prick test, Oral food challenge
- 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.
Basophil activation test (BAT)Diagnostic test
Also called Mast cell activation test (MAT)
Basophils and mast cells are the key drivers of food allergic reactions and anaphylaxis to foods. The study team have developed new tests that measure the reaction of mast cells and basophils by flow cytometry following stimulation with allergen, the BAT and the MAT:
- BAT uses fresh whole blood from patients added to allergen and antibodies in a test tube. The tube containing the allergic cells are then analysed one by one to estimate how many and how much express activation markers on their surface, CD63 and CD203c.
MAT uses a human mast cell line (LAD2 cells) which are human mast cells grown in the laboratory to which patients' plasma is added in order to mimic the patients' own mast cells. Sensitised LAD2 cells are then stimulated with allergen or controls and analysed by flow cytometry to assess the expression of the activation marker CD63 on the cell surface, similar to what happens in the BAT. Results of MAT will be considered only in cases of non-responding basophils.
Oral food challenge (OFC)Diagnostic test
Consumption of the food suspected of causing an allergic reaction in a medically supervised environment, starting with small amounts and progressively increasing the dose at regular intervals up to a cumulative dose corresponding to an age-appropriate portion of the food.
| Study group | Role | What they receive |
|---|---|---|
| Biomarker arm | Experimental | All participants will have blood taken to test for BAT/MAT. Participants with a positive BAT/MAT will dispense from oral food challenge (OFC).
Participants with negative or inconclusive BAT/MAT will undergo OFC. Receives: Diagnostic Test: Basophil activation test (BAT); Diagnostic Test: Oral food challenge (OFC) |
| Standard-of-care arm | Active comparator | All participants in the standard-of-care arm will have blood taken to test for BAT/MAT. Regardless of the result of BAT/MAT, all participants in this arm will undergo an oral food challenge, as per the current standard-of-care. Receives: Diagnostic Test: Basophil activation test (BAT); Diagnostic Test: Oral food challenge (OFC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of positive oral food challenges in the biomarker arm (BAT ± MAT) compared to the standard-of-care arm
Comparison of the ratio of positive oral food challenges in the biomarker arm compared to the standard-of-care arm.
Measured: Up to 1 year
Number of OFCs in the biomarker arm (BAT ± MAT) compared to the standard-of-care arm
Comparison of the ratio of OFCs in the biomarker arm compared to the standard-of-care arm.
Measured: Up to 1 year
Secondary outcomes (4)
The quality of life of children and parents at the start and at the end of the diagnostic work-up for food allergy as assessed by the Food Allergy Quality of Life Questionnaire.
Change in quality of life score at the start and end of diagnostic work-up.
Measured: Up to 1.5 years
Anxiety levels of parents and children before and after diagnostic work-up as assessed by the Hospital Anxiety and Depression Questionnaire.
Change in anxiety score before and after diagnostic work-up.
Measured: Up to 1.5 years
Anxiety levels of parents and children before and after diagnostic work-up as assessed by the State Trait Anxiety Inventory.
Change in anxiety score before and after diagnostic work-up.
Measured: Up to 1.5 years
NHS and societal costs of food allergies during the diagnostic assessment, as measured through a bespoke form.
NHS and societal costs during the six weeks before and six weeks after diagnostic work-up.
Measured: Up to 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2022
- Study start13 Jan 2023
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (estimated)
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.
- More trials run by King's College LondonThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomised using a 4:5 allocation between standard-of-care/biomarker arms. Stratified randomisation will be adopted according to recruiting centre, using a web-based allocation system.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 398 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- Sandwell & West Birmingham Hospitals NHS Trust, Cambridge University Hospitals NHS Foundation Trust, NHS Lothian, University Hospitals, Leicester, Guy's and St Thomas' NHS Foundation Trust, University College London Hospitals, King's College Hospital NHS Trust, Manchester University NHS Foundation Trust, Newcastle-upon-Tyne Hospitals NHS Trust, Sheffield Children's NHS Foundation Trust, University Hospital Southampton NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Alexandra Santos, MD, PhD, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05309772
- Sponsor's protocol ID
- IRAS 299511
- Status last verified
- Mar 2023
- First submitted
- 7 Sep 2021
- Last updated
- 6 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Multicentre Trial on the Clinical Impact of the Basophil Activation Test and the Mast Cell Activation Test as Food Allergy Biomarkers in Children and Young People
- ClinicalTrials.gov ID
- NCT05309772
- Acronym / sponsor ID
- IRAS 299511
- 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, Mast cell activation test, Diagnosis, Specific IgE
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 398 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- Sandwell & West Birmingham Hospitals NHS Trust, Cambridge University Hospitals NHS Foundation Trust, NHS Lothian, University Hospitals, Leicester, Guy's and St Thomas' NHS Foundation Trust, University College London Hospitals, King's College Hospital NHS Trust, Manchester University NHS Foundation Trust, Newcastle-upon-Tyne Hospitals NHS Trust, Sheffield Children's NHS Foundation Trust, University Hospital Southampton NHS Foundation Trust
- Study start
- 13 Jan 2023 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 4 Apr 2022 (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 Impact study is a prospective multicentre study in the UK using a biomarker-led study design to compare the incidence of adverse events (defined as allergic reactions during oral food challenges) in a randomized-controlled trial. Patients will either follow the standard-of-care (i.e. an oral food challenge in case of equivocal SPT/sIgE) or follow a basophil activation test (BAT)/mast cell activation test (MAT)-based strategy, i.e. patients with a positive BAT or MAT are dispensed of an oral food challenge (OFC) and patients with a negative BAT/MAT undergo an OFC.
Detailed description
Children aged 6 months to 15 years requiring an oral food challenge to one of the study foods (milk, egg, peanut, sesame or cashew nut) will be invited to participate in the study.
Eleven centres across the UK will be recruiting participants and perforning clinical procedures, such as skin prick testing and oral food challenges (OFC), as per standard clinical care.
Participants will be randomised 4:5 to either have the standard-of-care, i.e. oral food challenge to the suspected food, or take BAT (MAT if BAT inconclusive) into account to decide whether or not OFC will be required: if BAT/MAT is positive, food allergy will be confirmed without doing OFC; if BAT/MAT is negative, participants in the biomarker arm will undergo OFC.
The primary outcome is the proportion of positive OFC in the biomarker arm compared with the standard-of-care arm.
Secondary outcomes are: number of OFC, quality of life, anxiety and costs associated with the diagnostic work-up.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Patients will be randomised using a 4:5 allocation between standard-of-care/biomarker arms. Stratified randomisation will be adopted according to recruiting centre, using a web-based allocation system.
| Arm | Type | Receives |
|---|---|---|
| Biomarker arm | Experimental | Diagnostic Test: Basophil activation test (BAT), Diagnostic Test: Oral food challenge (OFC)All participants will have blood taken to test for BAT/MAT. Participants with a positive BAT/MAT will dispense from oral food challenge (OFC). Participants with negative or inconclusive BAT/MAT will undergo OFC. |
| Standard-of-care arm | Active comparator | Diagnostic Test: Basophil activation test (BAT), Diagnostic Test: Oral food challenge (OFC)All participants in the standard-of-care arm will have blood taken to test for BAT/MAT. Regardless of the result of BAT/MAT, all participants in this arm will undergo an oral food challenge, as per the current standard-of-care. |
Who may qualify
- Ages
- 6 months to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Children and young people aged 6 months to 15 years
- Suspected allergy to one of the study foods (peanut, cow's milk, egg, cashew, sesame) - defined as:
- Need for an oral food challengeOFC to the study food
- Oral food challengeOFC to reach amount of food protein in a typical portion size for child's age
- Consent from adults with parental responsibility and assent from children and young people in an age appropriate form.
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 or inhalant 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 |
|---|---|---|
| Basophil activation test (BAT)Also: Mast cell activation test (MAT)Basophils and mast cells are the key drivers of food allergic reactions and anaphylaxis to foods. The study team have developed new tests that measure the reaction of mast cells and basophils by flow cytometry following stimulation with allergen, the BAT and the MAT: • BAT uses fresh whole blood from patients added to allergen and antibodies in a test tube. The tube containing the allergic cells are then analysed one by one to estimate how many and how much express activation markers on their surface, CD63 and CD203c. MAT uses a human mast cell line (LAD2 cells) which are human mast cells grown in the laboratory to which patients' plasma is added in order to mimic the patients' own mast cells. Sensitised LAD2 cells are then stimulated with allergen or controls and analysed by flow cytometry to assess the expression of the activation marker CD63 on the cell surface, similar to what happens in the BAT. Results of MAT will be considered only in cases of non-responding basophils. | Diagnostic test | Biomarker arm, Standard-of-care arm |
| Oral food challenge (OFC)Consumption of the food suspected of causing an allergic reaction in a medically supervised environment, starting with small amounts and progressively increasing the dose at regular intervals up to a cumulative dose corresponding to an age-appropriate portion of the food. | Diagnostic test | Biomarker arm, Standard-of-care arm |
Primary outcome
The proportion of positive oral food challenges in the biomarker arm (BAT ± MAT) compared to the standard-of-care arm
Time frame: Up to 1 year
Comparison of the ratio of positive oral food challenges in the biomarker arm compared to the standard-of-care arm.
Number of OFCs in the biomarker arm (BAT ± MAT) compared to the standard-of-care arm
Time frame: Up to 1 year
Comparison of the ratio of OFCs in the biomarker arm compared to the standard-of-care arm.
4 secondary outcomes
The quality of life of children and parents at the start and at the end of the diagnostic work-up for food allergy as assessed by the Food Allergy Quality of Life Questionnaire.
Time frame: Up to 1.5 years
Anxiety levels of parents and children before and after diagnostic work-up as assessed by the Hospital Anxiety and Depression Questionnaire.
Time frame: Up to 1.5 years
Anxiety levels of parents and children before and after diagnostic work-up as assessed by the State Trait Anxiety Inventory.
Time frame: Up to 1.5 years
NHS and societal costs of food allergies during the diagnostic assessment, as measured through a bespoke form.
Time frame: Up to 1.5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
- Individual participant dataSharing planned: No
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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
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Basophil activation test (BAT) and Oral food challenge (OFC) in people with Food Allergy and Food Allergy in Infants, run by King's College London at 11 sites 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 8 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 6 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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 (+44 (0) 20 7188 6424, 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?
The proportion of positive oral food challenges in the biomarker arm (BAT ± MAT) compared to the standard-of-care arm (time frame: Up to 1 year). The study lists 2 primary outcomes in all. 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 6 Sep 2023.