The Clinical Impact of the Basophil Activation Test to Diagnose Food Allergy
NCT ID: NCT05309772
Last Updated: 2023-09-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
398 participants
INTERVENTIONAL
2023-01-13
2025-07-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
TRIPLE
Study Groups
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Biomarker arm
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.
Basophil activation test (BAT)
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)
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.
Standard-of-care arm
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.
Basophil activation test (BAT)
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)
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.
Interventions
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Basophil activation test (BAT)
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)
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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);
* 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.
6 Months
15 Years
ALL
No
Sponsors
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Sandwell & West Birmingham Hospitals NHS Trust
OTHER
Cambridge University Hospitals NHS Foundation Trust
OTHER
NHS Lothian
OTHER_GOV
University Hospitals, Leicester
OTHER
Guy's and St Thomas' NHS Foundation Trust
OTHER
University College London Hospitals
OTHER
King's College Hospital NHS Trust
OTHER
Manchester University NHS Foundation Trust
OTHER_GOV
Newcastle-upon-Tyne Hospitals NHS Trust
OTHER
Sheffield Children's NHS Foundation Trust
OTHER
University Hospital Southampton NHS Foundation Trust
OTHER
King's College London
OTHER
Responsible Party
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Principal Investigators
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Alexandra Santos, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
King's College London
Locations
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Sandwell and West Birmingham Hospital
Birmingham, , United Kingdom
Addenbrookes Hospital
Cambridge, , United Kingdom
Royal Hospital for Children and Young People
Edinburgh, , United Kingdom
Leicester Royal Infirmary
Leicester, , United Kingdom
Evelina London Children's Hospital
London, , United Kingdom
King's College Hospital
London, , United Kingdom
University College London Hospital
London, , United Kingdom
Royal Manchester Children's Hospital
Manchester, , United Kingdom
Great North Children's Hospital
Newcastle, , United Kingdom
Sheffield Children's Hospital
Sheffield, , United Kingdom
University Hospital Southampton
Southampton, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Professor Alexandra Santos
Role: primary
Other Identifiers
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IRAS 299511
Identifier Type: -
Identifier Source: org_study_id
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