- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05309772
The Clinical Impact of the Basophil Activation Test to Diagnose Food Allergy
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Alexandra Santos, MD, PhD
- Phone Number: +44 (0) 20 7188 6424
- Email: alexandra.santos@kcl.ac.uk
Study Locations
-
-
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Birmingham, United Kingdom
- Recruiting
- Sandwell and West Birmingham Hospital
-
Cambridge, United Kingdom
- Not yet recruiting
- Addenbrookes Hospital
-
Edinburgh, United Kingdom
- Not yet recruiting
- Royal Hospital for Children and Young People
-
Leicester, United Kingdom
- Recruiting
- Leicester Royal Infirmary
-
London, United Kingdom
- Not yet recruiting
- King's College Hospital
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London, United Kingdom
- Not yet recruiting
- University College London Hospital
-
London, United Kingdom
- Recruiting
- Evelina London Children's Hospital
-
Contact:
- Professor Alexandra Santos
-
Manchester, United Kingdom
- Not yet recruiting
- Royal Manchester Children's Hospital
-
Newcastle, United Kingdom
- Not yet recruiting
- Great North Children's Hospital
-
Sheffield, United Kingdom
- Not yet recruiting
- Sheffield Children's Hospital
-
Southampton, United Kingdom
- Recruiting
- University Hospital Southampton
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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);
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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. |
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.
Other Names:
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.
|
Active Comparator: 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.
|
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.
Other Names:
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Up to 1 year
|
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.
|
Up to 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Change in quality of life score at the start and end of diagnostic work-up.
|
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
|
Change in anxiety score before and after diagnostic work-up.
|
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
|
Change in anxiety score before and after diagnostic work-up.
|
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
|
NHS and societal costs during the six weeks before and six weeks after diagnostic work-up.
|
Up to 1.5 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Alexandra Santos, MD, PhD, King's College London
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRAS 299511
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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