Clinical trial NCT05309772: The Clinical Impact of the Basophil Activation Test to Diagnose Food Allergy
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Food Allergy
Food Allergy in Infants
Food Allergy in Children
Food Allergen Sensitisation
Milk Allergy
Egg Allergy
Nut Allergy
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
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: Sandwell & West Birmingham Hospitals NHS Trust
name: Cambridge University Hospitals NHS Foundation Trust
name: NHS Lothian
name: University Hospitals, Leicester
name: Guy's and St Thomas' NHS Foundation Trust
name: University College London Hospitals
name: King's College Hospital NHS Trust
name: Manchester University NHS Foundation Trust
name: Newcastle-upon-Tyne Hospitals NHS Trust
name: Sheffield Children's NHS Foundation Trust
name: University Hospital Southampton NHS Foundation Trust
First posted: 2022-04-04
Enrollment: 398
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: DIAGNOSTIC

Brief 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. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The proportion of positive oral food challenges in the biomarker arm (BAT ± MAT) compared to the standard-of-care arm
timeFrame: Up to 1 year
measure: Number of OFCs in the biomarker arm (BAT ± MAT) compared to the standard-of-care arm
timeFrame: Up to 1 year
Secondary outcomes:
measure: 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.
timeFrame: Up to 1.5 years
measure: Anxiety levels of parents and children before and after diagnostic work-up as assessed by the Hospital Anxiety and Depression Questionnaire.
timeFrame: Up to 1.5 years
measure: Anxiety levels of parents and children before and after diagnostic work-up as assessed by the State Trait Anxiety Inventory.
timeFrame: Up to 1.5 years
measure: NHS and societal costs of food allergies during the diagnostic assessment, as measured through a bespoke form.
timeFrame: Up to 1.5 years
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: Sandwell and West Birmingham Hospital
city: Cambridge
country: United Kingdom
facility: Addenbrookes Hospital
city: Edinburgh
country: United Kingdom
facility: Royal Hospital for Children and Young People
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary
city: London
country: United Kingdom
facility: Evelina London Children's Hospital
city: London
country: United Kingdom
facility: King's College Hospital
city: London
country: United Kingdom
facility: University College London Hospital
city: Manchester
country: United Kingdom
facility: Royal Manchester Children's Hospital
city: Newcastle
country: United Kingdom
facility: Great North Children's Hospital
city: Sheffield
country: United Kingdom
facility: Sheffield Children's Hospital
city: Southampton
country: United Kingdom
facility: University Hospital Southampton
Study officials:
affiliation: King's College London
name: Alexandra Santos, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: