Clinical Trials

Basophil Activation Test to Diagnose Food Allergy

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	6 Months - 16 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Children ≥6 months and <16 years old; 2. 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); 3.

Avoidance of the specific food for at least 2 days prior to blood collection for BAT and specific IgE and prior to the challenge; 4. Informed consent obtained from parent or guardian and assent obtained from the child.

Exclusion Criteria:

1. Clinically significant chronic illness other than atopic diseases; 2. 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; 3. Unwillingness to comply with study procedures, namely to undergo a diagnostic food challenge; 4. 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; 5.

Undergoing treatment with omalizumab, food allergen immunotherapy or other systemic immunomodulatory treatment; 6. Inability to stop anti-histamines prior to SPT.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03309488
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	King's College London
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Alexandra Santos, MD PhD
Principal Investigator Affiliation	King's College London
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United Kingdom
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Food Allergy, Food Allergy in Infants, Food Allergy in Children, Food Allergen Sensitisation, Milk Allergy, Egg Allergy, Nut Allergy

Arms & Interventions

Arms

: Food allergic

Patients with a positive oral challenge to the food being studied.

: Non food allergic

Patients with a negative oral challenge to the food being studied.

Interventions

Diagnostic Test: - Oral food challenge

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

London, United Kingdom

Status

Recruiting

Address

Pediatric Allergy Clinical Research Facility, Evelina Children's Hospital

London, , SE17EH

Site Contact

Monica Basting

monica.basting@kcl.ac.uk

+442071886424

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