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Status unknownNCT03309488BAT2Updated Sep 2, 2020

Basophil Activation Test to Diagnose Food Allergy

An observational study in Food Allergy, Food Allergy in Infants and Food Allergy in Children, sponsored by King's College London. Status unknown at 1 site in United Kingdom. Open to participants aged 6 Months to 16 Years. Per ClinicalTrials.gov, last updated 2020-09-02.

Sponsored by King's College London · Observational

The sponsor has not verified this record recently (last verified Sep 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
600
Ages
6 Months to 16 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • 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
  • Diagnosis
  • Specific IgE
  • Skin prick test
03

Who can participate

Ages eligible
6 Months to 16 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Children seen in specialized Pediatric Allergy clinics with suspected allergy to one of the foods studied, namely milk, egg, sesame and nuts.

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

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.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
600 participants (estimated)
Patient registry
No

Groups and cohorts

  • Food allergic

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

    Diagnostic Test: Oral food challenge

  • Non food allergic

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

    Diagnostic Test: Oral food challenge

Interventions

  • Diagnostic testOral 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.

    Also known as: Basophil activation test, Skin prick test, Specific IgE test

05

What researchers measure

Primary outcomes

  1. Diagnostic accuracy of the basophil activation test (for each individual food allergy)

    Accuracy of %CD63+ basophils

    Time frame: 3 years

Secondary outcomes

  1. Diagnostic accuracy of SPT, specific IgE to extracts and to single allergens

    Accuracy of weal diameter or level of IgE

    Time frame: 3 years

  2. Association between BAT and severity of symptoms during challenges

    Correlation between %CD63+ basophils and severity grade

    Time frame: 3 years

  3. Association between BAT and threshold of reactivity during challenges

    Correlation between CD-sens and cumulative threshold dose

    Time frame: 3 years

06

Study locations

1 of 1 sites recruiting
  • Pediatric Allergy Clinical Research Facility, Evelina Children's Hospital
    London, SE17EH, United Kingdom
    Recruiting
07

Registry details

Key details

Study ID
NCT03309488
Lead sponsor
King's College London
Collaborators
Guy's and St Thomas' NHS Foundation Trust
Responsible party
Sponsor
First posted
Oct 13, 2017
Start date
Jan 30, 2018
Primary completion
Jul 31, 2021 (estimated)
Completion
Jul 31, 2021 (estimated)
Last update
Sep 2, 2020

Study contacts

Alexandra Santos, MD PhD
Contact
alexandra.santos@kcl.ac.uk
+442071886424
Georgia Hill
Contact
georgia.hill@gstt.nhs.uk
+442071887188 ext. 51537
Alexandra Santos, MD PhD
principal investigator · King's College London

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

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