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Trial record 19 of 62 for:    Recruiting, Not yet recruiting, Available Studies | "Food Hypersensitivity"

Basophil Activation Test to Diagnose Food Allergy (BAT2)

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ClinicalTrials.gov Identifier: NCT03309488
Recruitment Status : Recruiting
First Posted : October 13, 2017
Last Update Posted : May 9, 2018
Sponsor:
Collaborator:
Guy's and St Thomas' NHS Foundation Trust
Information provided by (Responsible Party):
King's College London

Brief 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.

Condition or disease Intervention/treatment
Food Allergy Food Allergy in Infants Food Allergy in Children Food Allergen Sensitisation Milk Allergy Egg Allergy Nut Allergy Diagnostic Test: Oral food challenge

Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Basophil Activation Test to Diagnose Food Allergy
Actual Study Start Date : January 30, 2018
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Food allergic
Patients with a positive oral challenge to the food being studied.
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.
Other Names:
  • Basophil activation test
  • Skin prick test
  • Specific IgE test

Non food allergic
Patients with a negative oral challenge to the food being studied.
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.
Other Names:
  • Basophil activation test
  • Skin prick test
  • Specific IgE test




Primary Outcome Measures :
  1. Diagnostic accuracy of the basophil activation test (for each individual food allergy) [ Time Frame: 3 years ]
    Accuracy of %CD63+ basophils


Secondary Outcome Measures :
  1. Diagnostic accuracy of SPT, specific IgE to extracts and to single allergens [ Time Frame: 3 years ]
    Accuracy of weal diameter or level of IgE

  2. Association between BAT and severity of symptoms during challenges [ Time Frame: 3 years ]
    Correlation between %CD63+ basophils and severity grade

  3. Association between BAT and threshold of reactivity during challenges [ Time Frame: 3 years ]
    Correlation between CD-sens and cumulative threshold dose



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 16 Years   (Child)
Sexes Eligible for Study:   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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03309488


Contacts
Contact: Alexandra Santos, MD PhD +442071886424 alexandra.santos@kcl.ac.uk
Contact: Monica Basting +442071881956 monica.basting@kcl.ac.uk

Locations
United Kingdom
Pediatric Allergy Clinical Research Facility, Evelina Children's Hospital Recruiting
London, United Kingdom, SE17EH
Contact: Monica Basting       monica.basting@kcl.ac.uk   
Principal Investigator: Alexandra Santos, MD PhD         
Sponsors and Collaborators
King's College London
Guy's and St Thomas' NHS Foundation Trust
Investigators
Principal Investigator: Alexandra Santos, MD PhD King's College London

Responsible Party: King's College London
ClinicalTrials.gov Identifier: NCT03309488     History of Changes
Other Study ID Numbers: IRAS 197886
First Posted: October 13, 2017    Key Record Dates
Last Update Posted: May 9, 2018
Last Verified: July 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by King's College London:
Food allergy
Milk allergy
Egg allergy
Nut allergy
Basophil activation test
Diagnosis
Specific IgE
Skin prick test

Additional relevant MeSH terms:
Hypersensitivity
Food Hypersensitivity
Milk Hypersensitivity
Egg Hypersensitivity
Nut Hypersensitivity
Immune System Diseases
Hypersensitivity, Immediate