Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03309488
Other study ID # IRAS 197886
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 30, 2018
Est. completion date July 31, 2021

Study information

Verified date September 2020
Source King's College London
Contact Alexandra Santos, MD PhD
Phone +442071886424
Email alexandra.santos@kcl.ac.uk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 600
Est. completion date July 31, 2021
Est. primary completion date July 31, 2021
Accepts healthy volunteers No
Gender All
Age group 6 Months to 16 Years
Eligibility 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, ß-agonists, ß-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.

Study Design


Intervention

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.

Locations

Country Name City State
United Kingdom Pediatric Allergy Clinical Research Facility, Evelina Children's Hospital London

Sponsors (2)

Lead Sponsor Collaborator
King's College London Guy's and St Thomas' NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Diagnostic accuracy of the basophil activation test (for each individual food allergy) Accuracy of %CD63+ basophils 3 years
Secondary Diagnostic accuracy of SPT, specific IgE to extracts and to single allergens Accuracy of weal diameter or level of IgE 3 years
Secondary Association between BAT and severity of symptoms during challenges Correlation between %CD63+ basophils and severity grade 3 years
Secondary Association between BAT and threshold of reactivity during challenges Correlation between CD-sens and cumulative threshold dose 3 years
See also
  Status Clinical Trial Phase
Withdrawn NCT03089476 - Evaluating Skin Barrier Dysfunction in Infants at High Risk of Atopy N/A
Recruiting NCT05839405 - Food Allergy in the Brain
Completed NCT02552537 - iFAAM: The Impact of Proton-pump Inhibitors (Antacids) on Threshold Dose Distributions Phase 4
Completed NCT01634737 - Crustacean Allergy and Dust Mites Sensitization N/A
Recruiting NCT05521711 - TRADE Trial - Tree Nut Immunotherapy Route Development and Evaluation N/A
Completed NCT05072665 - Fast Allergy Sensitivity Test N/A
Active, not recruiting NCT04887441 - Allergology: Information, Data and Knowledge Organization
Recruiting NCT03265262 - The Basophil Activation Test as a Diagnostic Tool in Pediatric Food Allergy N/A
Completed NCT04186949 - Early Origins of Allergy and Asthma
Completed NCT02490007 - Pertussis Immunisation and Food Allergy
Recruiting NCT03151252 - Improvement of Foodallergy Diagnostic in Gastrointestinal Tract N/A
Completed NCT02159833 - Intranasal Diagnostics in Food Allergy: a Feasibility Study N/A
Completed NCT02377284 - Prevention and Management of Food Allergies N/A
Completed NCT02354729 - Encouraging Allergic Young Adults to Carry Epinephrine N/A
Completed NCT02640560 - One-year Survey of Anaphylaxis in Outpatient Children Allergic to Peanuts, Walnuts/Hazelnuts, Shellfish N/A
Enrolling by invitation NCT06097572 - Improved Diagnostics in Food Allergy Study N/A
Recruiting NCT04606615 - Skin Barrier Abnormalities and Oxidative Stress Response
Recruiting NCT05785299 - Clinical Versus Home Introduction of Milk in Children With Non-IgE-mediated Cow's Milk Allergy N/A
Not yet recruiting NCT06112873 - Quality of Life in Food Allergy: Validation of Three Mini-questionnaires
Completed NCT03337802 - Effect of Mediterranean Diet During Pregnancy on the Onset of Overweight and Obesity in the Offspring N/A