An interventional study of Intranasal food challenge and Mast cell activation test in Food Allergy, sponsored by Imperial College London. Enrolling by invitation at 2 sites in 2 countries. Open to participants aged 2 Years to 18 Years. Per ClinicalTrials.gov, last updated 2024-03-28.
Sponsored by Imperial College London · Not applicable, Interventional, and Diagnostic
The investigators will conduct low-dose intranasal allergen challenges on children and young people with an indeterminate diagnosis of food allergy to cow's milk or peanut. Blood samples will also be taken, for conventional blood allergy diagnostics (allergy-specific Immunoglobulin E) and mast cell activation test (MAT). The data will be used to determine the diagnostic accuracy of two complementary, novel approaches to diagnose food allergy, in a representative clinical cohort.
1,916 studies on the registry are indexed under Hypersensitivity; 265 are open to participants now.
This study's planned enrollment of 166 is above the median of 57 across 1,384 interventional studies indexed under Hypersensitivity.
Browse Hypersensitivity studies →Imperial College London is the lead sponsor of 824 studies on the registry; 178 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
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Exclusion Criteria:
Acute illness or current unstable asthma, defined as:
Current medication
Participants with possible allergy to peanut
Diagnostic Test: Intranasal food challenge · Diagnostic Test: Mast cell activation test
Participants with possible allergy to cow's milk
Diagnostic Test: Intranasal food challenge · Diagnostic Test: Mast cell activation test
Subjects will undergo an incremental intranasal challenge to initially 0.9% NaCl saline solution, and then increasing doses of the food protein
Blood will be processed for mast cell activation as previously described (https://doi.org/10.1016/j.jaci.2018.01.043)
Test performance
Comparison of test performance characteristics (sensitivity, specificity, measured according to standard statistical methods) for each of the following diagnostic tests, compared to a formal oral food challenge (FC) as the reference standard: i. Intranasal FC (InFC) ii. Skin prick testing iii. Characterisation of serum-specific IgE to whole allergen, components and molecular components iv. Mast cell activation test (MAT) v. Basophil activation test (BAT) (peanut only)
Time frame: 1 day
Adverse events
Number of participants who experience a non-allergic adverse event, and/or have symptoms of a systemic allergic reaction) associated with the intranasal food challenge.
Time frame: 1 day
Plan to share: Undecided — Anonymised data may be shared upon request to the Chief Investigator.
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Imperial College London