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| ID | Type | Description | Link |
|---|---|---|---|
| 22/NW/0321 | Other Identifier | NHS Human Research Authority |
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| Name | Class |
|---|---|
| Royal College of Surgeons, Ireland | OTHER |
| University of Manchester | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peanut | Experimental | Participants with possible allergy to peanut |
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| Cow's Milk | Experimental | Participants with possible allergy to cow's milk |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intranasal food challenge | Diagnostic Test | Subjects will undergo an incremental intranasal challenge to initially 0.9% NaCl saline solution, and then increasing doses of the food protein |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
Acute illness or current unstable asthma, defined as:
Current medication
Unwilling or unable to fulfil study requirements
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prof Jonathan Hourihane | Dublin | Ireland | ||||
| Imperial College Healthcare NHS Trust (St. Mary's Hospital) |
Anonymised data may be shared upon request to the Chief Investigator.
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| ID | Term |
|---|---|
| D005512 | Food Hypersensitivity |
| ID | Term |
|---|---|
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| Mast cell activation test | Diagnostic Test | Blood will be processed for mast cell activation as previously described (https://doi.org/10.1016/j.jaci.2018.01.043) |
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| London |
| United Kingdom |