The ID-in-FA Study
Research type
Research Study
Full title
Improved diagnostics in food allergy (ID-in-FA) Study
IRAS ID
282818
Contact name
Paul Turner
Contact email
Sponsor organisation
Imperial College London-Research Governance and Integrity Team (RGIT)
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 11 months, 30 days
Research summary
Food allergy affects up to 6% of UK children. Management involves dietary elimination which impairs quality of life and results in significant anxiety on the part of both the family, those charged with the child’s care (e.g. school staff) and the child. The gold-standard for diagnosis is the oral food challenge, where a child eats increasing doses of the allergen in question under medical supervision. These are costly, time-consuming and not without risk, due to the potential for inducing systemic allergic reactions. Safer and less burdensome food allergy diagnostics, which can be performed in the outpatient setting, are thus an important goal.
In this project, we will assess the ability of 2 novel, complementary tests to accurately diagnose food allergy. We will recruit children and young people with indeterminate allergic status despite conventional allergy testing, who have been recruited from our specialist allergy clinic and are due to undergo formal food challenge to clarify a diagnosis of food allergy to peanut, egg or cow's milk. In addition to undertaking conventional allergy tests immediately prior to the food challenge, we will perform:
1. Mast cell activation test (MAT) - in which mast cells (generated from precursor cells in donated blood) are incubated with a small amount of blood from the patient and then exposed to the food allergen, and the mast cell response measured.
2. Intranasal food challenge (InFC) - a quick and straightforward procedure in which very small amounts of food protein are administered into the nose, causing a mild hay fever-like response in allergic, but not non-allergic individuals.
We will assess how these tests compare to conventional allergy testing, to determine the best strategy to accurately diagnose food allergy without the need for formal food challenge.REC name
North West - Greater Manchester West Research Ethics Committee
REC reference
22/NW/0321
Date of REC Opinion
18 Nov 2022
REC opinion
Further Information Favourable Opinion