NCT06097572

Improved Diagnostics in Food Allergy Study

Improved Diagnostics in Food Allergy (ID-in-FA) Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 166 (estimated)
• Sponsor: Imperial College London · Academic / Other
• Sex: All
• Age: 2 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Food Allergy

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Intranasal food challenge	Subjects will undergo an incremental intranasal challenge to initially 0.9% NaCl saline solution, and then increasing doses of the food protein
DIAGNOSTIC_TEST	Mast cell activation test	Blood will be processed for mast cell activation as previously described (https://doi.org/10.1016/j.jaci.2018.01.043)

Timeline

• Start date: 2023-10-18
• Primary completion: 2025-07-31
• Completion: 2025-07-31
• First posted: 2023-10-24
• Last updated: 2024-03-28

Locations

2 sites across 2 countries: Ireland, United Kingdom