Improved Diagnostics in Food Allergy Study

Not Applicable

• Conditions: Food Allergy
• Interventions: Diagnostic Test: Intranasal food challenge; Diagnostic Test: Mast cell activation test

• Registration Number: NCT06097572
• Lead Sponsor: Imperial College London

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-18
• Study First Submitted: 2023-10-18
• Study First Submitted QC: 2023-10-18
• Study First Posted: 2023-10-24
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-27
• Last Update Posted: 2024-03-28
• Primary Completion: 2025-07-31
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 166

Inclusion Criteria

• IgE-sensitisation to peanut, (hen's) egg or cow's milk, with indeterminate clinical (allergy) status, defined as IgE-sensitisation below 95% positive predictive value (PPV) for diagnosis for either allergen-specific IgE or SPT, using published cut-offs OR clinician suspicion of tolerance (on basis of clinical history) despite IgE sensitisation >95% PPV cut-offs.
• Written informed consent from parent/guardian, with assent from children aged 6 years and above wherever possible. Participants aged over 16 years will need to provide their own informed consent.

Exclusion Criteria

• Acute illness or current unstable asthma, defined as:

  1. Febrile ≥38.0oC in last 72 hours
  2. Acute wheeze in last 72 hours requiring treatment
  3. Recent admission to hospital in preceding 2 weeks for acute asthma

• Current medication

  1. Asthma reliever medication required in preceding 72 hours
  2. Recent administration of a medicine containing antihistamine within the last 3 days
  3. Current oral steroid for asthma exacerbation or course completed within last 2 weeks

• Unwilling or unable to fulfil study requirements

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Peanut	Intranasal food challenge	Participants with possible allergy to peanut
Cow's Milk	Intranasal food challenge	Participants with possible allergy to cow's milk
Peanut	Mast cell activation test	Participants with possible allergy to peanut
Cow's Milk	Mast cell activation test	Participants with possible allergy to cow's milk

Primary Outcome Measures

Name	Time	Method
Test performance	1 day	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)

Secondary Outcome Measures

Name	Time	Method
Adverse events	1 day	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.

Trial Locations

Locations (2)

Imperial College Healthcare NHS Trust (St. Mary's Hospital); 🇬🇧 London, United Kingdom

Prof Jonathan Hourihane; 🇮🇪 Dublin, Ireland