Improved Diagnostics in Food Allergy Study

Food Allergy Clinical Trial

— ID-in-FA  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06097572
• Other study ID #: 22SM7832
• Secondary ID: 22/NW/0321
• Status: Enrolling by invitation
• Phase: N/A
• Start date: October 18, 2023
• Est. completion date: July 31, 2025

Study information

• Verified date: March 2024
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 166
• Est. completion date: July 31, 2025
• Est. primary completion date: July 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Food Allergy
• Food Hypersensitivity
• Hypersensitivity

Intervention

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
• 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)

Locations

Country	Name	City	State
Ireland	Prof Jonathan Hourihane	Dublin
United Kingdom	Imperial College Healthcare NHS Trust (St. Mary's Hospital)	London

Sponsors (3)

Lead Sponsor	Collaborator
Imperial College London	Royal College of Surgeons, Ireland, University of Manchester

Countries where clinical trial is conducted

Ireland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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