Improved Diagnostics in Food Allergy Study

NCT ID: NCT06097572

Last Updated: 2024-03-28

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 166 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-18
• Study Completion Date: 2025-07-31

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.

Conditions

Food Allergy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Peanut

Participants with possible allergy to peanut

Group Type: EXPERIMENTAL

Intranasal food challenge

Intervention Type: DIAGNOSTIC_TEST

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

Intervention Type: DIAGNOSTIC_TEST

Blood will be processed for mast cell activation as previously described (https://doi.org/10.1016/j.jaci.2018.01.043)

Cow's Milk

Participants with possible allergy to cow's milk

Group Type: EXPERIMENTAL

Intranasal food challenge

Intervention Type: DIAGNOSTIC_TEST

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

Intervention Type: DIAGNOSTIC_TEST

Blood will be processed for mast cell activation as previously described (https://doi.org/10.1016/j.jaci.2018.01.043)

Interventions

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

Intervention Type: 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)

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Royal College of Surgeons, Ireland

OTHER

Sponsor Role: collaborator

University of Manchester

OTHER

Sponsor Role: collaborator

Imperial College London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Prof Jonathan Hourihane

Dublin, , Ireland

Imperial College Healthcare NHS Trust (St. Mary's Hospital)

London, , United Kingdom

Countries

Ireland; United Kingdom

Other Identifiers

22/NW/0321

Identifier Type: OTHER

Identifier Source: secondary_id

22SM7832

Identifier Type: -

Identifier Source: org_study_id