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

Primary Purpose

Food Allergy

Status
Enrolling by invitation
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Intranasal food challenge
Mast cell activation test
Sponsored by
Imperial College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Food Allergy

Eligibility Criteria

2 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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: Febrile ≥38.0oC in last 72 hours Acute wheeze in last 72 hours requiring treatment Recent admission to hospital in preceding 2 weeks for acute asthma Current medication Asthma reliever medication required in preceding 72 hours Recent administration of a medicine containing antihistamine within the last 3 days Current oral steroid for asthma exacerbation or course completed within last 2 weeks Unwilling or unable to fulfil study requirements

Sites / Locations

  • Prof Jonathan Hourihane
  • Imperial College Healthcare NHS Trust (St. Mary's Hospital)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Peanut

Cow's Milk

Arm Description

Participants with possible allergy to peanut

Participants with possible allergy to cow's milk

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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.

Full Information

First Posted
October 18, 2023
Last Updated
October 18, 2023
Sponsor
Imperial College London
Collaborators
Royal College of Surgeons, Ireland, University of Manchester
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1. Study Identification

Unique Protocol Identification Number
NCT06097572
Brief Title
Improved Diagnostics in Food Allergy Study
Acronym
ID-in-FA
Official Title
Improved Diagnostics in Food Allergy (ID-in-FA) Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
October 18, 2023 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College London
Collaborators
Royal College of Surgeons, Ireland, University of Manchester

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Food Allergy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
166 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Peanut
Arm Type
Experimental
Arm Description
Participants with possible allergy to peanut
Arm Title
Cow's Milk
Arm Type
Experimental
Arm Description
Participants with possible allergy to cow's milk
Intervention Type
Diagnostic Test
Intervention Name(s)
Intranasal food challenge
Intervention Description
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
Intervention Name(s)
Mast cell activation test
Intervention Description
Blood will be processed for mast cell activation as previously described (https://doi.org/10.1016/j.jaci.2018.01.043)
Primary Outcome Measure Information:
Title
Test performance
Description
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)
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Adverse events
Description
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.
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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: Febrile ≥38.0oC in last 72 hours Acute wheeze in last 72 hours requiring treatment Recent admission to hospital in preceding 2 weeks for acute asthma Current medication Asthma reliever medication required in preceding 72 hours Recent administration of a medicine containing antihistamine within the last 3 days Current oral steroid for asthma exacerbation or course completed within last 2 weeks Unwilling or unable to fulfil study requirements
Facility Information:
Facility Name
Prof Jonathan Hourihane
City
Dublin
Country
Ireland
Facility Name
Imperial College Healthcare NHS Trust (St. Mary's Hospital)
City
London
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Anonymised data may be shared upon request to the Chief Investigator.

Learn more about this trial

Improved Diagnostics in Food Allergy Study

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