NCT06097572

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.

Trial Health

58
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
166

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2023

Typical duration for not_applicable

Geographic Reach
2 countries

2 active sites

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 18, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

October 18, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 24, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
Last Updated

March 28, 2024

Status Verified

March 1, 2024

Enrollment Period

1.8 years

First QC Date

October 18, 2023

Last Update Submit

March 27, 2024

Conditions

Food Allergy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Adverse events

    1 day

Study Arms (2)

Peanut

EXPERIMENTAL

Participants with possible allergy to peanut

Diagnostic Test: Intranasal food challengeDiagnostic Test: Mast cell activation test

Cow's Milk

EXPERIMENTAL

Participants with possible allergy to cow's milk

Diagnostic Test: Intranasal food challengeDiagnostic Test: Mast cell activation test

Interventions

Intranasal food challengeDIAGNOSTIC_TEST

Subjects will undergo an incremental intranasal challenge to initially 0.9% NaCl saline solution, and then increasing doses of the food protein

Cow's MilkPeanut
Mast cell activation testDIAGNOSTIC_TEST

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

Cow's MilkPeanut

Eligibility Criteria

Age2 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Prof Jonathan Hourihane

Dublin, Ireland

Location

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

London, United Kingdom

Location

MeSH Terms

Conditions

Food Hypersensitivity

Condition Hierarchy (Ancestors)

Hypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2023

First Posted

October 24, 2023

Study Start

October 18, 2023

Primary Completion

July 31, 2025

Study Completion

July 31, 2025

Last Updated

March 28, 2024

Record last verified: 2024-03

Locations

IE(1)GB(1)