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Improved Diagnostics in Food Allergy Study

NCT06097572 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 166

Last updated 2024-03-28

No results posted yet for this study

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

Interventions

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

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)

Sponsors & Collaborators

  • Royal College of Surgeons, Ireland

    collaborator OTHER

  • University of Manchester

    collaborator OTHER

  • Imperial College London

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-18
Primary Completion
2025-07-31
Completion
2025-07-31

Countries

  • Ireland
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06097572 on ClinicalTrials.gov