Luminex-based Assay to Identify Major IgE-binding Episode Among IgE-mediated Wheat-allergic Patient

Mahidol University

Status: Completed

Conditions: Wheat Allergy

Treatments: Procedure: Blood drawing

Study type: Observational

Funder types: Other

Identifiers

NCT04100122

359/2562(EC3)

Details and patient eligibility

About

This study will be using Luminex-based peptide assay (LPA) to determine major IgE-binding epitope among wheat allergic children to differentiate clinical phenotype.

Full description

Luminex-based peptide assay (LPA) is a novel tool using machine learning techniques, developed to predict different degrees of food allergy has been successfully reported among cow's milk protein allergy. This technique provide a more precise and advanced adaptation from microarray-based immunoassay (MIA). Using this technique will aid us for the differentiation of clinical phenotypes of wheat-allergic patients. This study will be the first study to date using this technique aim to determine major IgE-binding epitope among immediated-reaction of wheat allergic children to differentiate clinical phenotypes, and may lead to further study to develop the new therapeutic approach to wheat-allergic patients.

Enrollment: 100 patients

Sex: All

Ages: 1 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

1. Patients with IgE-mediated wheat allergy, with one of the following criteria; 1.1 a convincing clinical history of the reactions within 4 hours after wheat ingestion during the past 12 months combined with positive skin prick test (SPT) and/or the level of specific IgE (sIgE) to wheat or 1.2 a positive oral food challenge (OFC) result to wheat during the past 12 months OR
2. Patients with wheat tolerant confirmed by negative oral food challenge (OFC) result to wheat during the past 12 months OR
3. Patients with IgE-mediated wheat allergy and underwent wheat oral immunotherapy for at least 6 months or at the maintenance phase of the treatment

Exclusion criteria Patients with delayed allergic reactions after wheat ingestion greater than 4 hours

Trial design

100 participants in 3 patient groups

Wheat-allergic

Description:

The diagnosis of IgE-mediated wheat allergy was made if they have one of the following criteria 1. a convincing clinical history of the reactions within 4 hours after wheat ingestion during the past 12 months combined with positive skin prick test (SPT) and/or the level of specific IgE (sIgE) to wheat or 2. a positive oral food challenge (OFC) result to wheat during the past 12 months

Treatment:

Procedure: Blood drawing

Wheat tolerant

Description:

Patients with wheat tolerant confirmed by negative oral food challenge (OFC) result to wheat during the past 12 months

Treatment:

Procedure: Blood drawing

Wheat oral immunotherapy

Description:

Patients with IgE-mediated wheat allergy and underwent wheat oral immunotherapy for at least 6 months or at the maintenance phase of the treatment

Treatment:

Procedure: Blood drawing