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

NCT04100122 | Completed

• 1 other identifier: 359/2562(EC3)
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Wheat Allergy

Keywords

Major allergen

Outcome Measures

Primary Outcomes (1)

• Major Immunoglobulin (Ig) E-binding epitope on wheat proteins and serum/plasma of patients

  For Luminex data, the binding intensity of antibody to epitope specific beads was calculated from the florescence signal of each bead. An index score of binding intensity was generated from the log2 transformation of the signal-to-background ratio and each peptide element, which was close to a normal distribution. A plate effect was observed and adjusted for using linear models. Antibody binding intensities (Luminex) from different groups were compared. To assess the changes in epitope-binding profiles, a linear model was used with group as a factor. Comparisons of interests were tested using t tests and resultant P-values were adjusted for multiple hypotheses using the Benjamini-Hochberg approach, which controls the false discovery rate (FDR) across epitopes. Epitopes were defined as differentially binding epitopes (DBE) if the FDR \< 0.05 and fold changes (FCH) \> 1.5.

  48 months

Secondary Outcomes (1)

• Predict different severity of wheat hypersensitivity reaction

  48 months

Study Arms (3)

Wheat-allergic

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

Procedure: Blood drawing

Wheat tolerant

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

Procedure: Blood drawing

Wheat oral immunotherapy

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

Procedure: Blood drawing

Interventions

Blood drawing PROCEDURE

Blood drawn will be done once using 15 mL of blood volume (Serum or plasma samples will be collected during the routine follow up of level of sIgE to wheat or during the oral food challenge test which intravenous insertion routinely prepared in case of the emergency reaction occurred). The specimen will be transferred to the Icahn School of Medicine at Mount Sinai, New York, USA for Laboratory processing (Luminex-based peptide assay)

Wheat oral immunotherapy; Wheat tolerant; Wheat-allergic

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients between the aged of 1-18 years with confirmed IgE-mediated wheat allergy will be enrolled

You may qualify if:

• 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
• Patients with wheat tolerant confirmed by negative oral food challenge (OFC) result to wheat during the past 12 months OR
• Patients with IgE-mediated wheat allergy and underwent wheat oral immunotherapy for at least 6 months or at the maintenance phase of the treatment

Sponsors & Collaborators

• Mahidol University: lead
• Icahn School of Medicine at Mount Sinai: collaborator
• Samitivej Hospital group: collaborator

Study Sites (1)

Siriraj Hospital

Bangkoknoi, Bangkok, 10700, Thailand

Location

Related Publications (1)

• Suarez-Farinas M, Suprun M, Chang HL, Gimenez G, Grishina G, Getts R, Nadeau K, Wood RA, Sampson HA. Predicting development of sustained unresponsiveness to milk oral immunotherapy using epitope-specific antibody binding profiles. J Allergy Clin Immunol. 2019 Mar;143(3):1038-1046. doi: 10.1016/j.jaci.2018.10.028. Epub 2018 Dec 7.

  PMID: 30528770 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood serum or plasma (Blood drawn will be done using 15 cc of blood volume)

MeSH Terms

Conditions

Wheat Hypersensitivity

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• witchaya srisuwatchari, MD

  Mahidol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2019
• First Posted: September 24, 2019
• Study Start: September 13, 2019
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: May 6, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)