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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04100122
Other study ID # 359/2562(EC3)
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 13, 2019
Est. completion date December 31, 2022

Study information

Verified date May 2023
Source Mahidol University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date December 31, 2022
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender All
Age group 1 Year to 18 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Blood drawing
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)

Locations

Country Name City State
Thailand Siriraj Hospital Bangkoknoi Bangkok

Sponsors (3)

Lead Sponsor Collaborator
Mahidol University Icahn School of Medicine at Mount Sinai, Samitivej Hospital group

Country where clinical trial is conducted

Thailand, 

References & 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Predict different severity of wheat hypersensitivity reaction 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
See also
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Completed NCT01070368 - Accuracy Of Skin Prick Test Using In-house Wheat Extract For The Diagnosis Of IgE-mediated Wheat Allergy: A Pilot Study N/A
Terminated NCT04013763 - Outcome of Specific IgE Level in Children With IgE-mediated Wheat Allergy After Stop Using Wheat Containing Skin Care N/A
Recruiting NCT03352193 - Specific Oral Tolerance Induction (SOTI) to Children With IgE-mediated Wheat Allergy
Completed NCT01755884 - Oral Desensitization to Wheat in School Aged Children N/A
Completed NCT03487315 - Major Allergen in Wheat Anaphylaxis in Thai Population N/A