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

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ClinicalTrials.gov Identifier: NCT04100122
Recruitment Status : Enrolling by invitation
First Posted : September 24, 2019
Last Update Posted : March 9, 2021
Sponsor:
Collaborators:
Icahn School of Medicine at Mount Sinai
Samitivej Hospital group
Information provided by (Responsible Party):
Mahidol University

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

Condition or disease Intervention/treatment
Wheat Allergy Procedure: Blood drawing

Detailed 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.

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Luminex-based Assay to Identify Major IgE-binding Episode Among IgE-mediated Wheat-allergic Patient
Actual Study Start Date : September 13, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Group/Cohort Intervention/treatment
Cutaneous only
Cutaneous and mucosal involvement only; generalized hives, pruritus or flushing, swollen lips-tongue-uvula (n=15)
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)

Wheat anaphylaxis sIgElo
Anaphylaxis (using the clinical diagnostic criteria according to World Allergy Organization; WAO 2011) with specific Immunoglobulin E (sIgE) to wheat <100 kUA/L (n=15)
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)

Wheat anaphylaxis sIgEhi
Anaphylaxis (using the clinical diagnostic criteria according to World Allergy Organization; WAO 2011) with specific Immunoglobulin E (sIgE) to wheat ≥100 kUA/L (n=15)
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)

Wheat tolerant
Patients with confirmed IgE-mediated wheat allergy for more than 12 months, and a negative oral food challenge (OFC) result to wheat during the past 12 months will be include as a control group (n=15)
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)




Primary Outcome Measures :
  1. major Immunoglobulin (Ig) E-binding epitope on wheat proteins and serum/plasma of patients [ Time Frame: 24 months ]
    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.


Secondary Outcome Measures :
  1. IgG4-binding epitope on wheat proteins and serum/plasma of patients [ Time Frame: 24 months ]
    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.

  2. predict different severity of wheat hypersensitivity reaction [ Time Frame: 24 months ]
    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.


Biospecimen Retention:   Samples Without DNA
Blood serum or plasma (Blood drawn will be done using 15 cc of blood volume)


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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients between the aged of 1-18 years with confirmed IgE-mediated wheat allergy will be enrolled
Criteria

Inclusion Criteria:

IgE-mediated wheat allergy. 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

Exclusion Criteria:

  • Patients with delayed allergic reactions after wheat ingestion greater than 4 hours or wheat-dependent exercise induced anaphylaxis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04100122


Locations
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Thailand
Siriraj Hospital
Bangkoknoi, Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Icahn School of Medicine at Mount Sinai
Samitivej Hospital group
Investigators
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Principal Investigator: witchaya srisuwatchari, MD Mahidol University
Publications of Results:
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Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT04100122    
Other Study ID Numbers: 359/2562(EC3)
First Posted: September 24, 2019    Key Record Dates
Last Update Posted: March 9, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mahidol University:
Major allergen
Additional relevant MeSH terms:
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Wheat Hypersensitivity
Food Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases