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Major Allergen in Wheat Anaphylaxis in Thai Population

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03487315
Recruitment Status : Completed
First Posted : April 4, 2018
Last Update Posted : April 4, 2018
Information provided by (Responsible Party):
Mahidol University

Brief Summary:
  • To study Major allergen in Wheat anaphylaxis in Thai population
  • To study and compare demographic data between group of wheat anaphylaxis

Condition or disease Intervention/treatment Phase
Wheat Allergy Anaphylaxis Food Anaphylaxis Exercise Diagnostic Test: immunoblot Not Applicable

Detailed Description:
Wheat is one of the most common causes in food-induced anaphylaxis and food dependent, exercised induced anaphylaxis. Gold standard for diagnose food allergy is double blind placebo control food challenge, but it is a high risk procedure. The accuracy of skin prick test and specific IgE assay showed unsatisfactory results. It might be explained by these tests may not detect all of the major allergens in wheat allergic patients. Previous studies showed that the major allergens of wheat dependent, exercised induced anaphylaxis are omega5 gliadin, followed by high molecular weight glutenin. For IgE-mediated wheat allergy, the major allergens varied among studies, including omega5 gliadin, glutenin, alpha/beta/gamma gliadin, and the water-soluble part of wheat allergens. There is no study to direct compare the major allergen between patients who have low wheat specific IgE and very high wheat specific IgE. Also, there is no data about the major allergens of wheat anaphylaxis in Thai population.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Major Allergen in Wheat Anaphylaxis in Thai Population
Actual Study Start Date : April 5, 2017
Actual Primary Completion Date : March 5, 2018
Actual Study Completion Date : March 5, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anaphylaxis

Arm Intervention/treatment
Experimental: specific IgE
Different level of specific IgE and immunoblot
Diagnostic Test: immunoblot

Primary Outcome Measures :
  1. Major allergen sensitized by Thai Patients with Wheat anaphylaxis [ Time Frame: 1 hour ]
    To Identify major allergen (most component of protein that cause wheat allergy) between wheat anaphylaxis (low Specific IgE and high Specific IgE) and wheat dependent, exercise induced anaphylaxis by using immunoblot method (Electrophoresis). The results will be shown in electrophoresis gel and can identify in molecular weight (KDa) of protein which represent to major allergen of wheat protein.

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Wheat anaphylaxis patient aged 1-60 years, who received treatment at division of allergy, department of Pediatrics and Medicine, Siriraj Hospital from 2001 to 2016

Exclusion Criteria:

  • Loss follow up
  • No consent form
  • Celiac disease, Autoimmune disease was diagnosed

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 identifier (NCT number): NCT03487315

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Siriraj Hospital
Bangkok Noi, Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
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Principal Investigator: Punchama Pacharn, MD Mahidol University
Publications of Results:
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Responsible Party: Mahidol University Identifier: NCT03487315    
Other Study ID Numbers: 842/2559(EC3)
First Posted: April 4, 2018    Key Record Dates
Last Update Posted: April 4, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Wheat Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Pathologic Processes
Food Hypersensitivity