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Major Allergen in Wheat Anaphylaxis in Thai Population

Primary Purpose

Wheat Allergy, Anaphylaxis Food, Anaphylaxis Exercise

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
immunoblot
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Wheat Allergy

Eligibility Criteria

1 Year - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Siriraj Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

specific IgE

Arm Description

Different level of specific IgE and immunoblot

Outcomes

Primary Outcome Measures

Major allergen sensitized by Thai Patients with Wheat anaphylaxis
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.

Secondary Outcome Measures

Full Information

First Posted
August 31, 2017
Last Updated
March 27, 2018
Sponsor
Mahidol University
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1. Study Identification

Unique Protocol Identification Number
NCT03487315
Brief Title
Major Allergen in Wheat Anaphylaxis in Thai Population
Official Title
Major Allergen in Wheat Anaphylaxis in Thai Population
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
April 5, 2017 (Actual)
Primary Completion Date
March 5, 2018 (Actual)
Study Completion Date
March 5, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mahidol University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wheat Allergy, Anaphylaxis Food, Anaphylaxis Exercise

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
specific IgE
Arm Type
Experimental
Arm Description
Different level of specific IgE and immunoblot
Intervention Type
Diagnostic Test
Intervention Name(s)
immunoblot
Intervention Description
immunoblot
Primary Outcome Measure Information:
Title
Major allergen sensitized by Thai Patients with Wheat anaphylaxis
Description
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.
Time Frame
1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Punchama Pacharn, MD
Organizational Affiliation
Mahidol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Siriraj Hospital
City
Bangkok Noi
State/Province
Bangkok
ZIP/Postal Code
10700
Country
Thailand

12. IPD Sharing Statement

Citations:
PubMed Identifier
25601168
Citation
Nilsson N, Sjolander S, Baar A, Berthold M, Pahr S, Vrtala S, Valenta R, Morita E, Hedlin G, Borres MP, Nilsson C. Wheat allergy in children evaluated with challenge and IgE antibodies to wheat components. Pediatr Allergy Immunol. 2015 Mar;26(2):119-25. doi: 10.1111/pai.12334.
Results Reference
result

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Major Allergen in Wheat Anaphylaxis in Thai Population

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