Major Allergen in Wheat Anaphylaxis in Thai Population

Wheat Allergy Clinical Trial

Official title:

Major Allergen in Wheat Anaphylaxis in Thai Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03487315
• Other study ID #: 842/2559(EC3)
• Status: Completed
• Phase: N/A
• First received: August 31, 2017
• Last updated: March 27, 2018
• Start date: April 5, 2017
• Est. completion date: March 5, 2018

Study information

• Verified date: March 2018
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

• To study Major allergen in Wheat anaphylaxis in Thai population

• To study and compare demographic data between group of wheat anaphylaxis

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: March 5, 2018
• Est. primary completion date: March 5, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Anaphylaxis
• Anaphylaxis Exercise
• Anaphylaxis Food
• Wheat Allergy
• Wheat Hypersensitivity

Intervention

Diagnostic Test:
• immunoblot
immunoblot

Locations

Country	Name	City	State
Thailand	Siriraj Hospital	Bangkok Noi	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

References & Publications (1)

Nilsson N, Sjölander 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. d — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 hour