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CompletedNCT03487315Updated Apr 4, 2018

Major Allergen in Wheat Anaphylaxis in Thai Population

An interventional study of immunoblot in Wheat Allergy, Anaphylaxis Food and Anaphylaxis Exercise, sponsored by Mahidol University. Completed at 1 site in Thailand. Open to participants aged 1 Year to 60 Years. Per ClinicalTrials.gov, last updated 2018-04-04.

Sponsored by Mahidol University · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Apr 2017, registered Aug 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Not applicable
Ages
1 Year to 60 Years
Sex
All
01

Study summary

  • To study Major allergen in Wheat anaphylaxis in Thai population
  • To study and compare demographic data between group of wheat anaphylaxis
Read the 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.

02

Conditions studied

  • Wheat Allergy
  • Anaphylaxis Food
  • Anaphylaxis Exercise

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03

In context

Wheat Hypersensitivity

20 studies on the registry are indexed under Wheat Hypersensitivity; 5 are open to participants now.

This study's enrollment of 36 is below the median of 46 across 14 interventional studies indexed under Wheat Hypersensitivity.

Browse Wheat Hypersensitivity studies →

Lead sponsor

Mahidol University is the lead sponsor of 747 studies on the registry; 119 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Loss follow up
  • No consent form
  • Celiac disease, disease was diagnosed
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
36 participants (actual)

Study arms

  • Experimental
    specific IgE

    Different level of specific IgE and immunoblot

    Diagnostic Test: immunoblot

Interventions

  • Diagnostic testimmunoblot

    immunoblot

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 hour

07

Study locations

1 site
  • Siriraj Hospital
    Bangkok Noi, Bangkok 10700, Thailand
08

References and documents

Publications

  • 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. PubMed 25601168 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 4, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03487315
Lead sponsor
Mahidol University
Responsible party
Sponsor
First posted
Apr 4, 2018
Start date
Apr 5, 2017
Primary completion
Mar 5, 2018
Completion
Mar 5, 2018
Last update
Apr 4, 2018

Study contacts

Punchama Pacharn, MD
principal investigator · Mahidol University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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