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Accuracy Of Skin Prick Test Using In-house Wheat Extract For The Diagnosis Of IgE-mediated Wheat Allergy: A Pilot Study

This study has been completed.
Information provided by (Responsible Party):
nittida pannakapitak, Mahidol University Identifier:
First received: February 16, 2010
Last updated: February 27, 2013
Last verified: February 2013
Nowadays, commercial wheat extract is widely accessible, and is used for skin prick test for wheat allergy. However, commercial wheat extracted for skin prick test have less precise test result compared to extract from omega-5 gliadin, which is one of the major allergen with immediate wheat allergy.

Condition Intervention
Wheat Allergy
Other: Commercial extract and in-house wheat extract

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Accuracy Of Skin Prick Test Using In-house Wheat Extract For The Diagnosis Of IgE-mediated Wheat Allergy: A Pilot Study

Resource links provided by NLM:

Further study details as provided by nittida pannakapitak, Mahidol University:

Primary Outcome Measures:
  • correlation skin test result and food challenge result [ Time Frame: 3 year ]

Secondary Outcome Measures:
  • comparison of skin test result and specific IgE to challenge result [ Time Frame: 3 year ]

Enrollment: 30
Study Start Date: June 2009
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Food challenge, skin test
Skin test by two extract commercial, and in-house extract. and open challenge with wheat (except in patient with history of wheat anaphylaxis: assume as challenge positive)
Other: Commercial extract and in-house wheat extract
Patients with a history of wheat allergy underwent two skin test extracts, and open challenge with wheat. A blood test for specific IgE was performed in the same time.


Ages Eligible for Study:   1 Year to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • A patient with the age of 1-15 year old
  • A history of symptoms that suspected of type 1 hypersensitivity (eg. Urticaria, angioedema, wheezing, anaphylaxis) occur within 4 hours after wheat ingestion.
  • Patients attend in allergy clinic, pediatric department, Siriraj hospital since 2007-2012

Exclusion Criteria:

  • First sign and symptom happens more than 4 hours since wheat ingestion
  • Have underlying disease such as heart disease, epilepsy etc.
  • Have contraindication for performed skin prick test
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Please refer to this study by its identifier: NCT01070368

Pediatric department, Faculty of medicine Siriraj hospital, Mahidol university
Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
  More Information

Responsible Party: nittida pannakapitak, Principal investigator, Mahidol University Identifier: NCT01070368     History of Changes
Other Study ID Numbers: 231/2552(EC4)
Study First Received: February 16, 2010
Last Updated: February 27, 2013

Keywords provided by nittida pannakapitak, Mahidol University:
skin test
open wheat challenge

Additional relevant MeSH terms:
Wheat Hypersensitivity
Immune System Diseases
Food Hypersensitivity
Hypersensitivity, Immediate processed this record on May 25, 2017