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

NCT01070368 — Not applicable, Completed, 30 participants, Mahidol University

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Registry	NCT01070368
Status	Completed
Phase	Not applicable
Study type	Interventional; parallel, masking: none, diagnostic
Enrollment	30 (Actual)
Sponsor	Mahidol University (Other)
Conditions	Wheat Allergy
Interventions	Commercial extract and in-house wheat extract (Other)
Dates	start 2009-06-01, primary completion 2012-10-01, completion 2012-10-01, first posted 2010-02-18, last updated 2013-02-28
Locations	1 site in Thailand

-Summary

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.

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+Arms and interventions

Arm	Type	Interventions	Description
Food challenge, skin test	Experimental	Other: Commercial extract and in-house wheat extract	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)

Commercial extract and in-house wheat extract (Other): 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.

+Outcome measures

Primary outcomes

correlation skin test result and food challenge result [3 year]

Secondary outcomes

comparison of skin test result and specific IgE to challenge result [3 year]

+Eligibility

Sex: All, ages: 1 Year to 15 Years

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

+Locations (1)

Facility	City	Country	Status
Pediatric department, Faculty of medicine Siriraj hospital, Mahidol university	Bangkok	Thailand