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

Wheat Allergy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01070368
• Other study ID #: 231/2552(EC4)
• Status: Completed
• Phase: N/A
• First received: February 16, 2010
• Last updated: February 27, 2013
• Start date: June 2009
• Est. completion date: October 2012

Study information

• Verified date: February 2013
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypersensitivity
• Wheat Allergy
• Wheat Hypersensitivity

Intervention

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.

Locations

Country	Name	City	State
Thailand	Pediatric department, Faculty of medicine Siriraj hospital, Mahidol university	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	correlation skin test result and food challenge result		3 year
Secondary	comparison of skin test result and specific IgE to challenge result		3 year