Back to resultsAccuracy Of Skin Prick Test Using In-house Wheat Extract For The Diagnosis Of IgE-mediated Wheat Allergy: A Pilot Study
Primary Purpose
Wheat Allergy
Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Commercial extract and in-house wheat extract
Sponsored by
About this trial
This is an interventional diagnostic trial for Wheat Allergy focused on measuring skin test, open wheat challenge
Eligibility Criteria
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
Sites / Locations
- Pediatric department, Faculty of medicine Siriraj hospital, Mahidol university
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Food challenge, skin test
Arm Description
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)
Outcomes
Primary Outcome Measures
correlation skin test result and food challenge result
Secondary Outcome Measures
comparison of skin test result and specific IgE to challenge result
Full Information
NCT ID
NCT01070368
First Posted
February 16, 2010
Last Updated
February 27, 2013
Sponsor
Mahidol University
1. Study Identification
Unique Protocol Identification Number
NCT01070368
Brief Title
Accuracy Of Skin Prick Test Using In-house Wheat Extract For The Diagnosis Of IgE-mediated Wheat Allergy: A Pilot Study
Official Title
Accuracy Of Skin Prick Test Using In-house Wheat Extract For The Diagnosis Of IgE-mediated Wheat Allergy: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mahidol University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wheat Allergy
Keywords
skin test, open wheat challenge
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Food challenge, skin test
Arm Type
Experimental
Arm Description
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)
Intervention Type
Other
Intervention Name(s)
Commercial extract and in-house wheat extract
Intervention Description
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.
Primary Outcome Measure Information:
Title
correlation skin test result and food challenge result
Time Frame
3 year
Secondary Outcome Measure Information:
Title
comparison of skin test result and specific IgE to challenge result
Time Frame
3 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Pediatric department, Faculty of medicine Siriraj hospital, Mahidol university
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
12. IPD Sharing Statement
Learn more about this trial
Accuracy Of Skin Prick Test Using In-house Wheat Extract For The Diagnosis Of IgE-mediated Wheat Allergy: A Pilot Study
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