- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01070368
Accuracy Of Skin Prick Test Using In-house Wheat Extract For The Diagnosis Of IgE-mediated Wheat Allergy: A Pilot Study
February 27, 2013 updated by: nittida pannakapitak, Mahidol University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Bangkok, Thailand, 10700
- Pediatric department, Faculty of medicine Siriraj hospital, Mahidol university
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 15 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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)
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
correlation skin test result and food challenge result
Time Frame: 3 year
|
3 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
comparison of skin test result and specific IgE to challenge result
Time Frame: 3 year
|
3 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2009
Primary Completion (Actual)
October 1, 2012
Study Completion (Actual)
October 1, 2012
Study Registration Dates
First Submitted
February 16, 2010
First Submitted That Met QC Criteria
February 17, 2010
First Posted (Estimate)
February 18, 2010
Study Record Updates
Last Update Posted (Estimate)
February 28, 2013
Last Update Submitted That Met QC Criteria
February 27, 2013
Last Verified
February 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 231/2552(EC4)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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