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.
Sponsor:
Information provided by (Responsible Party):
nittida pannakapitak, Mahidol University
ClinicalTrials.gov Identifier:
NCT01070368
First received: February 16, 2010
Last updated: February 27, 2013
Last verified: February 2013

February 16, 2010
February 27, 2013
June 2009
October 2012   (final data collection date for primary outcome measure)
correlation skin test result and food challenge result [ Time Frame: 3 year ] [ Designated as safety issue: Yes ]
correlation skin test result and food challenge result [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01070368 on ClinicalTrials.gov Archive Site
comparison of skin test result and specific IgE to challenge result [ Time Frame: 3 year ] [ Designated as safety issue: No ]
comparison of skin test result and specific IgE to challenge result [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Accuracy Of Skin Prick Test Using In-house Wheat Extract For The Diagnosis Of IgE-mediated Wheat Allergy: A Pilot Study
Accuracy Of Skin Prick Test Using In-house Wheat Extract For The Diagnosis Of IgE-mediated Wheat Allergy: A Pilot Study

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.

Not Provided
Interventional
Not Provided
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Wheat Allergy
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.
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)
Intervention: Other: Commercial extract and in-house wheat extract
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
October 2012
October 2012   (final data collection date for primary outcome measure)

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
Both
1 Year to 15 Years
No
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT01070368
231/2552(EC4)
No
nittida pannakapitak, Mahidol University
Mahidol University
Not Provided
Not Provided
Mahidol University
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP