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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:
ClinicalTrials.gov Identifier:
NCT01070368
First Posted: February 18, 2010
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
nittida pannakapitak, Mahidol University
  Purpose
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.

Condition Intervention
Wheat Allergy Other: Commercial extract and in-house wheat extract

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Accuracy Of Skin Prick Test Using In-house Wheat Extract For The Diagnosis Of IgE-mediated Wheat Allergy: A Pilot Study

Resource links provided by NLM:


Further study details as provided by nittida pannakapitak, Mahidol University:

Primary Outcome Measures:
  • correlation skin test result and food challenge result [ Time Frame: 3 year ]

Secondary Outcome Measures:
  • comparison of skin test result and specific IgE to challenge result [ Time Frame: 3 year ]

Enrollment: 30
Study Start Date: June 2009
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01070368


Locations
Thailand
Pediatric department, Faculty of medicine Siriraj hospital, Mahidol university
Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
  More Information

Responsible Party: nittida pannakapitak, Principal investigator, Mahidol University
ClinicalTrials.gov Identifier: NCT01070368     History of Changes
Other Study ID Numbers: 231/2552(EC4)
First Submitted: February 16, 2010
First Posted: February 18, 2010
Last Update Posted: October 12, 2017
Last Verified: February 2013

Keywords provided by nittida pannakapitak, Mahidol University:
skin test
open wheat challenge

Additional relevant MeSH terms:
Hypersensitivity
Wheat Hypersensitivity
Immune System Diseases
Food Hypersensitivity
Hypersensitivity, Immediate