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
  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: 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 Mahidol University:

Primary Outcome Measures:
  • correlation skin test result and food challenge result [ Time Frame: 3 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • comparison of skin test result and specific IgE to challenge result [ Time Frame: 3 year ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   1 Year to 15 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01070368

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

No publications provided

Responsible Party: nittida pannakapitak, Principal investigator, Mahidol University
ClinicalTrials.gov Identifier: NCT01070368     History of Changes
Other Study ID Numbers: 231/2552(EC4)
Study First Received: February 16, 2010
Last Updated: February 27, 2013
Health Authority: Thailand: Ethical Committee

Keywords provided by Mahidol University:
skin test
open wheat challenge

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

ClinicalTrials.gov processed this record on September 11, 2014