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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

Primary Purpose

Wheat Allergy

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Commercial extract and in-house wheat extract
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Wheat Allergy focused on measuring skin test, open wheat challenge

Eligibility Criteria

1 Year - 15 Years (Child)All SexesDoes not accept healthy volunteers

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

First Posted
February 16, 2010
Last Updated
February 27, 2013
Sponsor
Mahidol University
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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

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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

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