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Clinical Trials/NCT01070368
NCT01070368CompletedNot Applicable

Accuracy Of Skin Prick Test Using In-house Wheat Extract For The Diagnosis Of IgE-mediated Wheat Allergy: A Pilot Study

Mahidol University1 site in 1 country30 target enrollmentStarted: June 1, 2009Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
30
Locations
1
Primary Endpoint
correlation skin test result and food challenge result
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Intervention Model
Parallel
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
1 Year to 15 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Food challenge, skin test

Experimental

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: Commercial extract and in-house wheat extract (Other)

Outcomes

Primary Outcomes

correlation skin test result and food challenge result

Time Frame: 3 year

Secondary Outcomes

  • comparison of skin test result and specific IgE to challenge result(3 year)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

nittida pannakapitak

Principal investigator

Mahidol University

Study Sites (1)

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