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CompletedNCT01070368Updated Feb 28, 2013

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

An interventional study of Commercial extract and in-house wheat extract in Wheat Allergy, sponsored by Mahidol University. Completed at 1 site in Thailand. Open to participants aged 1 Year to 15 Years. Per ClinicalTrials.gov, last updated 2013-02-28.

Sponsored by Mahidol University · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
30
Ages
1 Year to 15 Years
Sex
All
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Study 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.

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Conditions studied

  • Wheat Allergy

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Keywords

  • skin test
  • open wheat challenge
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In context

Hypersensitivity

1,916 studies on the registry are indexed under Hypersensitivity; 265 are open to participants now.

This study's enrollment of 30 is below the median of 57 across 1,384 interventional studies indexed under Hypersensitivity.

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Lead sponsor

Mahidol University is the lead sponsor of 730 studies on the registry; 118 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
1 Year to 15 Years
Sexes eligible
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

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
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • 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

Interventions

  • OtherCommercial 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.

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What researchers measure

Primary outcomes

  1. correlation skin test result and food challenge result

    Time frame: 3 year

Secondary outcomes

  1. comparison of skin test result and specific IgE to challenge result

    Time frame: 3 year

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Study locations

1 site
  • Pediatric department, Faculty of medicine Siriraj hospital, Mahidol university
    Bangkok, 10700, Thailand
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 28, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01070368
Lead sponsor
Mahidol University
Responsible party
nittida pannakapitak (Principal investigator, Mahidol University) — Principal investigator
First posted
Feb 18, 2010
Start date
Jun 2009
Primary completion
Oct 2012
Completion
Oct 2012
Last update
Feb 28, 2013

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.

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