NCT01070368

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 18, 2010

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

February 28, 2013

Status Verified

February 1, 2013

Enrollment Period

3.3 years

First QC Date

February 16, 2010

Last Update Submit

February 27, 2013

Conditions

Wheat Allergy

Keywords

skin testopen wheat challenge

Outcome Measures

Primary Outcomes (1)

  • correlation skin test result and food challenge result

    3 year

Secondary Outcomes (1)

  • comparison of skin test result and specific IgE to challenge result

    3 year

Study Arms (1)

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)

Other: Commercial extract and in-house wheat extract

Interventions

Commercial extract and in-house wheat extractOTHER

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.

Food challenge, skin test

Eligibility Criteria

Age1 Year - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pediatric department, Faculty of medicine Siriraj hospital, Mahidol university

Bangkok, 10700, Thailand

Location

MeSH Terms

Conditions

Wheat Hypersensitivity

Condition Hierarchy (Ancestors)

Food HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

February 16, 2010

First Posted

February 18, 2010

Study Start

June 1, 2009

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

February 28, 2013

Record last verified: 2013-02

Locations

TH(1)