- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01801748
The Natural History of Wheat Hypersensitivity in Thai Children
April 7, 2015 updated by: Mahidol University
Wheat allergy is affected 0.4-1% and is a major staple of the worldwide diet.
Wheat avoidance is exceedingly difficult and imposes major dietary restriction.
The purpose of this study were to determine the rate of oral tolerance and identify clinical and laboratory predictors of tolerance development in Thai children who allergic to wheat.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
All children in this study were sensitized to wheat.
Each patient was clinically evaluated, with focus on wheat allergy by both a detailed medical examination and collection of medical history.
Blood sample was taken for baseline determination of ImmunoglobulinE antibodies to wheat and to omega-5-gliadin.
The oral wheat challenge were performed in all study subjects to identify a case of wheat outgrowing.
The primary outcome was the development of oral tolerance to wheat.
Oral wheat challenge were generally performed at least every 1 years if the child did not have an interval history of symptoms with unintentional exposure.
Study Type
Interventional
Enrollment (Actual)
43
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Bangkok
-
Bangkoknoi, Bangkok, Thailand, 10700
- Siriraj Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 15 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- children 1 to 15 years
- History of IgE-mediated wheat allergy
Exclusion Criteria:
- Parents refused to sign the consent
- Patient has the underlying disease: congenital heart disease, uncontrolled asthma or life-threatening condition.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: oral wheat challenge
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The number of participants who outgrow from wheat allergy
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2012
Primary Completion (Actual)
April 1, 2014
Study Completion (Actual)
April 1, 2014
Study Registration Dates
First Submitted
February 26, 2013
First Submitted That Met QC Criteria
February 28, 2013
First Posted (Estimate)
March 1, 2013
Study Record Updates
Last Update Posted (Estimate)
April 9, 2015
Last Update Submitted That Met QC Criteria
April 7, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 490/2555(EC3)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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