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The Natural History of Wheat Hypersensitivity in Thai Children

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01801748
First Posted: March 1, 2013
Last Update Posted: April 9, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Research Council of Thailand
Information provided by (Responsible Party):
Mahidol University
  Purpose
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.

Condition Intervention
Wheat Allergy Child Dietary Supplement: oral wheat challenge

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Natural History of Wheat Hypersensitivity in Thai Children

Resource links provided by NLM:


Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • The number of participants who outgrow from wheat allergy [ Time Frame: 2 years ]

Enrollment: 43
Study Start Date: November 2012
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: oral wheat challenge Dietary Supplement: oral wheat challenge

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01801748


Locations
Thailand
Siriraj hospital
Bangkoknoi, Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
National Research Council of Thailand
Investigators
Principal Investigator: Punchama Pacharn, MD Mahidol University
  More Information

Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT01801748     History of Changes
Other Study ID Numbers: 490/2555(EC3)
First Submitted: February 26, 2013
First Posted: March 1, 2013
Last Update Posted: April 9, 2015
Last Verified: April 2015

Keywords provided by Mahidol University:
wheat allergy
wheat outgrowing
wheat hypersensitivity
omega-5-gliadin
natural history of wheat hypersensitivity

Additional relevant MeSH terms:
Hypersensitivity
Wheat Hypersensitivity
Immune System Diseases
Food Hypersensitivity
Hypersensitivity, Immediate