The Natural History of Wheat Hypersensitivity in Thai Children

This study has been completed.
Sponsor:
Collaborator:
National Research Council of Thailand
Information provided by (Responsible Party):
Mahidol University
ClinicalTrials.gov Identifier:
NCT01801748
First received: February 26, 2013
Last updated: April 7, 2015
Last verified: April 2015
  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: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   1 Year to 15 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT01801748     History of Changes
Other Study ID Numbers: 490/2555(EC3)
Study First Received: February 26, 2013
Last Updated: April 7, 2015
Health Authority: Thailand: Ethical Committee

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
Food Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases

ClinicalTrials.gov processed this record on April 16, 2015