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OpenTrials
Completed

NCT Number: NCT01801748

The Natural History of Wheat Hypersensitivity in Thai Children

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.

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Key information

Age range

1 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Siriraj hospital

Bangkoknoi, Bangkok, 10700, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

oral wheat challenge

Dietary Supplement

Primary outcomes

  1. The number of participants who outgrow from wheat allergy

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Collaborators

  • National Research Council of Thailand

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Mar 1, 2013
Registry last updated
Apr 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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