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The Natural History of Wheat Hypersensitivity in Thai Children

M

Mahidol University

Status

Completed

Conditions

Child
Wheat Allergy

Treatments

Dietary Supplement: oral wheat challenge

Study type

Interventional

Funder types

Other

Identifiers

NCT01801748
490/2555(EC3)

Details and patient eligibility

About

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.

Full 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.

Enrollment

43 patients

Sex

All

Ages

1 to 15 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

43 participants in 1 patient group

oral wheat challenge
Experimental group
Treatment:
Dietary Supplement: oral wheat challenge

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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