The Natural History of Wheat Hypersensitivity in Thai Children

Child Clinical Trial

Official title:

The Natural History of Wheat Hypersensitivity in Thai Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01801748
• Other study ID #: 490/2555(EC3)
• Status: Completed
• Phase: N/A
• First received: February 26, 2013
• Last updated: April 7, 2015
• Start date: November 2012
• Est. completion date: April 2014

Study information

• Verified date: April 2015
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 15 Years

Eligibility

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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Child
• Hypersensitivity
• Wheat Allergy
• Wheat Hypersensitivity

Intervention

Dietary Supplement:
• oral wheat challenge

Locations

Country	Name	City	State
Thailand	Siriraj hospital	Bangkoknoi	Bangkok

Sponsors (2)

Lead Sponsor	Collaborator
Mahidol University	National Research Council of Thailand

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of participants who outgrow from wheat allergy		2 years	Yes