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The Natural History of Wheat Hypersensitivity in Thai Children

Primary Purpose

Wheat Allergy, Child

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
oral wheat challenge
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Wheat Allergy focused on measuring wheat allergy, wheat outgrowing, wheat hypersensitivity, omega-5-gliadin, natural history of wheat hypersensitivity

Eligibility Criteria

1 Year - 15 Years (Child)All SexesDoes not accept 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.

Sites / Locations

  • Siriraj hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

oral wheat challenge

Arm Description

Outcomes

Primary Outcome Measures

The number of participants who outgrow from wheat allergy

Secondary Outcome Measures

Full Information

First Posted
February 26, 2013
Last Updated
April 7, 2015
Sponsor
Mahidol University
Collaborators
National Research Council of Thailand
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1. Study Identification

Unique Protocol Identification Number
NCT01801748
Brief Title
The Natural History of Wheat Hypersensitivity in Thai Children
Official Title
The Natural History of Wheat Hypersensitivity in Thai Children
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mahidol University
Collaborators
National Research Council of Thailand

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wheat Allergy, Child
Keywords
wheat allergy, wheat outgrowing, wheat hypersensitivity, omega-5-gliadin, natural history of wheat hypersensitivity

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
oral wheat challenge
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
oral wheat challenge
Primary Outcome Measure Information:
Title
The number of participants who outgrow from wheat allergy
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Punchama Pacharn, MD
Organizational Affiliation
Mahidol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Siriraj hospital
City
Bangkoknoi
State/Province
Bangkok
ZIP/Postal Code
10700
Country
Thailand

12. IPD Sharing Statement

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The Natural History of Wheat Hypersensitivity in Thai Children

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