Completed

The Natural History of Wheat Hypersensitivity in Thai Children

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What is being tested

oral wheat challenge

Dietary Supplement
Who is being recruted

Food Hypersensitivity+2

+ Hypersensitivity

+ Hypersensitivity, Immediate

From 1 to 15 Years
+4 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Diagnostic Study

Interventional
Study Start: November 2012
See protocol details

Summary

Principal SponsorMahidol University
Last updated: April 9, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01801748
Principal SponsorMahidol University
Last updated: April 9, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

43 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Diagnostic Study

Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 1 to 15 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Food HypersensitivityHypersensitivityHypersensitivity, ImmediateImmune System DiseasesWheat Hypersensitivity

Criteria

2 inclusion criteria required to participate
History of IgE-mediated wheat allergy
children 1 to 15 years
2 exclusion criteria prevent from participating
Parents refused to sign the consent
Patient has the underlying disease: congenital heart disease, uncontrolled asthma or life-threatening condition

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Siriraj hospital

Bangkoknoi, ThailandOpen Siriraj hospital in Google Maps
CompletedOne Study Center