NCT01801748

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 26, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 1, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

April 9, 2015

Status Verified

April 1, 2015

Enrollment Period

1.4 years

First QC Date

February 26, 2013

Last Update Submit

April 7, 2015

Conditions

Wheat AllergyChild

Keywords

wheat allergywheat outgrowingwheat hypersensitivityomega-5-gliadinnatural history of wheat hypersensitivity

Outcome Measures

Primary Outcomes (1)

  • The number of participants who outgrow from wheat allergy

    2 years

Study Arms (1)

oral wheat challenge

EXPERIMENTAL
Dietary Supplement: oral wheat challenge

Interventions

oral wheat challengeDIETARY_SUPPLEMENT
oral wheat challenge

Eligibility Criteria

Age1 Year - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • children 1 to 15 years
  • History of IgE-mediated wheat allergy

You may not qualify if:

  • Parents refused to sign the consent
  • Patient has the underlying disease: congenital heart disease, uncontrolled asthma or life-threatening condition.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Siriraj hospital

Bangkoknoi, Bangkok, 10700, Thailand

Location

MeSH Terms

Conditions

Wheat Hypersensitivity

Condition Hierarchy (Ancestors)

Food HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Punchama Pacharn, MD

    Mahidol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2013

First Posted

March 1, 2013

Study Start

November 1, 2012

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

April 9, 2015

Record last verified: 2015-04

Locations

TH(1)