The Natural History of Wheat Hypersensitivity in Thai Children
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.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||The Natural History of Wheat Hypersensitivity in Thai Children|
- The number of participants who outgrow from wheat allergy [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2012|
|Study Completion Date:||April 2014|
|Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
|Experimental: oral wheat challenge||Dietary Supplement: oral wheat challenge|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01801748
|Bangkoknoi, Bangkok, Thailand, 10700|
|Principal Investigator:||Punchama Pacharn, MD||Mahidol University|