Outcome of Specific IgE Level in Children With IgE-mediated Wheat Allergy After Stop Using Wheat Containing Skin Care

Children Clinical Trial

Official title:

Outcome of Specific IgE Level in Children With IgE-mediated Wheat Allergy After Stop Using Wheat Containing Skin Care

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04013763
• Other study ID #: 038/2562(EC1)
• Status: Terminated
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: August 31, 2020

Study information

• Verified date: April 2022
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Wheat allergy is increasing in Thailand. Some studies show that cutaneous exposure of allergen may cause allergy and there are many wheat containing skin care products that are over-the-counter. So the purpose of our study is to determine level of specific immunoglobulin E antibodies to wheat and omega-5 gliadin in wheat allergy patients after stop using wheat containing skin care products.

Description:

All children in this study were sensitized to wheat. Each patient was clinically evaluated, with focus on wheat allergy by medical history, medical examination included skin status (suspected atopic dermatitis or not). Blood sample was taken for baseline determination of immunoglobulin E antibodies to wheat and to omega-5 gliadin. Transepidermal water loss was examined in case with atopic dermatitis. The primary outcome was the specific immunoglobulin E antibodies to wheat and omega-5 gliadin in case that stop using wheat containing skin care product and case that continue using products.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: August 31, 2020
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

Inclusion Criteria:

• children age 1 to 18 years

• History of IgE-mediated wheat allergy

Exclusion Criteria:

• Parents refused to sign the consent

• severe atopic dermatitis

• on oral immunothery

• severe IgE mediated reaction after using wheat containing skin care product

Related Conditions & MeSH terms

• Children
• Hypersensitivity
• Wheat Allergy
• Wheat Hypersensitivity

Intervention

Other:
• wheat containing skin care products
stop or continue using wheat containing skin care products

Locations

Country	Name	City	State
Thailand	Siriraj hospital	Bangkok noi	Bangkok

Sponsors (2)

Lead Sponsor	Collaborator
Mahidol University	National Research Council of Thailand

Country where clinical trial is conducted

Thailand, 

References & Publications (1)

Nakamura M, Yagami A, Hara K, Sano A, Kobayashi T, Aihara M, Hide M, Chinuki Y, Morita E, Teshima R, Matsunaga K. A new reliable method for detecting specific IgE antibodies in the patients with immediate type wheat allergy due to hydrolyzed wheat protein — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Specific IgE to wheat and omega-5 gliadin level	To follow-up the level of wheat and omega5 gliadin specificIgE after stop using the wheat containing skin care product compare to patients who continue using the product.	1 year
Secondary	level of transepidermal water loss	To follow up the transepidermal water loss in patients with atopic dermatitis, comparing the group that continue using the product to the group that stop using the product.	1 year