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

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ClinicalTrials.gov Identifier: NCT04013763
Recruitment Status : Terminated (
  1. Limit number of patients during COVID-19 situation
  2. Too small number of wheat allergic patients who are using wheat containing soap
)
First Posted : July 10, 2019
Last Update Posted : September 7, 2020
Sponsor:
Collaborator:
National Research Council of Thailand
Information provided by (Responsible Party):
Mahidol University

Tracking Information
First Submitted Date  ICMJE July 1, 2019
First Posted Date  ICMJE July 10, 2019
Last Update Posted Date September 7, 2020
Actual Study Start Date  ICMJE July 1, 2019
Actual Primary Completion Date August 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 17, 2019)
Specific IgE to wheat and omega-5 gliadin level [ Time Frame: 1 year ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 8, 2019)
Specific IgE to wheat and omega-5 gliadin level [ Time Frame: 1 year ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 17, 2019)
level of transepidermal water loss [ Time Frame: 1 year ]
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 8, 2019)
level of transepidermal water loss [ Time Frame: 1 year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Outcome of Specific IgE Level in Children With IgE-mediated Wheat Allergy After Stop Using Wheat Containing Skin Care
Official Title  ICMJE Outcome of Specific IgE Level in Children With IgE-mediated Wheat Allergy After Stop Using Wheat Containing Skin Care
Brief 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.
Detailed 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Wheat Allergy
  • Children
Intervention  ICMJE Other: wheat containing skin care products
stop or continue using wheat containing skin care products
Study Arms  ICMJE
  • Experimental: Atopic dermatitis with stop using product
    case wheat allergy with atopic dermatitis and stop using wheat containing skin care products
    Intervention: Other: wheat containing skin care products
  • Experimental: Atopic dermatitis with containing using product
    case wheat allergy with atopic dermatitis and continue using wheat containing skin care products
    Intervention: Other: wheat containing skin care products
  • Experimental: Non atopic dermatitis with stop using product
    case wheat allergy with normal skin and stop using wheat containing skin care products
    Intervention: Other: wheat containing skin care products
  • Experimental: Non atopic dermatitis with continue using product
    case wheat allergy with normal skin and continue using wheat containing skin care products
    Intervention: Other: wheat containing skin care products
  • No Intervention: Atopic dermatitis with no product use
    case wheat allergy who does not use wheat containing skin care products and has atopic dermatitis
  • No Intervention: Non atopic dermatitis with no product use
    case wheat allergy who does not use wheat containing skin care products and no atopic dermatitis
Publications * 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: correlation of its titer and clinical severity. Allergol Int. 2014 Jun;63(2):243-9. doi: 10.2332/allergolint.13-OA-0618. Epub 2014 Apr 25.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: September 3, 2020)
7
Original Estimated Enrollment  ICMJE
 (submitted: July 8, 2019)
150
Actual Study Completion Date  ICMJE August 31, 2020
Actual Primary Completion Date August 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04013763
Other Study ID Numbers  ICMJE 038/2562(EC1)
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mahidol University
Study Sponsor  ICMJE Mahidol University
Collaborators  ICMJE National Research Council of Thailand
Investigators  ICMJE
Principal Investigator: Punchama Pacharn, MD Mahidol University
PRS Account Mahidol University
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP