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

Primary Purpose

Wheat Allergy, Children

Status
Terminated
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
wheat containing skin care products
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Wheat Allergy focused on measuring wheat allergy, skin sensitization, specific IgE, wheat containing skin care

Eligibility Criteria

1 Year - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Siriraj hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

No Intervention

No Intervention

Arm Label

Atopic dermatitis with stop using product

Atopic dermatitis with containing using product

Non atopic dermatitis with stop using product

Non atopic dermatitis with continue using product

Atopic dermatitis with no product use

Non atopic dermatitis with no product use

Arm Description

case wheat allergy with atopic dermatitis and stop using wheat containing skin care products

case wheat allergy with atopic dermatitis and continue using wheat containing skin care products

case wheat allergy with normal skin and stop using wheat containing skin care products

case wheat allergy with normal skin and continue using wheat containing skin care products

case wheat allergy who does not use wheat containing skin care products and has atopic dermatitis

case wheat allergy who does not use wheat containing skin care products and no atopic dermatitis

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
July 1, 2019
Last Updated
April 7, 2022
Sponsor
Mahidol University
Collaborators
National Research Council of Thailand
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1. Study Identification

Unique Protocol Identification Number
NCT04013763
Brief Title
Outcome of Specific IgE Level in Children With IgE-mediated Wheat Allergy After Stop Using Wheat Containing Skin Care
Official Title
Outcome of Specific IgE Level in Children With IgE-mediated Wheat Allergy After Stop Using Wheat Containing Skin Care
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Terminated
Why Stopped
Limit number of patients during COVID-19 situation Too small number of wheat allergic patients who are using wheat containing soap
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
August 31, 2020 (Actual)
Study Completion Date
August 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mahidol University
Collaborators
National Research Council of Thailand

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wheat Allergy, Children
Keywords
wheat allergy, skin sensitization, specific IgE, wheat containing skin care

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Atopic dermatitis with stop using product
Arm Type
Experimental
Arm Description
case wheat allergy with atopic dermatitis and stop using wheat containing skin care products
Arm Title
Atopic dermatitis with containing using product
Arm Type
Experimental
Arm Description
case wheat allergy with atopic dermatitis and continue using wheat containing skin care products
Arm Title
Non atopic dermatitis with stop using product
Arm Type
Experimental
Arm Description
case wheat allergy with normal skin and stop using wheat containing skin care products
Arm Title
Non atopic dermatitis with continue using product
Arm Type
Experimental
Arm Description
case wheat allergy with normal skin and continue using wheat containing skin care products
Arm Title
Atopic dermatitis with no product use
Arm Type
No Intervention
Arm Description
case wheat allergy who does not use wheat containing skin care products and has atopic dermatitis
Arm Title
Non atopic dermatitis with no product use
Arm Type
No Intervention
Arm Description
case wheat allergy who does not use wheat containing skin care products and no atopic dermatitis
Intervention Type
Other
Intervention Name(s)
wheat containing skin care products
Intervention Description
stop or continue using wheat containing skin care products
Primary Outcome Measure Information:
Title
Specific IgE to wheat and omega-5 gliadin level
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
level of transepidermal water loss
Description
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.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Punchama Pacharn, MD
Organizational Affiliation
Mahidol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Siriraj hospital
City
Bangkok noi
State/Province
Bangkok
ZIP/Postal Code
10700
Country
Thailand

12. IPD Sharing Statement

Citations:
PubMed Identifier
24759554
Citation
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.
Results Reference
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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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