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

NCT ID: NCT04013763

Last Updated: 2022-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-01

Study Completion Date

2020-08-31

Brief Summary

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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

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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.

Conditions

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Wheat Allergy Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Atopic dermatitis with stop using product

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

Group Type EXPERIMENTAL

wheat containing skin care products

Intervention Type OTHER

stop or continue using wheat containing skin care products

Atopic dermatitis with containing using product

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

Group Type EXPERIMENTAL

wheat containing skin care products

Intervention Type OTHER

stop or continue using wheat containing skin care products

Non atopic dermatitis with stop using product

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

Group Type EXPERIMENTAL

wheat containing skin care products

Intervention Type OTHER

stop or continue using wheat containing skin care products

Non atopic dermatitis with continue using product

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

Group Type EXPERIMENTAL

wheat containing skin care products

Intervention Type OTHER

stop or continue using wheat containing skin care products

Atopic dermatitis with no product use

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Non atopic dermatitis with no product use

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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wheat containing skin care products

stop or continue using wheat containing skin care products

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

1 Year

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Research Council of Thailand

OTHER_GOV

Sponsor Role collaborator

Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Punchama Pacharn, MD

Role: PRINCIPAL_INVESTIGATOR

Mahidol University

Locations

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Siriraj hospital

Bangkok Noi, Bangkok, Thailand

Site Status

Countries

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Thailand

References

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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.

Reference Type RESULT
PMID: 24759554 (View on PubMed)

Other Identifiers

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038/2562(EC1)

Identifier Type: -

Identifier Source: org_study_id

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