Wheat AllergyNCT04013763
Outcome of Specific IgE Level in Children With IgE-mediated Wheat Allergy After Stop Using Wheat Containing Skin Care
A study testing wheat containing skin care products in people with Wheat Allergy and Children, run by Mahidol University at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Wheat Allergy, Children
- What is being tested?
- wheat containing skin care products
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jul 2019to 31 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- children age 1 to 18 years
- History of IgE-mediated wheat allergy
Who cannot join
- Parents refused to sign the consent
- severe atopic dermatitis
- on oral immunothery
- severe IgE mediated reaction after using wheat containing skin care product
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Wheat Allergy, Children
- Being tested
- wheat containing skin care products
- Keywords
- wheat allergy, skin sensitization, specific IgE, wheat containing skin care
- Medical subject headings
- Wheat Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
wheat containing skin care productsOther
stop or continue using wheat containing skin care products
| Study group | Role | What they receive |
|---|---|---|
| Atopic dermatitis with stop using product | Experimental | case wheat allergy with atopic dermatitis and stop using wheat containing skin care products Receives: Other: wheat containing skin care products |
| Atopic dermatitis with containing using product | Experimental | case wheat allergy with atopic dermatitis and continue using wheat containing skin care products Receives: Other: wheat containing skin care products |
| Non atopic dermatitis with stop using product | Experimental | case wheat allergy with normal skin and stop using wheat containing skin care products Receives: Other: wheat containing skin care products |
| Non atopic dermatitis with continue using product | Experimental | case wheat allergy with normal skin and continue using wheat containing skin care products Receives: Other: wheat containing skin care products |
| Atopic dermatitis with no product use | No intervention | case wheat allergy who does not use wheat containing skin care products and has atopic dermatitis |
| Non atopic dermatitis with no product use | No intervention | case wheat allergy who does not use wheat containing skin care products and no atopic dermatitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (1)
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2019
- Study start1 Jul 2019
- Primary completion31 Aug 2020
- Study completion31 Aug 2020
Why it stopped: 1. Limit number of patients during COVID-19 situation 2. Too small number of wheat allergic patients who are using wheat containing soap
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Wheat AllergyStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Council of Thailand
- Responsible party
- Sponsor
- Investigators
- Punchama Pacharn, MD, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04013763
- Sponsor's protocol ID
- 038/2562(EC1)
- Status last verified
- Apr 2022
- First submitted
- 1 Jul 2019
- Last updated
- 8 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 24759554
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Specific IgE Level in Children With IgE-mediated Wheat Allergy After Stop Using Wheat Containing Skin Care
- ClinicalTrials.gov ID
- NCT04013763
- Acronym / sponsor ID
- 038/2562(EC1)
- Conditions
- Wheat Allergy, Children
- Keywords
- wheat allergy, skin sensitization, specific IgE, wheat containing skin care
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: 1. Limit number of patients during COVID-19 situation 2. Too small number of wheat allergic patients who are using wheat containing soap
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Collaborators
- National Research Council of Thailand
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 10 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Atopic dermatitis with stop using product | Experimental | Other: wheat containing skin care productscase wheat allergy with atopic dermatitis and stop using wheat containing skin care products |
| Atopic dermatitis with containing using product | Experimental | Other: wheat containing skin care productscase wheat allergy with atopic dermatitis and continue using wheat containing skin care products |
| Non atopic dermatitis with stop using product | Experimental | Other: wheat containing skin care productscase wheat allergy with normal skin and stop using wheat containing skin care products |
| Non atopic dermatitis with continue using product | Experimental | Other: wheat containing skin care productscase wheat allergy with normal skin and continue using wheat containing skin care products |
| Atopic dermatitis with no product use | No intervention | –case wheat allergy who does not use wheat containing skin care products and has atopic dermatitis |
| Non atopic dermatitis with no product use | No intervention | –case wheat allergy who does not use wheat containing skin care products and no atopic dermatitis |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- children age 1 to 18 years
- History of IgE-mediated wheat allergy
Key exclusion criteria (4 listed)
- Parents refused to sign the consent
- severe atopic dermatitis
- on oral immunothery
- severe IgE mediated reaction after using wheat containing skin care product
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| wheat containing skin care productsstop or continue using wheat containing skin care products | Other | Atopic dermatitis with containing using product, Atopic dermatitis with stop using product, Non atopic dermatitis with continue using product, Non atopic dermatitis with stop using product |
Primary outcome
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.
1 secondary outcome
level of transepidermal water loss
Time frame: 1 year
Results and safety
The study was stopped early (reason given: 1. Limit number of patients during COVID-19 situation 2. Too small number of wheat allergic patients who are using wheat containing soap). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2022.
- Results publication: PubMed 24759554Nakamura 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Punchama Pacharn, MD principal investigator
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing wheat containing skin care products in people with Wheat Allergy and Children, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: 1. Limit number of patients during COVID-19 situation 2. Too small number of wheat allergic patients who are using wheat containing soap). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Specific IgE to wheat and omega-5 gliadin level (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04013763, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2022.