Wheat AllergyNCT01801748
The Natural History of Wheat Hypersensitivity in Thai Children
A study testing oral wheat challenge in people with Wheat Allergy and Child, run by Mahidol University at 1 site in Thailand.
Trial summary
Wheat allergy is affected 0.4-1% and is a major staple of the worldwide diet. Wheat avoidance is exceedingly difficult and imposes major dietary restriction. The purpose of this study were to determine the rate of oral tolerance and identify clinical and laboratory predictors of tolerance development in Thai children… Read more about this study
- Who is it for?
- Ages 1 year to 15 years
- Conditions the study is for
- Wheat Allergy, Child
- What is being tested?
- oral wheat challenge
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteThailand
- Study dates
- Nov 2012to Apr 2014
- 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 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children 1 to 15 years
- History of IgE-mediated wheat allergy
Who cannot join
- Parents refused to sign the consent
- Patient has the underlying disease: congenital heart disease, uncontrolled asthma or life-threatening condition.
Trial locations and contacts
1 site in 1 country.
About this study
Wheat allergy is affected 0.4-1% and is a major staple of the worldwide diet. Wheat avoidance is exceedingly difficult and imposes major dietary restriction. The purpose of this study were to determine the rate of oral tolerance and identify clinical and laboratory predictors of tolerance development in Thai children who allergic to wheat.
Read the detailed description
All children in this study were sensitized to wheat. Each patient was clinically evaluated, with focus on wheat allergy by both a detailed medical examination and collection of medical history. Blood sample was taken for baseline determination of ImmunoglobulinE antibodies to wheat and to omega-5-gliadin. The oral wheat challenge were performed in all study subjects to identify a case of wheat outgrowing. The primary outcome was the development of oral tolerance to wheat. Oral wheat challenge were generally performed at least every 1 years if the child did not have an interval history of symptoms with unintentional exposure.
- Conditions
- Wheat Allergy, Child
- Being tested
- oral wheat challenge
- Keywords
- wheat allergy, wheat outgrowing, wheat hypersensitivity, omega-5-gliadin, natural history of wheat hypersensitivity
- Medical subject headings
- Wheat Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral wheat challengeDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| oral wheat challenge | Experimental | Not described Receives: Dietary Supplement: oral wheat challenge |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of participants who outgrow from wheat allergy
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2013 (estimated)
- Study startNov 2012
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 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
- NCT01801748
- Sponsor's protocol ID
- 490/2555(EC3)
- Status last verified
- Apr 2015
- First submitted
- 26 Feb 2013
- Last updated
- 9 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Natural History of Wheat Hypersensitivity in Thai Children
- ClinicalTrials.gov ID
- NCT01801748
- Acronym / sponsor ID
- 490/2555(EC3)
- Conditions
- Wheat Allergy, Child
- Keywords
- wheat allergy, wheat outgrowing, wheat hypersensitivity, omega-5-gliadin, natural history of wheat hypersensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Collaborators
- National Research Council of Thailand
- Study start
- Nov 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 1 Mar 2013 (estimated)
- 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 affected 0.4-1% and is a major staple of the worldwide diet. Wheat avoidance is exceedingly difficult and imposes major dietary restriction. The purpose of this study were to determine the rate of oral tolerance and identify clinical and laboratory predictors of tolerance development in Thai children who allergic to wheat.
Detailed description
All children in this study were sensitized to wheat. Each patient was clinically evaluated, with focus on wheat allergy by both a detailed medical examination and collection of medical history. Blood sample was taken for baseline determination of ImmunoglobulinE antibodies to wheat and to omega-5-gliadin. The oral wheat challenge were performed in all study subjects to identify a case of wheat outgrowing. The primary outcome was the development of oral tolerance to wheat. Oral wheat challenge were generally performed at least every 1 years if the child did not have an interval history of symptoms with unintentional exposure.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| oral wheat challenge | Experimental | Dietary Supplement: oral wheat challenge |
Who may qualify
- Ages
- 1 year to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- children 1 to 15 years
- History of IgE-mediated wheat allergy
Key exclusion criteria (2 listed)
- Parents refused to sign the consent
- Patient has the underlying disease: congenital heart disease, uncontrolled asthma or life-threatening condition.
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 |
|---|---|---|
| oral wheat challenge | Dietary supplement | oral wheat challenge |
Primary outcome
The number of participants who outgrow from wheat allergy
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2015.
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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 oral wheat challenge in people with Wheat Allergy and Child, 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 2 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: finished, as of the sponsor's last update on 9 Apr 2015. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The number of participants who outgrow from wheat allergy (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Apr 2015.