AllergyNCT02328170
Comparative Study of Specific IgE Levels to Common Foods and Aeroallergens Measured by EUROIMMUN Allergy and ImmunoCap
An observational study of Allergy, run by Mahidol University at 1 site in Thailand.
Trial summary
The purpose of this study is to determine the correlation of specific IgE levels to common foods and aeroallergens measured by EUROIMMUN Allergy and ImmunoCap Read more about this study
- Who is it for?
- Ages Up to 15 years
- Conditions the study is for
- Allergy
- What is being tested?
- EUROIMMUN Allergy and ImmunoCap
- How many people
- 235 participants
- Where
- 1 siteThailand
- Study dates
- May 2014to Feb 2017
- Phase
- Observational
- 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 Up to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: Patients who was diagnosed as having asthma and/or allergic rhinitis and/or atopic dermatitis and/or food allergy, were enrolled.
Who may be able to join
- Clinical diagnosed as asthma and/or allergic rhinitis and/or atopic dermatitis and/or food allergy and have to measured specific IgE levels to relevant allergens
Who cannot join
- Having underlying disease including cardiovascular disease, chronic lung disease and immunodeficiency disease
- Denied to enrolled to the study
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Division of Allergy and Immunology, Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, Bangkok, 10700
About this study
Official title: Comparative Study of Specific IgE Levels to Common Foods and Aeroallergens Among Thai Children Measured by EUROIMMUN Allergy and ImmunoCap
The purpose of this study is to determine the correlation of specific IgE levels to common foods and aeroallergens measured by EUROIMMUN Allergy and ImmunoCap
Read the detailed description
Children aged 0-15 years old who was diagnosed as asthma and/or allergic rhinitis, atopic dermatitis, food allergy, and underwent to measured specific IgE levels to suspicious relevant allergen, were invited to join the study.
Specific IgE levels of each patient was measured by EUROIMMUN Allergy and ImmunoCap.
The levels of specific IgE to Dermatophagoides pteronyssinus, Dermatophagoides farinae, American cockroach, Bermuda, Johnson, Cat dander, Cow's milk, Egg white and wheat were determined the correlation between these two methods.
- Conditions
- Allergy
- Being tested
- EUROIMMUN Allergy, ImmunoCap
- Keywords
- immunoglobulin E, food hypersensitivities, child, allergens
- Medical subject headings
- Hypersensitivity, Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EUROIMMUN AllergyOther
Immunoblot assay
ImmunoCapOther
Fluoroallergosorbent test
| Study group | Role | What they receive |
|---|---|---|
| EUROIMMUN Allergy | Immunoblot assay Receives: Other: EUROIMMUN Allergy | |
| ImmunoCap | Fluoroallergosorbent test Receives: Other: ImmunoCap |
What is being measured
The primary outcome is the main question the study is designed to answer.
specific IgE levels measured by EUROIMMUN Allergy and ImmunoCap
Measured: 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2014 (estimated)
- Study startMay 2014
- Primary completionAug 2016
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 235 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JITTIMA VESKITKUL, Mahidol University
- Investigators
- Jittima Veskitkul, Assist Prof., Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02328170
- Sponsor's protocol ID
- 054/2557(EC2)
- Status last verified
- Mar 2017
- First submitted
- 11 Dec 2014
- Last updated
- 22 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Specific IgE Levels to Common Foods and Aeroallergens Among Thai Children Measured by EUROIMMUN Allergy and ImmunoCap
- ClinicalTrials.gov ID
- NCT02328170
- Acronym / sponsor ID
- 054/2557(EC2)
- Conditions
- Allergy
- Keywords
- immunoglobulin E, food hypersensitivities, child, allergens
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 235 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- May 2014 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 31 Dec 2014 (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.
The purpose of this study is to determine the correlation of specific IgE levels to common foods and aeroallergens measured by EUROIMMUN Allergy and ImmunoCap
Detailed description
Children aged 0-15 years old who was diagnosed as asthma and/or allergic rhinitis, atopic dermatitis, food allergy, and underwent to measured specific IgE levels to suspicious relevant allergen, were invited to join the study.
Specific IgE levels of each patient was measured by EUROIMMUN Allergy and ImmunoCap.
The levels of specific IgE to Dermatophagoides pteronyssinus, Dermatophagoides farinae, American cockroach, Bermuda, Johnson, Cat dander, Cow's milk, Egg white and wheat were determined the correlation between these two methods.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EUROIMMUN Allergy | – | Other: EUROIMMUN AllergyImmunoblot assay |
| ImmunoCap | – | Other: ImmunoCapFluoroallergosorbent test |
Who may qualify
- Ages
- Up to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients who was diagnosed as having asthma and/or allergic rhinitis and/or atopic dermatitis and/or food allergy, were enrolled.
Key inclusion criteria (1 listed)
- Clinical diagnosed as asthma and/or allergic rhinitis and/or atopic dermatitis and/or food allergy and have to measured specific IgE levels to relevant allergens
Key exclusion criteria (2 listed)
- Having underlying disease including cardiovascular disease, chronic lung disease and immunodeficiency disease
- Denied to enrolled to the study
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 |
|---|---|---|
| EUROIMMUN AllergyImmunoblot assay | Other | EUROIMMUN Allergy |
| ImmunoCapFluoroallergosorbent test | Other | ImmunoCap |
Primary outcome
specific IgE levels measured by EUROIMMUN Allergy and ImmunoCap
Time frame: 14 months
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 22 Mar 2017.
- Individual participant dataSharing planned: No
Related trials for Allergy
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
Jittima Veskitkul, Assist Prof. 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?
An observational study of Allergy, 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 1 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 22 Mar 2017. 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?
specific IgE levels measured by EUROIMMUN Allergy and ImmunoCap (time frame: 14 months). 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 22 Mar 2017.