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Comparative Study of Specific IgE Levels to Common Foods and Aeroallergens Measured by EUROIMMUN Allergy and ImmunoCap

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ClinicalTrials.gov Identifier: NCT02328170
Recruitment Status : Completed
First Posted : December 31, 2014
Last Update Posted : March 22, 2017
Sponsor:
Information provided by (Responsible Party):
JITTIMA VESKITKUL, Mahidol University

Tracking Information
First Submitted Date December 11, 2014
First Posted Date December 31, 2014
Last Update Posted Date March 22, 2017
Actual Study Start Date May 2014
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 26, 2014)
specific IgE levels measured by EUROIMMUN Allergy and ImmunoCap [ Time Frame: 14 months ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Comparative Study of Specific IgE Levels to Common Foods and Aeroallergens Measured by EUROIMMUN Allergy and ImmunoCap
Official Title Comparative Study of Specific IgE Levels to Common Foods and Aeroallergens Among Thai Children Measured by EUROIMMUN Allergy and ImmunoCap
Brief 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
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Clotted blood 3 mL
Sampling Method Non-Probability Sample
Study Population Patients who was diagnosed as having asthma and/or allergic rhinitis and/or atopic dermatitis and/or food allergy, were enrolled.
Condition Allergy
Intervention
  • Other: EUROIMMUN Allergy
    Immunoblot assay
  • Other: ImmunoCap
    Fluoroallergosorbent test
Study Groups/Cohorts
  • EUROIMMUN Allergy
    Immunoblot assay
    Intervention: Other: EUROIMMUN Allergy
  • ImmunoCap
    Fluoroallergosorbent test
    Intervention: Other: ImmunoCap
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 26, 2014)
235
Original Estimated Enrollment Same as current
Actual Study Completion Date February 2017
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Having underlying disease including cardiovascular disease, chronic lung disease and immunodeficiency disease
  • Denied to enrolled to the study
Sex/Gender
Sexes Eligible for Study: All
Ages up to 15 Years   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Thailand
Removed Location Countries  
 
Administrative Information
NCT Number NCT02328170
Other Study ID Numbers 054/2557(EC2)
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party JITTIMA VESKITKUL, Mahidol University
Study Sponsor Mahidol University
Collaborators Not Provided
Investigators
Principal Investigator: Jittima Veskitkul, Assist Prof. Mahidol University
PRS Account Mahidol University
Verification Date March 2017