The Roles of Human Microbiome and Vitamin D in the Development of Childhood Allergic Diseases
1 other identifier
observational
6,000
1 country
1
Brief Summary
A birth cohort study to evaluate the role of human microbiome and vitamin D in the development of allergic diseases in young child before one year of age.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2022
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 4, 2022
CompletedFirst Submitted
Initial submission to the registry
January 2, 2023
CompletedFirst Posted
Study publicly available on registry
January 4, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2027
February 7, 2024
February 1, 2024
5 years
January 2, 2023
February 5, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
Microbiome
Meconium samples will be used to detect intestinal microbiome by using 16S rRNA sequencing to determine baseline status.
Month 0
Microbiome
Nasal and anal swabs will be used to detect respiratory and intestinal microbiome by using 16S rRNA sequencing to determine baseline status.
Month 2
Microbiome
Nasal and anal swabs will be used to detect respiratory and intestinal microbiome by using 16S rRNA sequencing,and to follow the change from baseline in microbiome at month 12.
Month 12
Levels of vitamin D
Vitamin D will be measured in a blood sample by ELISA.
Month 12
Single nucleotide polymorphism of vitamin D receptor and vitamin D binding protein
Single nucleotide polymorphism (SNP) genotyping will be performed in a blood sample by using TaqMan SNP genotyping assays.
Month 12
Total immunoglobulin E (IgE)
Plasma total IgE concentration will be measured by microparticle immunoassay (IMx analyzer, Abbott Laboratories, Abbott Park, IL) and ELISA.
Month 12
Allergen-specific immunoglobulin E (IgE)
Plasma allergen-specific IgE will be measured by BioIC ®.
Month 12
Secondary Outcomes (2)
Parental questionnaire (0-6 month)
Month 6
Parental questionnaire (6-12 month)
Month 12
Eligibility Criteria
All term newborn babies who are born in China Medical University Hospital. The term baby defines the maternal gestational age between 37 0/7 weeks to 41 6/7 weeks.
You may qualify if:
- All term newborn babies who are born in China Medical University Hospital. The term baby defines the maternal gestational age between 37 0/7 weeks to 41 6/7 weeks.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
China Medical University Hospital
Taichung, 404, Taiwan
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 2, 2023
First Posted
January 4, 2023
Study Start
August 4, 2022
Primary Completion (Estimated)
July 31, 2027
Study Completion (Estimated)
July 31, 2027
Last Updated
February 7, 2024
Record last verified: 2024-02