- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05670262
The Roles of Human Microbiome and Vitamin D in the Development of Childhood Allergic Diseases
Study Overview
Status
Conditions
Detailed Description
Allergic diseases are chronic inflammatory disorders that frequently affect young infants before one year of age, and is the beginning of allergy march in later life. The prevalence is increasing in industrial world, Taiwan included. Genetic and environmental factors, such exposure to allergens and microbes, especially early in life, have a detrimental role in the development of allergic diseases, such as atopic dermatitis (AD), allergic rhinitis and asthma. Vitamin D has an important role in different allergic disease. Lower cord blood vitamin D status was observed in infants that developed eczema. Vitamin D binding protein (DBP) bound to vitamin D and regulated its metabolites in the circulation. Moreover, vitamin D receptors have been identified on nearly all cells of the immune system. It may contribute to maintenance of intestinal barrier function by preventing increased intestinal permeability, dysbiosis, inflammation, and a lack of immune tolerance in the gut.
Although aberrant interactions between gut microbes and the intestinal immune system have been implicated in this allergic disease, however, the causal effect of microbiota colonization of the gut and vitamin D that influence the development of allergic diseases, such as AD, in young infants is still unknown. The investigators plan to design 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.
In this study, the investigators will recruit mother-infant pairs in antenatal clinics in China Medical University Hospital and China Medical University Children's Hospital. Newborns who have been enrolled at birth are collected for meconium samples before discharged from nursery and eligible for follow-up visits, and collect their nasal and anal swab microbiome samples at 2 and 12 months follow-up visit. Parental questionnaires are collected at 6, and 12 months of age. All infants were assessed at birth, 2 and 6, and 12 months of age. Assessment included physical examination for allergic diseases. In addition, infants at 12 months of age were collected their 3cc of blood sample.
The investigators believe this longitudinal and prospective study, to follow-up infants from the date of birth until one years old, can answer the cause-effect relationships of microbiota and vitamin D in the development of allergic diseases, and design a microbiota-related preventive and treatment strategy.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Jiu-Yao Wang, MD
- Phone Number: 4131 886422052121
- Email: aim.cmuh@gmail.com
Study Locations
-
-
-
Taichung, Taiwan, 404
- Recruiting
- China Medical University Hospital
-
Contact:
- Jiu-Yao Wang, MD
- Phone Number: 4131 886422052121
- Email: aim.cmuh@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion 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.
Exclusion Criteria:
- The exclusion criteria are prematurity newborn, congenital anomalies and cardiopulmonary failure need for resuscitation immediately after birth.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Microbiome
Time Frame: Month 0
|
Meconium samples will be used to detect intestinal microbiome by using 16S rRNA sequencing to determine baseline status.
|
Month 0
|
Microbiome
Time Frame: Month 2
|
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
Time Frame: Month 12
|
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
Time Frame: Month 12
|
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
Time Frame: Month 12
|
Single nucleotide polymorphism (SNP) genotyping will be performed in a blood sample by using TaqMan SNP genotyping assays.
|
Month 12
|
Total immunoglobulin E (IgE)
Time Frame: Month 12
|
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)
Time Frame: Month 12
|
Plasma allergen-specific IgE will be measured by BioIC ®.
|
Month 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Parental questionnaire (0-6 month)
Time Frame: Month 6
|
For assessing child's health, feeding habit, and environmental exposure
|
Month 6
|
Parental questionnaire (6-12 month)
Time Frame: Month 12
|
For assessing child's health, feeding habit, and environmental exposure
|
Month 12
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CMUH111-REC2-033
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pediatric
-
National Institute of Allergy and Infectious Diseases...Clinical Trials in Organ Transplantation in ChildrenCompletedPediatric Heart Transplantation | Pediatric Heart Transplant Recipients | Pediatric Cardiac TransplantationUnited States
-
Samsung Medical CenterMinistry of Health, Republic of KoreaRecruitingRelapsed Pediatric AML | Refractory Pediatric AML | Relapsed Pediatric Solid Tumor | Refractory Pediatric Solid TumorKorea, Republic of
-
University Hospital, Strasbourg, FranceTerminatedPediatric Lung Ultrasound | Pediatric Chest Radiography | Pediatric Lung DiagnosisFrance
-
University of BirminghamCompletedCancer | Pediatric ALL | Pediatric Solid Tumor | Pediatric AMLUnited Kingdom, Australia, Netherlands
-
National Institute of Allergy and Infectious Diseases...National Heart, Lung, and Blood Institute (NHLBI)TerminatedPediatric Heart Transplantation | Pediatric Heart Transplant RecipientsUnited States, Canada
-
TC Erciyes UniversityCompletedPediatric Cancer | Pediatric Brain Tumor | Pediatric Solid TumorTurkey
-
Hospital Moinhos de VentoNot yet recruitingAdolescent | Telemedicine | Critical Care | Pediatric | Intensive Care Units, Pediatric
-
Samsung Medical CenterMinistry of Health, Republic of KoreaNot yet recruitingRelapsed Pediatric Solid Tumor | Refractory Pediatric Solid TumorKorea, Republic of
-
University of CalgaryCanadian Institutes of Health Research (CIHR); Alberta Children's Hospital; Stollery... and other collaboratorsNot yet recruitingPediatric Cancer | Pediatric Hematology
-
National Taiwan University HospitalUnknownPalliative Care | Pediatric Cancer | Nursing Caries | Oncology | Pediatric PopulationTaiwan