Examining how gut bacteria and vitamin D affect allergic diseases in infants
The Roles of Human Microbiome and Vitamin D in the Development of Childhood Allergic Diseases
China Medical University Hospital · NCT05670262
This study is trying to see how gut bacteria and vitamin D levels affect the chances of infants developing allergic diseases like asthma and eczema in their first year of life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 6000 (estimated) |
| Ages | 0 Years to 1 Year |
| Sex | All |
| Sponsor | China Medical University Hospital (other) |
| Locations | 1 site (Taichung) |
| Trial ID | NCT05670262 on ClinicalTrials.gov |
What this trial studies
This observational birth cohort study aims to evaluate the influence of the human microbiome and vitamin D on the development of allergic diseases in infants under one year of age. It focuses on understanding how genetic and environmental factors, particularly early exposure to allergens and microbes, contribute to conditions like atopic dermatitis, allergic rhinitis, and asthma. The study will assess the relationship between vitamin D levels, vitamin D binding protein, and gut microbiota colonization in newborns. By analyzing these factors, the researchers hope to uncover the mechanisms behind the increasing prevalence of allergic diseases in young children.
Who should consider this trial
Good fit: Ideal candidates for this study are term newborn babies born at China Medical University Hospital.
Not a fit: Patients who are premature, have congenital anomalies, or require immediate resuscitation after birth may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved strategies for preventing allergic diseases in infants.
How similar studies have performed: While the role of the microbiome and vitamin D in allergic diseases has been explored, this specific birth cohort approach is relatively novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Taichung
- China Medical University Hospital — Taichung, Taiwan (RECRUITING)
Study contacts
- Study coordinator: Jiu-Yao Wang, MD
- Email: aim.cmuh@gmail.com
- Phone: 886422052121
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pediatric, allergic diseases, birth cohort, human microbiome, vitamin D, vitamin D receptors and vitamin D binding protein