Clinical trial NCT05670262: The Roles of Human Microbiome and Vitamin D in the Development of Childhood Allergic Diseases
Official title: The Roles of Human Microbiome and Vitamin D in the Development of Childhood Allergic Diseases
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pediatric
Keywords: allergic diseases
birth cohort
human microbiome
vitamin D
vitamin D receptors and vitamin D binding protein
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2023-01-04
Enrollment: 6000
Sex: ALL
Minimum age (years): 0
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

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.

Eligibility 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.

Primary outcomes:
measure: Microbiome
timeFrame: Month 0
measure: Microbiome
timeFrame: Month 2
measure: Microbiome
timeFrame: Month 12
measure: Levels of vitamin D
timeFrame: Month 12
measure: Single nucleotide polymorphism of vitamin D receptor and vitamin D binding protein
timeFrame: Month 12
measure: Total immunoglobulin E (IgE)
timeFrame: Month 12
measure: Allergen-specific immunoglobulin E (IgE)
timeFrame: Month 12
Secondary outcomes:
measure: Parental questionnaire (0-6 month)
timeFrame: Month 6
measure: Parental questionnaire (6-12 month)
timeFrame: Month 12
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
Study officials:
References: