Идёт набор NCT05670262

The Roles of Human Microbiome and Vitamin D in the Development of Childhood Allergic Diseases

— Наблюдательное Pediatric

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально: Состояния в реестре: Pediatric. Базовые параметры: 0 лет — 1 год · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Тайвань
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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.

Подробное описание

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.

Первичные конечные точки

Microbiome [Срок оценки: Month 0]
Microbiome [Срок оценки: Month 2]
Microbiome [Срок оценки: Month 12]
Levels of vitamin D [Срок оценки: Month 12]
Single nucleotide polymorphism of vitamin D receptor and vitamin D binding protein [Срок оценки: Month 12]
Total immunoglobulin E (IgE) [Срок оценки: Month 12]
Allergen-specific immunoglobulin E (IgE) [Срок оценки: Month 12]

Вторичные конечные точки (2)

Parental questionnaire (0-6 month) [Срок оценки: Month 6]
Parental questionnaire (6-12 month) [Срок оценки: Month 12]

Критерии участия

Критерии включения

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.