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临床试验/NCT04919265
NCT04919265招募中不适用

Breastmilk, Infant Gut Microbiome and the Impact on Infant Health: a Prospective Mother-Infant Cohort Study in Malaysia and China

Universiti Putra Malaysia1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2022年6月3日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
1
主要终点
Breastmilk microbiome

研究概览

简要总结

This mother-infant cohort study aims to determine the geographic differences in the microbial profiles in breast milk from mothers living in Malaysia and China that are potentially important determinants of infant development. It also aims to determine the impact of gut microbiome on infant health (temperament, gastrointestinal symptoms, eczema symptoms, and asthma symptoms).

详细描述

Gut microbiota plays a critical role in children's developmental pathways especially in the first 1000 days of life. A number of pre- and post-natal factors were known to affect gut microbiota in infants during their first year of life including mode of delivery, infant feeding practices, dietary intake, and human milk composition. However, there is no mother-infant cohort study comparing gut microbiota profile and breastmilk composition of mothers living in Malaysia and China. Recent studies showed that gut microbiota was associated with infant health including temperament, gastrointestinal disorders, eczema, and asthma. However, little is known about the gut microbiome and the factors that contribute to microbial variation in the gut of South East Asian children. Increased awareness on the importance of gut health helps establish pre-natal and post-natal factors that promote healthy development and functioning of immune system, gastrointestinal health, and metabolism in infants.

This study is a prospective cohort study involving pregnant women in the first trimester of pregnancy. Data will be collected from the eligible pregnant women during their first trimester (8-12 weeks of gestation), second trimester (24 weeks of gestation), third trimester (34 weeks of gestation) and follow-up infants and mothers postnatally after birth (1-5 days after delivery), at 10-15 days, 1 month, 4 months and 12 months of age with a total of 8 follow-ups of mother-infant biological samples and related research data.

Mothers will be interviewed on socio-demographic background and information on pre-natal and post-natal factors such as obstetric history, exposure to antibiotics/prebiotics/probiotics/ paracetamol, pre-pregnancy body BMI, gestational weight gain, GDM, physical activity, food security, smoking during pregnancy/second-hand exposure, dietary intake, stress during pregnancy, home settings, pet keeping, and post-natal depression. Mothers will also be interviewed on their infants' sex, birth order, gestational age, mode of delivery, body weight, length, and head circumferences, second hand smoke exposure, exposure to antibiotics/prebiotics/probiotics/paracetamol, infant feeding practices, dietary intake, and dietary diversity. Anthropometric measurements of mothers and infants will be conducted at every visit. Blood, fecal, saliva, and urine samples of mothers and infants will also be collected. All bio-specimens are stored at -80°C until they are transported to National Engineering Center of Dairy for Maternal and Child Health, Beijing, China for further analysis.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant women aged between 18 and 45 years old
  • Pregnant women who attend the antenatal check-up at the selected clinics/hospitals
  • Pregnant women with the gestational age of less than 12 weeks
  • Pregnant women who plan to attend post-natal check-ups for at least one year at the same clinic/hospital

排除标准

  • Pregnant women who are diagnosed with immune deficiency
  • Pregnant women who have a multiple pregnancy and preterm delivery (<37 weeks)
  • Pregnant women who plan to move out of the study area in the next one year
  • Pregnant women with fetal/newborn with congenital abnormalities

结局指标

主要结局

Breastmilk microbiome

时间窗: from birth to 12 months

Breastmilk microbiota composition is determined by using 16S rRNA gene sequencing

Gut microbiome

时间窗: from birth to 12 months

Gut microbiome diversity profile is analysed from the stool by using qPCR and sequencing approaches analysis

次要结局

  • Infant weight(from birth to 12 months)
  • Temperament(12 months)
  • Gastrointestinal symptoms(from birth to 12 months)
  • Eczema symptoms(from birth to 12 months)
  • Asthma symptoms(from birth to 12 months)
  • Infant diet(from birth to 12 months)
  • Infant height(from birth to 12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gan Wan Ying

Assoc. Prof. Dr.

Universiti Putra Malaysia

研究点 (1)

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