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临床试验/NCT04277260
NCT04277260Unknown不适用

Study on the Molecular Structure and Content of Human Milk Oligosaccharides (HMOs) in Breast Milk and Its Effect on Infant Health in China

Heilongjiang Feihe Dairy Co. Ltd.1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2019年4月8日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
120
试验地点
1
主要终点
Human milk oligosaccharide detection

研究概览

简要总结

In the study, the composition and content of human milk oligosaccharides in premature delivery mothers in China will be examined to investigate the differences in oligosaccharide concentrations in preterm breast milk from different gestational weeks. This study will fill a gap in human milk research in China, provide theoretical basis for the superiority of breastfeeding, and provide more powerful nutritional support for the catch-up growth of preterm infants

详细描述

Objective

  1. Analyze and compare the differences in HMOs components among mothers who give birth at different gestational weeks;
  2. Longitudinal observation of weekly changes in HMOs concentrations of premature mothers within 1 month of delivery;
  3. Validate the association between HMOs components in preterm mothers and fecal intestinal flora in infants at 6 months of age.

Research content

  1. The LC-MS method will be used to detect the content of HMOs in preterm mothers and compared with the corresponding components in term breast milk during the postpartum period to analyze the effects of different gestational weeks on HMOs;
  2. The intestinal flora 16S rDNA high-throughput sequencing method will be used to determine the bacterial gene profile in the fecal DNA samples of infants, and the differences between the gestational age groups (term and preterm infants) were compared, and the preterm infants in this group were plotted Evolution of intestinal flora within 6 months of birth;
  3. Use statistical methods to verify the association between HMOs components in preterm mothers and the establishment of intestinal flora in infants.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Other

入排标准

年龄范围
7 Days 至 35 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • (1) Be healthy, have no acute or chronic diseases, have no severe complications during pregnancy
  • (2) Breastfeeding for more than 6 months and Volunteer to participate in this study (signed informed consent)
  • (3) Age of maternal women: 20~35years
  • (4) Breast milk is sufficient, and the amount of milk secreted each time is more than 30ml
  • (5) No fatal, important organ system deformities and metabolic defects in neonates

排除标准

  • (1) for infants: Rescued to death or hospitalized due to critical illness during the study period
  • (2)for lactating mothers: exposure to tobacco and alcohol during lactation, severe postpartum depression and other mental and psychological diseases, obesity (BMI> 28), use of antibiotics or antimetabolites, mastitis with fever within 7 days before specimen collection (T> 38.5 ℃),Suspension or termination of breastfeeding in the state of maternal and infant illness

结局指标

主要结局

Human milk oligosaccharide detection

时间窗: Day7-12, Day14-19, Day21-26, Day28-33

Liquid chromatography-mass spectrometer(LC-MS) will be used to quantitatively detect a total of 15 types of neutral oligosaccharides and acid oligosaccharides in different breast milk samples. Human milk samples will be collected four times for each mother after delivery (day7-12, day14-19, day21-26, day28-33). Only one series of samples will be collected for each mother, and 30 samples are needed for each group, totaling 480 human milk samples

次要结局

  • Disease and medication history(6 months)
  • Achieved the body weight of infants(Day7-12, Day14-19, Day21-26, Day28-33, 2 months, 3 months, 4months and 6 months.)
  • Achieved the body length of infants(Day7-12, Day14-19, Day21-26, Day28-33, 2 months, 3 months, 4months and 6 months.)
  • Achieved the head circumference of infants(Day7-12, Day14-19, Day21-26, Day28-33, 2 months, 3 months, 4months and 6 months.)
  • To dectect the intestinal flora with16s RNA high throughput sequencing(Day7-12, Day28-33, 3 months and 6 months)
  • Average daily formula intake(Day7-12, Day14-19, Day21-26, Day28-33, 2 months, 3 months, 4months and 6 months.)
  • Stool status of infants(Day7-12, Day14-19, Day21-26, Day28-33, 2 months, 3 months, 4months and 6 months.)

研究者

发起方
Heilongjiang Feihe Dairy Co. Ltd.
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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