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临床试验/NCT04190511
NCT04190511已完成不适用

Characteristic and Modulation of Gut Microbiota on the Consequences of Pregnancy-based on the Maternal and Offspring Health Cohort

Capital Medical University1 个研究点 分布在 1 个国家目标入组 375 人开始时间: 2019年12月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
375
试验地点
1
主要终点
The incidence of gestational diabetes mellitus

研究概览

简要总结

Since the incidence of maternal obesity and gestational diabetes mellitus (GDM) is on the rise globally, how to improve the intrauterine environment of the offspring and prevent obesity and metabolic diseases from the early life has become a medical research. Since 2012, journals such as Nature and Science have reported that intestinal micro-ecological environments composed of intestinal microbes and their interactions are involved in human body and energy metabolism, and a variety of metabolic diseases including obesity and type 2 diabetes mellitus (T2DM). The incidence is closely related. Although intestinal microbes have an important impact on human health, the research on intestinal microecology during pregnancy is still in its infancy. The current research is still unclear about the relationship between intestinal microecology and pregnancy outcomes and whether it can be a potential target for regulating maternal metabolism and fetal intrauterine environment. Therefore, this study aims to regulate overweight/obese pregnant women by using prebiotic-containing dairy products to explore the effects of interventions targeting intestinal microbes on glucose and lipid metabolism, insulin resistance and risk of GDM in overweight/obese pregnant women. In order to improve the intrauterine environment and reduce the risk of fetal diseases. It is of great significance and value to improve the quality of the birth population in China and to alleviate the medical economic burden caused by obesity and metabolic diseases.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

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

  • Age 18 ~ 45 years
  • single pregnancy
  • enrollment week 8-12 + 6 weeks (based on the last menstrual period or B-ultrasound monitoring)
  • BMI ≥ 25 kg / m2
  • living in Beijing for at least 5 years

排除标准

  • Taking antibiotics, probiotics or prebiotics
  • smoking regularly
  • drinking alcohol
  • assisted fertility technology conception
  • mental illness who were unable to answer questions correctly or were unwilling to conduct questionnaire surveys
  • history of bariatric surgery
  • not following dietary recommendations
  • Lactose intolerance
  • milk protein allergy
  • pre-pregnancy hypertension, diabetes, Hyperlipidemia, hepatitis, nephritis, gastrointestinal diseases (chronic gastritis, enteritis, gastric ulcer and duodenal ulcer, etc.) and a history of infectious diseases (hepatitis, tuberculosis, etc.).

结局指标

主要结局

The incidence of gestational diabetes mellitus

时间窗: Up to 28 weeks

The diagnose of GDM based on the result of OGTT according to IADPSG criterion in 24 to 28 weeks. We will compare the incidence of GDM in these three groups.

Weight change during pregnancy

时间窗: During pregnancy, an average of 38 weeks

We asked pregnant woman to weigh their weight using the same weighing scale in the morning of the inspection day after urinating and tell the obstetrician to record. Compare the weight gain during pregnancy among three groups.

次要结局

未报告次要终点

研究者

发起方
Capital Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Guanghui Li

Professor, MD, PhD

Capital Medical University

研究点 (1)

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