Omics Sequencing of Specimen Derived From Mother-Infant-Pairs
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Compare the omics differences of the specimens between the experimental and control groups
研究概览
简要总结
The investigators aim to collect breast-milk and feces from the participants, and apply culture techniques as well as omics sequencing technology to probe into the microbial and metabolomic signature of the specimens.
研究设计
- 研究类型
- Observational
- 观察模型
- Family Based
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy pregnant women aged between 20y and 40y.
- •Vaginal birth
- •BMI<23.5 before pregnancy
- •Infants' birth weight, between 2500g and 4000g.
排除标准
- •gestational diabetes
- •diagnosis of depressive disorder during pregnancy
- •gestational hypertension
- •diagnosis of other diseases during pregnancy
- •Under probiotics or antibiotic treatment from 3 months prior to pregnancy till 3 months after delivery
- •histrory of smoking and drinking alcohol
- •history of diarrhea from 3 months prior to pregnancy till 3 months after delivery
结局指标
主要结局
Compare the omics differences of the specimens between the experimental and control groups
时间窗: 2021.7.1-2026.12.30
Apply 16S amplicon sequencing and shotgun sequencing technology to obtain microbial structure of the specimens. The differences of microbial structure will be compared between the experimental and control groups. Significance among multiple groups was tested using a one-way analysis of variance (ANOVA), followed by the least significant difference (LSD) post hoc test. Groups with different characters denoting a significant difference, while having the same character denotes p-value \> 0.05 in LSD test.
Compare the microbial feature differences of the specimens between the experimental and control groups
时间窗: 2021.7.1-2026.12.30
Apply traditional culture technologies to validate and obtain human source bacteria.The differences of frequencies of probiotics will be compared between the experimental and control groups. Depending on the distribution of the variables, either the Mann-Whitney test or the unpaired Student's t-test was employed for quantitative variables. The Kruskal-Wallis test for mean values was used to evaluate non-parametric comparisons between participants in all groups. Significance among multiple groups was tested using a one-way analysis of variance (ANOVA), followed by the least significant difference (LSD) post hoc test. Groups with different characters denoting a significant difference, while having the same character denotes p-value \> 0.05 in LSD test.
次要结局
- Compare the health status differences between the experimental and control groups(2021.7.1-2026.12.30)
研究者
Ma Ying
Clinical Professor
Zhujiang Hospital