The Effects of Intrapartum Antibiotic Prophylaxis to Prevent Group B Streptococcal Early-onset Disease on Intestinal Microbiome and Immunity of Offspring
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Intestinal flora
研究概览
简要总结
This study is planned to be recruited in two hospitals in South China, Zhujiang Hospital of Southern Medical University and Zhongshan Boai Hospital Recruit participants, plan to recruit obstetrics and child health departments in study hospitals, meet inclusion and discharge criteria 1~3 infants, a total of 360, recruited by Pearl River Hospital of Southern Medical University and Zhongshan Boai Hospital 180 people each.
详细描述
This is a case-control study. By collecting fecal samples of infants and young children in the observation group and control group at different time points (0~1 years old, 1~2 years old, 2~3 years old), the intestinal flora of infants and young children was detected by 16S rDNA sequencing, and fecal calprotectin (CP) and secretory IgA (SIgA) were detected by ELISA. To study the effects of exposure factors on intestinal flora and immunity in offspring.
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
- 37 Weeks 至 41 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants:37-41 weeks of age, born through vaginal delivery, 2500g<= birth weight < 4000g,0-3 years of age;
- •The mother: birth ranging in age from 18 to 40 years old, the single pregnancy, pregnancy 35 -41 weeks to complete the GBS screening;
- •The guardian agrees to participate in the study voluntarily.
排除标准
- •Infants and children with serious congenital abnormalities, infections or clinical diseases;
- •Antibiotics should be used in infants within 2 weeks, probiotics, prebiotics and biostime should be supplemented, or long-term drug treatment should be given for digestive, immune, blood and other diseases;
- •Infant mothers: childbirth after long-term drug treatment due to digestive, immune, blood and chronic diseases during pregnancy; Or infants who were breastfed within 12 hours of antibiotic use after delivery;
- •Any medical or non-medical condition that the investigator deems inappropriate to participate in.
研究组 & 干预措施
Reproductive tract GBS colonization group of mothers during pregnancy
Reproductive tract GBS colonization group of mothers during pregnancy，Use of antibiotics
干预措施: antibiotics (Drug)
结局指标
主要结局
Intestinal flora
时间窗: Fecal samples of infants and young children in the observation group and control group at different time points (0~1 years old) of offspring were collected
Analyze the effect of intrapartum antibiotics on the prevention of early-onset group B streptococcal diseases on the gut microbiome.
Secretory IgA
时间窗: Fecal samples of infants and young children in the observation group and control group at different time points (0~1 years old) of offspring were collected
Analyze the effect of intrapartum antibiotics on the prevention of early-onset group B streptococcal diseases on the secretory IgA of offspring.
Calprotectin
时间窗: Fecal samples of infants and young children in the observation group and control group at different time points (0~1 years old) of offspring were collected
Analyze the effect of intrapartum antibiotics on the prevention of early-onset group B streptococcal diseases on the cailprotectin of offspring.
次要结局
- Intestinal flora(Fecal samples of infants and young children in the observation group and control group at different time points 1~2 years of offspring were collected)
- Secretory IgA(Fecal samples of infants and young children in the observation group and control group at different time points 1~2 years of offspring were collected)
- Calprotectin(Fecal samples of infants and young children in the observation group and control group at different time points 1~2 years of offspring were collected)