Integrative Approach to Identify Environmental Risk Factors for CC-17 Group B Streptococcal Neonatal Infection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 151
- 试验地点
- 1
- 主要终点
- Number of Negative GBS screening in vaginal samples
研究概览
简要总结
Streptococcus agalactiae (GBS) is the leading cause of neonatal septicaemia, meningitis, and pneumonia in the industrialized world. Early onset (EOD) and late onset (LOD) diseases are defined in neonates by their occurring within or after the first week of life, respectively. Molecular epidemiological studies have identified a capsular serotype III clone, referred to as CC-17 by Multi Locus Sequence Typing, as accounting for the vast majority of neonatal invasive diseases and for almost all cases of meningitis in LOD.
The investigators working hypothesis is that host-environmental interactions may contribute to the colonization and persistence of the hypervirulent CC-17 GBS in the neonate. In this project the investigators will determine if reciprocal interactions between the intestinal microbiota and the innate and adaptive immune system may specifically facilitate the colonization of the neonate by the hypervirulent GBS CC-17 clone.
详细描述
Four specific tasks will be addressed to:
(i) Understand whether and how the gut microbiota may influence growth and colonization of GBS CC-17 within the intestine of neonates.
(ii) Study the contribution of different diets and immune system constituents enabling the persistence of GBS CC-17 in the gut of neonates.
(iii) Determine whether the adaptive immune response elicited by maternal GBS colonization and transmitted to the infant is different for GBS CC-17 versus non-CC-17 GBS.
(iv) Determine whether or not GBS strains isolated from the mothers and from their babies are identical and whether the environment (ie. the vagina or the milk for the mother, the intestine or the oral cavity for the baby) influence the expression of specific virulence factors of CC-17.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Pregnant women negative for GBS colonization
Only women negative for GBS during all the study will be included.
干预措施: Bacteriological analyses on clinical samples performed with Eswabs (Biological)
结局指标
主要结局
Number of Negative GBS screening in vaginal samples
时间窗: 2 months
次要结局
- Number of Negative GBS screening in fecal samples .(at birth)
- Number of Negative GBS screening in vaginal samples(At delivery)