Integrative Approach to Identify Environmental Risk Factors for CC-17 Group B Streptococcal Neonatal Infection

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Integrative Approach to Identify Environmental Risk Factors for CC-17 Group B Streptococcal Neonatal Infection

Conditions
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Vaginal Colonization With GBS

Intervention / Treatment
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* Biological: Bacteriological analyses on clinical samples performed with Eswabs


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Patient having a negative vaginal swab for GBS at 35-37 weeks Patient aged over 18 years Patient who received information and agreeing to sign informed consent Patient affiliated or beneficiary of an insurance Exclusion criteria: Patient does not speak and does not understand French

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pregnant women negative for GBS colonization<br>Only women negative for GBS during all the study will be included. | Biological: Bacteriological analyses on clinical samples performed with Eswabs<br>* Clinical samples analysed : mothervagina, breast milk, baby oral cavity, baby stool. Techniques: bacteriological cultures, Real time PCR<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Negative GBS screening in vaginal samples |  | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Negative GBS screening in fecal samples . |  | 2 months | 
| Number of Negative GBS screening in fecal samples . |  | at birth | 
| Number of Negative GBS screening in vaginal samples |  | At delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Streptococcus agalactiae, Group B Streptococcus, Neonates, colonization, meningitis, Clonal Complex CC17, microbiota, next generation sequencing (NGS)