This trial is active, not recruiting.

Condition vaginal colonization with gbs
Treatment bacteriological analyses on clinical samples performed with eswabs
Sponsor Assistance Publique - Hôpitaux de Paris
Start date April 2015
End date June 2016
Trial size 151 participants
Trial identifier NCT02471937, 2014-A01824-43


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose screening
Only women negative for GBS during all the study will be included.
bacteriological analyses on clinical samples performed with eswabs
Clinical samples analysed : mothervagina, breast milk, baby oral cavity, baby stool. Techniques: bacteriological cultures, Real time PCR

Primary Outcomes

Number of Negative GBS screening in vaginal samples
time frame: 2 months

Secondary Outcomes

Number of Negative GBS screening in fecal samples .
time frame: 2 months
Number of Negative GBS screening in fecal samples .
time frame: at birth
Number of Negative GBS screening in vaginal samples
time frame: At delivery

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title Integrative Approach to Identify Environmental Risk Factors for CC-17 Group B Streptococcal Neonatal Infection
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Assistance Publique - Hôpitaux de Paris.