Vaginal Colonization With GBSSTREPB17NCT02471937
Integrative Approach to Identify Environmental Risk Factors for CC-17 Group B Streptococcal Neonatal Infection
A study testing Bacteriological analyses on clinical samples performed with Eswabs in people with Vaginal Colonization With GBS, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vaginal Colonization With GBS
- What is being tested?
- Bacteriological analyses on clinical samples performed with Eswabs
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2015to 28 Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patient does not speak and does not understand French
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Conditions
- Vaginal Colonization With GBS
- Being tested
- Bacteriological analyses on clinical samples performed with Eswabs
- Keywords
- Streptococcus agalactiae, Group B Streptococcus, Neonates, colonization, meningitis, Clonal Complex CC17, microbiota, next generation sequencing (NGS)
- Medical subject headings
- Meningitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bacteriological analyses on clinical samples performed with EswabsBiological
Clinical samples analysed :
mothervagina, breast milk, baby oral cavity, baby stool. Techniques: bacteriological cultures, Real time PCR
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women negative for GBS colonization | Experimental | Only women negative for GBS during all the study will be included. Receives: Biological: Bacteriological analyses on clinical samples performed with Eswabs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Negative GBS screening in vaginal samples
Measured: 2 months
Secondary outcomes (3)
Number of Negative GBS screening in fecal samples .
Measured: 2 months
Number of Negative GBS screening in fecal samples .
Measured: at birth
Number of Negative GBS screening in vaginal samples
Measured: At delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2015 (estimated)
- Study start1 Jun 2015
- Primary completion28 Apr 2016
- Study completion28 Apr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vaginal Colonization With GBSStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Claire POYART, MD, PhD,, Study director, Assistance Publique Hôpitaux de Paris, Université Paris Descartes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02471937
- Sponsor's protocol ID
- 2014-A01824-43
- Acronym
- STREPB17
- Status last verified
- Aug 2025
- First submitted
- 31 Mar 2015
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Plainvert C, Anselem O, Joubrel C, Marcou V, Falloukh A, Frigo A, Magdoud El Alaoui F, Ancel PY, Jarreau PH, Mandelbrot L, Goffinet F, Poyart C, Tazi A. Persistence of group B Streptococcus vaginal colonization and prevalence of hypervirulent CC-17 clone correlate with the country of birth: a prospective 3-month follow-up cohort study. Eur J Clin Microbiol Infect Dis. 2021 Jan;40(1):133-140. doi: 10.1007/s10096-020-04011-6. Epub 2020 Aug 18.
PubMed 32812077
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrative Approach to Identify Environmental Risk Factors for CC-17 Group B Streptococcal Neonatal Infection
- ClinicalTrials.gov ID
- NCT02471937
- Acronym / sponsor ID
- STREPB17 / 2014-A01824-43
- Conditions
- Vaginal Colonization With GBS
- Keywords
- Streptococcus agalactiae, Group B Streptococcus, Neonates, colonization, meningitis, Clonal Complex CC17, microbiota, next generation sequencing (NGS)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 1 Jun 2015 (actual)
- Primary completion
- 28 Apr 2016 (actual)
- Study completion
- 28 Apr 2016 (actual)
- First posted
- 15 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women negative for GBS colonization | Experimental | Biological: Bacteriological analyses on clinical samples performed with EswabsOnly women negative for GBS during all the study will be included. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Patient does not speak and does not understand French
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bacteriological analyses on clinical samples performed with EswabsClinical samples analysed : mothervagina, breast milk, baby oral cavity, baby stool. Techniques: bacteriological cultures, Real time PCR | Biological | Pregnant women negative for GBS colonization |
Primary outcome
Number of Negative GBS screening in vaginal samples
Time frame: 2 months
3 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
- Results publication: PubMed 32812077Plainvert C, Anselem O, Joubrel C, Marcou V, Falloukh A, Frigo A, Magdoud El Alaoui F, Ancel PY, Jarreau PH, Mandelbrot L, Goffinet F, Poyart C, Tazi A. Persistence of group B Streptococcus vaginal colonization and prevalence of hypervirulent CC-17 clone correlate with the country of birth: a prospective 3-month follow-up cohort study. Eur J Clin Microbiol Infect Dis. 2021 Jan;40(1):133-140. doi: 10.1007/s10096-020-04011-6. Epub 2020 Aug 18.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claire POYART, MD, PhD, study director
Assistance Publique Hôpitaux de Paris, Université Paris Descartes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bacteriological analyses on clinical samples performed with Eswabs in people with Vaginal Colonization With GBS, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Negative GBS screening in vaginal samples (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02471937, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2025.