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Scientists hunt for hidden triggers of deadly newborn infection

NCT ID NCT02471937

Knowledge-focused Sponsor: Assistance Publique - Hôpitaux de Paris Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study examined 151 mothers and their newborns to understand why some babies get a severe infection from a specific strain of Group B Strep (GBS). Researchers tested samples from the mother's vagina, breast milk, and the baby's mouth and stool. They hope to find how gut bacteria and the immune system might allow this dangerous strain to take hold.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could point toward ways to prevent dangerous GBS infections in newborns.
What could go wrong
This is an observational study, not a treatment trial. It only looks for risk factors, so it won't directly change care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

151 people

The number who actually took part.

Started

Jun 2015

Finished

Apr 2016

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

meningitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Vaginal colonization with GBS

Contacts and locations

Locations

  • CH Louis Mourier

    Colombes, 92 700, France