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Good bacteria vs. bad: new trial aims to stop BV from coming back

NCT ID NCT07474831

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 03, 2026 · Updated 2 times

Summary

This study tests whether a probiotic supplement containing Lactobacillus crispatus can reduce the number of times bacterial vaginosis (BV) comes back in women who have had it repeatedly. About 156 women aged 18-45 will take either the probiotic or a placebo daily for 12 weeks after standard antibiotic treatment. The goal is to see if the probiotic helps maintain a healthy vaginal balance and prevents recurrence.

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

About 132 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Apr 2027

An estimate. End dates often move.

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 to 45 years

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: * Women aged 18-45 years * Diagnosis of recurrent bacterial vaginosis (≥3 episodes of bacterial vaginosis within 12 months prior to enrollment) * Presence of a diagnosis of bacterial vaginosis at the time of enrollment, carried out through the presence of 3 out of 4 of the Amsel Criteria * Accepted written informed consent for study participation obtained prior to the start of the study Exclusion Criteria: * Age \<18 years or \>45 years * Concomitant presence of Candida vulvovaginitis * Pregnancy * Breastfeeding * Use of other therapies for the prevention of bacterial vaginosis in the previous 30 days * Alcohol or drug abuse * Known allergy to the components of the product used * Lack of acceptance of written informed consent

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    11 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AIED Centre

    RECRUITING

    Rome, Lazio, Italy

  • Clinica Villa Margherita

    RECRUITING

    Rome, Lazio, Italy

  • Department of Obstetrics and Gynecology, Fondazione IRCCS Policlinico San Matteo, Università Degli Studi di Pavia

    RECRUITING

    Pavia, Lombardy, 27100, Italy

  • Department of Obstetrics and Gynecology, Ospedale Maria Vittoria

    RECRUITING

    Turin, Piedmont, 10144, Italy

  • Dipartimento di Ostetricia e Ginecologia, Policlinico Tor Vergata, Università Roma Tor Vergata

    RECRUITING

    Rome, Lazio, Italy

  • Gynecology and Obstetrics Department, San Marco Hospital

    RECRUITING

    Catania, Sicily, Italy

  • Olympus Centro Medico Polispecialistico

    RECRUITING

    Ravenna, Emilia-Romagna, 48122, Italy

  • Screening and Secondary Prevention Unit, Institute for Cancer Research, Prevention and Oncological Network (ISPRO)

    RECRUITING

    Florence, Tuscany, Italy

  • Studio medico

    RECRUITING

    Forlì, Emilia-Romagna, 47121, Italy

  • UOC Ginecologica ed Ostetricia, Poliambulanza Istituto Ospedaliero

    RECRUITING

    Brescia, Lombardy, 25124, Italy

  • UOC Ostetricia e Ginecologia, Ospedale Apuane, AUSL Toscana Nord-Ovest

    RECRUITING

    Massa, Tuscany, 54100, Italy

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