Good bacteria vs. bad: new trial aims to stop BV from coming back
NCT ID NCT07474831
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
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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
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About 132 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Apr 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 45 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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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.
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The places running it
11 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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AIED Centre
RECRUITINGRome, Lazio, Italy
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Clinica Villa Margherita
RECRUITINGRome, Lazio, Italy
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Department of Obstetrics and Gynecology, Fondazione IRCCS Policlinico San Matteo, Università Degli Studi di Pavia
RECRUITINGPavia, Lombardy, 27100, Italy
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Department of Obstetrics and Gynecology, Ospedale Maria Vittoria
RECRUITINGTurin, Piedmont, 10144, Italy
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Dipartimento di Ostetricia e Ginecologia, Policlinico Tor Vergata, Università Roma Tor Vergata
RECRUITINGRome, Lazio, Italy
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Gynecology and Obstetrics Department, San Marco Hospital
RECRUITINGCatania, Sicily, Italy
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Olympus Centro Medico Polispecialistico
RECRUITINGRavenna, Emilia-Romagna, 48122, Italy
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Screening and Secondary Prevention Unit, Institute for Cancer Research, Prevention and Oncological Network (ISPRO)
RECRUITINGFlorence, Tuscany, Italy
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Studio medico
RECRUITINGForlì, Emilia-Romagna, 47121, Italy
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UOC Ginecologica ed Ostetricia, Poliambulanza Istituto Ospedaliero
RECRUITINGBrescia, Lombardy, 25124, Italy
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UOC Ostetricia e Ginecologia, Ospedale Apuane, AUSL Toscana Nord-Ovest
RECRUITINGMassa, Tuscany, 54100, Italy
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