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Can a probiotic stop bacterial vaginosis recurrence?

NCT ID NCT07527572

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tests whether a probiotic called Lactobacillus gasseri KABP®064 can prevent bacterial vaginosis (BV) from returning after standard antibiotic treatment. BV is a common vaginal infection that often comes back within a year. The trial will involve 160 women with a history of recurrent BV. Participants will take either the probiotic or a placebo daily for 15 days, then 10 days per month for six months, and researchers will track how many have a recurrence.

What this could mean

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

Active substance
Lactobacillus gasseri KABP®064 (a probiotic)
What this could lead to
If it works, this could offer a non-antibiotic way to reduce the high rate of bacterial vaginosis recurrence, improving vaginal health and quality of life.
What could go wrong
This is an early-phase trial (Phase 2/3) with only 160 participants. The probiotic may not prevent recurrence better than placebo, and individual results may vary.

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

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 160 people

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

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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: * Females of ages 18-45 years (both values included) who are premenopausal. * History of recurrent BV (at least 3 episodes in the last 12 months with at least one of them documented in the last 6 months). * Positive Amsel's criteria (confirming active BV) determined by at least 3 out of the following 4 symptoms or signs: * Homogeneous, thin, yellowish-white/greyish white discharge that smoothly coats the vaginal walls. * Presence of the clue cells on microscopic examination (as assessed by wet mount test). * A fishy odor of vaginal discharge after adding 10% potassium hydroxide (KOH) solution to wet mount - also known as "whiff test". * Vaginal pH \> 4.5 * Imbalance in vaginal pH (pH \> 4.5). * Participants with Body Mass Index (BMI) 18.5-32.0 kg/m2. * Non-smokers. * Participants able to comply with and perform the procedures requested by the protocol (including dietary restrictions, consumption of study treatments, blood and urine sample collection procedures and study visit schedule). * Participants who are literate enough to understand the essence of study, are informed about the purpose of the study, and understand their rights. * Participants able to give written informed consent and willingness to participate in the study and comply with its procedures. Exclusion Criteria: * Participants currently taking contraceptives and/or sexual hormones. * Pregnant or breastfeeding. * Menstrual period expected within the next 6 days of screening. * Irregular cycle ("irregular" (e.g., less than 21 or more than 35 days consistently, or cycle variability more than 4 days month-to-month). * Participants who have documented resistance to metronidazole. * Participants diagnosed with any vaginal or urinary tract infection other than BV. * Participants who have used other probiotics or antibiotics (vaginal, oral, parenteral) in the last 15 days. * Participants using other vaginal products with bacteriostatic or bactericide activity (such as lactic acid gels, herbal extracts, dequalinum chloride, etc.). * Participants with an intrauterine contraceptive device (IUCD/IUD) in situ at screening. * Participants who have undergone total hysterectomy or any other surgery involving the female reproductive system. * Women diagnosed with Sexually transmitted infections (STIs) or Human immunodeficiency virus (HIV) infection. * Participants diagnosed with Polycystic ovary syndrome (PCOS) or other such diseases that further affect the hormonal homeostasis in women. * Presence of uncontrolled diabetes mellitus (Indicated by Fasting Blood Glucose (FBG) more than or equal to 126 mg/dL. Fasting is defined as no caloric intake for at least 8 hours). * Presence of uncontrolled hypertension (Defined as Systolic Blood Pressure (SBP) more than or equal to 140 mm Hg and/or Diastolic Blood Pressure (DBP) more than or equal to 90 mm Hg). * Untreated previously diagnosed thyroid disorders. * Participants who have a history of any significant neurological and psychiatric condition which may affect the participation and inference of the study's end points. * Participation in other clinical trials in last 3 months prior to screening. * Participants with substance abuse problems defined as: * High-risk drinking as defined by consumption of 4 or more alcohol containing beverages on any Day or 8 or more alcohol containing beverages per week for women. * Participants who have any of the following clinically significant illness, i.e., Cardiovascular, endocrine system, immune system, respiratory system, hepatobiliary system, kidney and urinary system, neuropsychiatric, musculoskeletal, inflammatory, blood and tumors, chronic gastrointestinal diseases, etc. * Any condition that could, in the opinion of the Investigator, preclude the participant's ability to successfully and safely complete the study or that may confound study outcomes.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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  1. The official record

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