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Could probiotic capsules beat bacterial vaginosis?

NCT ID NCT07418918

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether vaginal capsules containing two types of Lactobacillus probiotics can treat bacterial vaginosis, a common vaginal infection. Sixty-six women received either the probiotic capsule or a placebo. The goal was to see if the probiotics could restore normal vaginal conditions and clear the infection. Results may point to a gentler alternative to antibiotics.

What this could mean

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

Active substance
Lactobacillus dual probiotic vaginal capsules
What this could lead to
If it works, this could provide a new, non-antibiotic treatment for bacterial vaginosis, helping restore natural vaginal balance.
What could go wrong
This is a small Phase 2 trial, so results may not confirm effectiveness. The placebo group also shows improvement in some studies, and long-term benefits are unknown.

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

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

66 people

The number who actually took part.

Started

Jan 2023

Finished

Nov 2023

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 50 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: 1. The subject fully understands the purpose, nature, methods, and potential adverse reactions of the trial, voluntarily participates in the study, and provides written informed consent prior to trial commencement; 2. Female aged 18 to 50 years (inclusive of the boundary values); 3. History of sexual activity, willing to undergo vaginal administration of medication, and agrees to refrain from using other intravaginal products (e.g., contraceptive creams, gels, foams, sponges, lubricants, douches, tampons, etc.) and from engaging in sexual activity throughout the entire trial period; 4. Has a normal and regular menstrual cycle; 5. Clinically diagnosed with bacterial vaginosis (BV), defined as having at least three positive findings on Amsel's criteria, including the presence of clue cells (i.e., clue cells accounting for \>20% of the total vaginal epithelial cells); and a Nugent score ≥ 7 points. Exclusion Criteria: 1. Known allergy to any component of the investigational drug; 2. Known current diagnosis of pelvic inflammatory disease, cervicitis, or acute urogenital infection; 3. Vulvovaginitis due to other infectious etiologies, such as vulvovaginal candidiasis (VVC), trichomonal vaginitis (TV), aerobic vaginitis (AV score ≥5), gonorrhea, or Chlamydia trachomatisinfection,etc; 4. Pelvic examination at screening reveals the presence of condyloma acuminata (genital warts); 5. History of complicated or recurrent VVC within 1 year prior to screening; 6. Known diagnosis of uterine fibroids or adenomyosis requiring intervention as assessed by the investigator; 7. Vaginal speculum examination at screening indicates significant vaginal mucosal injury (e.g., mucosal edema, ulceration, erosion); 8. History of significant diseases affecting the cardiovascular, hepatic, renal, pulmonary, gastrointestinal, neurological, metabolic, urogenital, endocrine, or psychiatric systems, which in the investigator's judgment may compromise subject safety; 9. Use of vaginal douching or other intravaginal treatments (e.g., products such as Jie Er Yin, Jie Yin Kang) within 72 hours prior to dosing or anticipated use during the trial period; 10. Received antibiotic or antifungal treatment (systemic and/or intravaginal) within 2 weeks prior to dosing; 11. Current use of long-acting contraceptive injections or oral contraceptives at screening; 12. History of gynecological surgery within 2 months prior to screening; 13. Positive virological tests for syphilis or HIV at screening; 14. Positive pregnancy test at screening; or history of pregnancy termination within 2 months prior to screening; or women of childbearing potential who, in the investigator's judgment, cannot use a medically approved and reliable contraceptive method from the time of signing the informed consent until 3 months after the last dose of the study drug; 15. Women who are pregnant or breastfeeding; 16. Participation in any other drug or medical device clinical trial within 3 months prior to dosing, involving the use of investigational drugs or devices; Any other medical condition that, in the investigator's judgment, may affect the assessment of the study.

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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.

Contacts and locations

Locations

  • Guangdong Longchuangji Pharmaceutical Co., Ltd.

    Chaozhou, Guangdong, 521000, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.