Could probiotic capsules beat bacterial vaginosis?
NCT ID NCT07418918
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
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Jan 2023
- Finished
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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
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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 Hide 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
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Guangdong Longchuangji Pharmaceutical Co., Ltd.
Chaozhou, Guangdong, 521000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Friendly bacteria vs. vaginal infections: a new trial puts probiotics to the test
- Can a simple Self-Test cut preterm births in High-Risk pregnancies?
- Vaginal device aims to boost infection treatment
- Blue light could soothe vaginal disorders without hormones
- New vaginal capsule aims to tackle stubborn bacterial vaginosis
- Can a probiotic stop bacterial vaginosis recurrence?