Could 'Good' bacteria beat a common vaginal infection?
NCT ID NCT07418996
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested whether vaginal capsules containing live lactobacilli (good bacteria) are safe and tolerable for treating bacterial vaginosis (BV), a common infection. Fifty-seven women with BV took either the lactobacillus capsules or the standard antibiotic metronidazole. The main goal was to check for side effects, with secondary goals looking at cure and recurrence rates.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- live lactobacillus vaginal capsules
- What this could lead to
- If successful, this could offer a new treatment option for bacterial vaginosis that uses beneficial bacteria instead of antibiotics.
- What could go wrong
- This is a small early-phase trial focused on safety, not effectiveness. The treatment may not work better than existing options, and results may not apply to all women.
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
-
57 people
The number who actually took part.
- Started
-
May 2021
- Finished
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Sep 2022
- 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. Female, aged 18-50 years (inclusive), with prior sexual experience, willing to undergo vaginal drug administration, and agreeing to refrain from using intravaginal products (such as contraceptive creams, gels, foams, sponges, lubricants, douches, tampons, etc.) not specified in the study throughout the entire trial period. 2. Having a regular menstrual cycle (21-35 days). 3. Clinical diagnosis of bacterial vaginosis (BV), defined as meeting at least three of the Amsel criteria, with clue cells exceeding 20% of the total vaginal epithelial cells, and a Nugent score ≥ 7. 4. Able to understand and voluntarily sign the informed consent form. Exclusion Criteria: 1. Individuals with a history of allergies or known hypersensitivity to any known component of the investigational product. 2. Known current diagnosis of pelvic inflammatory disease, cervicitis, or acute urogenital infection. 3. Diagnosis of vulvovaginal candidiasis (VVC), trichomonal vaginitis (TV), or aerobic vaginitis (AV, with a score ≥5). 4. Use of vaginal douching or other intravaginal treatments within 14 days prior to screening, or anticipated use during the trial period. 5. Known diagnosis of uterine fibroids, endometrial hyperplasia, or adenomyosis requiring intervention, as assessed by the investigator. 6. Patients who have used topical or systemic antimicrobial or antimycotic agents within 14 days prior to screening, or are anticipated to require such treatment during the trial period. 7. History of gynecological surgery within 2 months prior to screening. 8. Vaginal speculum examination at screening reveals significant vaginal mucosal damage (e.g., mucosal edema, congestion, ulceration, erosion). 9. History of major diseases affecting the cardiovascular, hepatic, renal, pulmonary, gastrointestinal, neurological, metabolic, urogenital, endocrine, or psychiatric systems, which in the investigator's judgment may compromise the subject's safety. 10. Any of the following laboratory findings at screening: Hemoglobin (HGB) \< 100 g/L; White blood cell (WBC) count \< 3.5 × 10⁹/L, or neutrophil count (NEUT) \< 1.5 × 10⁹/L; Platelet (PLT) count \< 80 × 10⁹/L; Serum creatinine (Cr) \> 1.5 × upper limit of normal (ULN); Blood urea nitrogen (BUN) \> 1.5 × ULN; Alanine aminotransferase (ALT) \> 1.5 × ULN; Aspartate aminotransferase (AST) \> 1.5 × ULN; Alkaline phosphatase (ALP) \> 1.5 × ULN; Total bilirubin (TBIL) \> 1.5 × ULN. 11. Participation in a clinical study within 3 months prior to screening. 12. Planning pregnancy within 2 months before screening to 6 months after the trial, or positive pregnancy test at screening. 13. Termination of pregnancy within 60 days prior to screening. 14. Lactating or postmenopausal women. 15. Physical conditions, concurrent surgeries, medications, or clinically significant abnormal laboratory findings that may affect the evaluation of the investigational product, as determined by the investigator. 16. Any other circumstances deemed unsuitable for participation in this study by the investigator.
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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
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Other studies related to the condition(s) this trial covers.