Bacterial VaginosisPhase 2BVNCT07418918
Live Double Combined Lactobacillus Capsule for Vaginal Use(IIb)
A Phase 2 study testing Vaginal Lactobacillus Dual Probiotic Capsules in people with Bacterial Vaginosis, run by Guangdong Longchuangji Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This is a multicenter, randomized, double-blind, placebo-controlled phase IIb clinical study, to evaluate the efficacy and safety of the dual - live Lactobacilli-containing vaginal capsule for the treatment of bacterial vaginosis. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Bacterial Vaginosis
- What is being tested?
- Vaginal Lactobacillus Dual Probiotic Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteChina
- Study dates
- 3 Jan 2023to 11 Nov 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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;
- Female aged 18 to 50 years (inclusive of the boundary values);
- 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;
- Has a normal and regular menstrual cycle;
- 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.
Who cannot join
- Known allergy to any component of the investigational drug;
- Known current diagnosis of pelvic inflammatory disease, cervicitis, or acute urogenital infection;
- Vulvovaginitis due to other infectious etiologies, such as vulvovaginal candidiasis (VVC), trichomonal vaginitis (TV), aerobic vaginitis (AV score ≥5), gonorrhea, or Chlamydia trachomatisinfection,etc;
- Pelvic examination at screening reveals the presence of condyloma acuminata (genital warts);
- History of complicated or recurrent VVC within 1 year prior to screening;
- Known diagnosis of uterine fibroids or adenomyosis requiring intervention as assessed by the investigator;
Show all 16Show fewer
- Vaginal speculum examination at screening indicates significant vaginal mucosal injury (e.g., mucosal edema, ulceration, erosion);
- 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;
- 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;
- Received antibiotic or antifungal treatment (systemic and/or intravaginal) within 2 weeks prior to dosing;
- Current use of long-acting contraceptive injections or oral contraceptives at screening;
- History of gynecological surgery within 2 months prior to screening;
- Positive virological tests for syphilis or HIV at screening;
- 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;
- Women who are pregnant or breastfeeding;
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Guangdong Longchuangji Pharmaceutical Co., Ltd.
Chaozhou, Guangdong, 521000
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Study on the Efficacy and Safety of Lactobacillus Bicomponent Viable Capsules for Vaginal Use in the Treatment of Bacterial Vaginosis
This is a multicenter, randomized, double-blind, placebo-controlled phase IIb clinical study, to evaluate the efficacy and safety of the dual - live Lactobacilli-containing vaginal capsule for the treatment of bacterial vaginosis.
- Conditions
- Bacterial Vaginosis
- Being tested
- Vaginal Lactobacillus Dual Probiotic Capsules, Placebo
- Keywords
- Probiotics, Lactobacillus gasseri, Lactobacillus rhamnosus, Bacterial vaginosis, Multicenter study
- Medical subject headings
- Vaginosis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal Lactobacillus Dual Probiotic CapsulesDrug
Vaginal Lactobacillus Dual Probiotic Capsules, at the prescribed dose and course of treatment, for regulating vaginal microecology.
PlaceboDrug
Placebo capsule with the same appearance as the study drug, at the same dose and course of treatment as the experimental group.
| Study group | Role | What they receive |
|---|---|---|
| Vaginal Lactobacillus Dual Probiotic Capsules | Experimental | Not described Receives: Drug: Vaginal Lactobacillus Dual Probiotic Capsules |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Cure Rate
Clinical cure is defined as follows: vaginal secretions return to normal physiological secretions; whiff test is negative; clue cells are negative (i.e., the number of clue cells is less than 20% of the total number of vaginal epithelial cells)
Measured: Day 21 to Day 30
Secondary outcomes (7)
Clinical Cure Rate
Clinical cure is defined as follows: vaginal secretions return to normal physiological secretions; whiff test is negative; clue cells are negative (i.e., the number of clue cells is less than 20% of the total number of vaginal epithelial cells).
Measured: Day 15 to Day 18
Bacteriological Cure Rate
Bacteriological cure is defined as a Nugent score of less than 4
Measured: Day 15 to Day 18
Composite Cure Rate
Comprehensive cure is defined as meeting both clinical cure and bacteriological cure.
Measured: Day 15 to Day 18
Bacteriological Cure Rate
Bacteriological cure is defined as a Nugent score of less than 4
Measured: Day 21 to Day 30
Composite Cure Rate
Comprehensive cure is defined as meeting both clinical cure and bacteriological cure.
Measured: Day 21 to Day 30
Incidence of treatment-emergent adverse events (Safety Evaluation)
A treatment-emergent adverse event was defined as any adverse event occurring on or after the first use of the investigational product, regardless of causality.
Measured: Through study completion, an average of 30 days
Incidence of treatment-related adverse events (Safety Evaluation)
A treatment-related adverse events referred to any treatment-emergent adverse events with causal association to the treatment.
Measured: Through study completion, an average of 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start3 Jan 2023
- Primary completion1 Sep 2023
- Study completion11 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial VaginosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a multicenter, randomized, double-blind, placebo-controlled phase IIb clinical trial designed to evaluate the efficacy and safety of Vaginal Lactobacillus Dual Probiotic Capsules in the treatment of bacterial vaginosis. A total of 66 subjects are planned to be enrolled and randomized in a 2:1 ratio into either the treatment group or the placebo group. Specifically, 44 subjects in the treatment group will receive Vaginal Lactobacillus Dual Probiotic Capsules (containing 1×10⁸ CFU per capsule), while 22 subjects in the placebo group will receive a placebo.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangdong Longchuangji Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07418918
- Sponsor's protocol ID
- CTS-CO-2417
- Other IDs
- CTS-CO-2417
- Acronym
- BV
- Status last verified
- Feb 2026
- First submitted
- 4 Feb 2026
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Study on the Efficacy and Safety of Lactobacillus Bicomponent Viable Capsules for Vaginal Use in the Treatment of Bacterial Vaginosis
- ClinicalTrials.gov ID
- NCT07418918
- Acronym / sponsor ID
- BV / CTS-CO-2417
- Conditions
- Bacterial Vaginosis
- Keywords
- Probiotics, Lactobacillus gasseri, Lactobacillus rhamnosus, Bacterial vaginosis, Multicenter study
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Guangdong Longchuangji Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Jan 2023 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 11 Nov 2023 (actual)
- First posted
- 18 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, randomized, double-blind, placebo-controlled phase IIb clinical study, to evaluate the efficacy and safety of the dual - live Lactobacilli-containing vaginal capsule for the treatment of bacterial vaginosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This study is a multicenter, randomized, double-blind, placebo-controlled phase IIb clinical trial designed to evaluate the efficacy and safety of Vaginal Lactobacillus Dual Probiotic Capsules in the treatment of bacterial vaginosis. A total of 66 subjects are planned to be enrolled and randomized in a 2:1 ratio into either the treatment group or the placebo group. Specifically, 44 subjects in the treatment group will receive Vaginal Lactobacillus Dual Probiotic Capsules (containing 1×10⁸ CFU per capsule), while 22 subjects in the placebo group will receive a placebo.
| Arm | Type | Receives |
|---|---|---|
| Vaginal Lactobacillus Dual Probiotic Capsules | Experimental | Drug: Vaginal Lactobacillus Dual Probiotic Capsules |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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;
- Female aged 18 to 50 years (inclusive of the boundary values);
- 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;
- Has a normal and regular menstrual cycle;
- 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.
Key exclusion criteria (16 listed)
- Known allergy to any component of the investigational drug;
- Known current diagnosis of pelvic inflammatory disease, cervicitis, or acute urogenital infection;
- Vulvovaginitis due to other infectious etiologies, such as vulvovaginal candidiasis (VVC), trichomonal vaginitis (TV), aerobic vaginitis (AV score ≥5), gonorrhea, or Chlamydia trachomatisinfection,etc;
- Pelvic examination at screening reveals the presence of condyloma acuminata (genital warts);
- History of complicated or recurrent VVC within 1 year prior to screening;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vaginal Lactobacillus Dual Probiotic CapsulesVaginal Lactobacillus Dual Probiotic Capsules, at the prescribed dose and course of treatment, for regulating vaginal microecology. | Drug | Vaginal Lactobacillus Dual Probiotic Capsules |
| PlaceboPlacebo capsule with the same appearance as the study drug, at the same dose and course of treatment as the experimental group. | Drug | Placebo |
Primary outcome
Clinical Cure Rate
Time frame: Day 21 to Day 30
Clinical cure is defined as follows: vaginal secretions return to normal physiological secretions; whiff test is negative; clue cells are negative (i.e., the number of clue cells is less than 20% of the total number of vaginal epithelial cells)
7 secondary outcomes
Clinical Cure Rate
Time frame: Day 15 to Day 18
Bacteriological Cure Rate
Time frame: Day 15 to Day 18
Composite Cure Rate
Time frame: Day 15 to Day 18
Bacteriological Cure Rate
Time frame: Day 21 to Day 30
Composite Cure Rate
Time frame: Day 21 to Day 30
Incidence of treatment-emergent adverse events (Safety Evaluation)
Time frame: Through study completion, an average of 30 days
Incidence of treatment-related adverse events (Safety Evaluation)
Time frame: Through study completion, an average of 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Bacterial Vaginosis
Enrolling by invitationObservational study
Prevention of Vaginal Cuff Infection After Hysterectomy by Addition of Vaginal Clindamycin
Surgical Site Infection, Vaginal Cuff Cellulitis
Not yet recruitingPhase 2
WST03 Capsule Combined With Metronidazole for Bacterial Vaginosis
Bacterial Vaginosis (BV)
RecruitingPhase 1
A Randomized, Multicenter, Open-label, Active-controlled Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Multiple Intravaginal Doses of GenSci142 in Patients With Bacterial Vaginosis (BV)
Randomized, Open-label
Not yet recruitingPhase 1
A Study to Test New Investigational Drugs (LCFA-01and LC103) for Bacterial Vaginosis (BV) Treatment
Bacterial Vaginosis
Recruiting
Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis
Bacterial Vaginoses
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vaginal Lactobacillus Dual Probiotic Capsules in people with Bacterial Vaginosis, run by Guangdong Longchuangji Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Cure Rate (time frame: Day 21 to Day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.