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Bacterial Vaginosis (BV)Phase 2BVNCT07418996

Live Double Combined Lactobacillus Capsule for Vaginal Use（IIa）

A Phase 2 study of Bacterial Vaginosis (BV), run by Guangdong Longchuangji Pharmaceutical Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a mutilcenter, randomized, double-blind, Metronidazole controlled phase lIa clinical study to evaluate the safety and tolerability of dual - live lactobacilli-containing vaginal capsules 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 (BV)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
57 participants
Where
1 siteChina
Study dates
18 May 2021to 30 Sep 2022
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

  • 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.
  • Having a regular menstrual cycle (21-35 days).
  • 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.
  • Able to understand and voluntarily sign the informed consent form.

Who cannot join

  • Individuals with a history of allergies or known hypersensitivity to any known component of the investigational product.
  • Known current diagnosis of pelvic inflammatory disease, cervicitis, or acute urogenital infection.
  • Diagnosis of vulvovaginal candidiasis (VVC), trichomonal vaginitis (TV), or aerobic vaginitis (AV, with a score ≥5).
  • Use of vaginal douching or other intravaginal treatments within 14 days prior to screening, or anticipated use during the trial period.
  • Known diagnosis of uterine fibroids, endometrial hyperplasia, or adenomyosis requiring intervention, as assessed by the investigator.
  • 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.
Show all 17Show fewer
  • History of gynecological surgery within 2 months prior to screening.
  • Vaginal speculum examination at screening reveals significant vaginal mucosal damage (e.g., mucosal edema, congestion, ulceration, erosion).
  • 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.
  • 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.
  • Participation in a clinical study within 3 months prior to screening.
  • Planning pregnancy within 2 months before screening to 6 months after the trial, or positive pregnancy test at screening.
  • Termination of pregnancy within 60 days prior to screening.
  • Lactating or postmenopausal women.
  • 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.
  • Any other circumstances deemed unsuitable for participation in this study by the investigator.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Guangdong Longchuangji Pharmaceutical Co., Ltd.

    Chaozhou, Guangdong, 521000

Other trials in China

About this study

Official title: A Multicenter, Randomized, Double-Blind, Metronidazole-Controlled Phase IIa Clinical Study on the Safety and Tolerability of Dual Live Lactobacilli-containing Vaginal Capsules in the Treatment of Bacterial Vaginosis

This is a mutilcenter, randomized, double-blind, Metronidazole controlled phase lIa clinical study to evaluate the safety and tolerability of dual - live lactobacilli-containing vaginal capsules for the treatment of Bacterial Vaginosis.

Read the detailed description

This phase of research adopts a mutilcenter, randomized, double-blind, Metronidazole controlled, dose-escalation, and multiple administration design. From May 2021 to July 2022, 60 subjects with BV were planned to be enrolled in multiple hospitals across the country. The test drug, a dual live bacteria formulation, was set up in three dose groups (1×10⁷ CFU/capsule, 1×10⁸ CFU/capsule, and 1×10⁹ CFU/capsule), with metronidazole tablets as the positive control in each group. Each group was planned to include 20 subjects, who were randomly assigned to the test group or the control group in a 3:1 ratio. A randomization table was generated using SAS 9.4, with each group randomized independently and enrolled in ascending order of dose according to the principle of dose escalation. Only after the current dose group completed the safety observation on Day 9 and confirmed to be safe and tolerable, could enrollment in the higher dose group be initiated.

Being tested
Live double combined lactobacillus capsule for vaginal use（1*10^7CFU/capsule）+Metronidazole placebo, Low-dose group: Live double combined lactobacillus capsule placebo+Metronidazole, Live double combined lactobacillus capsule for vaginal use（1*10^8CFU/capsule）+Metronidazole placebo, Medium-dose group: Live double combined lactobacillus capsule placebo+Metronidazole, Live double combined lactobacillus capsule for vaginal use（1*10^9CFU/capsule）+Metronidazole placebo
Keywords
Bacterial vaginosis, Lactobacillus gasseri, Lactobacillus rhamnosus, Probiotics, 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.

  • Live double combined lactobacillus capsule for vaginal use（1*10^7CFU/capsule）+Metronidazole placeboDrug

    Live double combined lactobacillus capsule for vaginal use（1*10^7CFU/capsule）+Metronidazole placebo, double-blind, double-dummy administration regimen

  • Low-dose group: Live double combined lactobacillus capsule placebo+MetronidazoleDrug

    Low-dose group:Live double combined lactobacillus capsule placebo+Metronidazole, double-blind, double-dummy administration regimen.

  • Live double combined lactobacillus capsule for vaginal use（1*10^8CFU/capsule）+Metronidazole placeboDrug

    Live double combined lactobacillus capsule for vaginal use（1*10^8CFU/capsule）+Metronidazole placebo, double-blind, double-dummy administration regimen

  • Medium-dose group: Live double combined lactobacillus capsule placebo+MetronidazoleDrug

    Medium-dose group: Live double combined lactobacillus capsule placebo+Metronidazole, double-blind, double-dummy administration regimen

  • Live double combined lactobacillus capsule for vaginal use（1*10^9CFU/capsule）+Metronidazole placeboDrug

    Live double combined lactobacillus capsule for vaginal use（1*10^9CFU/capsule）+Metronidazole placebo, double-blind, double-dummy administration regimen.

  • High-dose group: Live double combined lactobacillus capsule placebo+MetronidazoleDrug

    High-dose group: Live double combined lactobacillus capsule placebo+Metronidazole, double-blind, double-dummy administration regimen.

Study groups in NCT07418996
Study groupRoleWhat they receive
Live double combined lactobacillus capsule for vaginal use（1*10^7CFU/capsule）+Metronidazole placeboExperimentalLive double combined lactobacillus capsule for vaginal use（1*10^7CFU/capsule）+Metronidazole placebo, Double-blind, double-dummy design.
Receives: Drug: Live double combined lactobacillus capsule for vaginal use（1*10^7CFU/capsule）+Metronidazole placebo
Low-dose group: Live double combined lactobacillus capsule placebo+MetronidazoleActive comparatorLow-dose group: Live double combined lactobacillus capsule placebo+Metronidazole, Double-blind, double-dummy design.
Receives: Drug: Low-dose group: Live double combined lactobacillus capsule placebo+Metronidazole
Live double combined lactobacillus capsule for vaginal use（1*10^8CFU/capsule）+Metronidazole placeboExperimentalLive double combined lactobacillus capsule for vaginal use（1*10^8CFU/capsule）+Metronidazole placebo, Double-blind, double-dummy design.
Receives: Drug: Live double combined lactobacillus capsule for vaginal use（1*10^8CFU/capsule）+Metronidazole placebo
Medium-dose group: Live double combined lactobacillus capsule placebo+MetronidazoleActive comparatorMedium-dose group: Live double combined lactobacillus capsule placebo+Metronidazole, Double-blind, double-dummy design.
Receives: Drug: Medium-dose group: Live double combined lactobacillus capsule placebo+Metronidazole
Live double combined lactobacillus capsule for vaginal use（1*10^9CFU/capsule）+Metronidazole placeboExperimentalLive double combined lactobacillus capsule for vaginal use（1*10^9CFU/capsule）+Metronidazole placebo, Double-blind, double-dummy design.
Receives: Drug: Live double combined lactobacillus capsule for vaginal use（1*10^9CFU/capsule）+Metronidazole placebo
High-dose group: Live double combined lactobacillus capsule placebo+MetronidazoleActive comparatorHigh-dose group: Live double combined lactobacillus capsule placebo+Metronidazole, Double-blind, double-dummy design.
Receives: Drug: High-dose group: Live double combined lactobacillus capsule placebo+Metronidazole

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

  2. Incidence of treatment-related adverse events (Safety Evaluation)

    A treatment-related adverse event referred to any treatment-emergent adverse events with causal association to the treatment.

    Measured: Through study completion, an average of 30 days

Secondary outcomes (3)

  1. Cure rate of bacterial vaginosis in subjects

    Measured: Day 12 to Day 16

  2. Recurrence rate of bacterial vaginosis in subjects

    Recurrence rate at Day 25 to Day 31

    Measured: Day 25 to Day 31

  3. Cure rate of bacterial vaginosis in subjects

    Measured: Day 25 to Day 31

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Feb 2026
  2. Study start18 May 2021
  3. Primary completion4 Jul 2022
  4. Study completion30 Sep 2022

Resources

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 phase of the study will adopt a multicenter, randomized, double-blind, double-dummy, metronidazole-controlled, dose-escalation, and multiple-dose design. The investigational drug, a combination of Lactobacillus gasseri and Lactobacillus rhamnosus, will be administered in three dose groups: 1×10⁷ CFU/capsule, 1×10⁸ CFU/capsule, and 1×10⁹ CFU/capsule. Each dose group will use metronidazole tablets as the positive control. Each group is planned to enroll 20 subjects, who will be randomly assigned to either the investigational group or the control group in a 3:1 ratio. A randomization list will be generated using SAS 9.4, with separate randomization for each group. Subjects will be enrolled in ascending order of dose. Enrollment into the next higher dose group will only be initiated after the current dose group has completed the Day 9 safety observation and confirmed safety and tolerability.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
57 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07418996
Sponsor's protocol ID
LCJ-LACT-102
Other IDs
LCJ-LACT-102
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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study of Bacterial Vaginosis (BV), 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 4 inclusion and 17 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. 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?

Incidence of Treatment-emergent adverse events (Safety Evaluation) (time frame: Through study completion, an average of 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07418996.

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.

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