Live Double Combined Lactobacillus Capsule for Vaginal Use（IIa）

NCT07418996 | Completed Phase 2

• 1 other identifier: LCJ-LACT-102
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bacterial Vaginosis (BV)

Keywords

Bacterial vaginosis; Lactobacillus gasseri; Lactobacillus rhamnosus; Probiotics; Multicenter study

Outcome Measures

Primary Outcomes (2)

• 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.

  Through study completion, an average of 30 days

• 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.

  Through study completion, an average of 30 days

Secondary Outcomes (3)

• Cure rate of bacterial vaginosis in subjects

  Day 12 to Day 16

• Recurrence rate of bacterial vaginosis in subjects

  Day 25 to Day 31

• Cure rate of bacterial vaginosis in subjects

  Day 25 to Day 31

Other Outcomes (1)

• To explore the changes in the abundance of Lactobacillus in the vagina of BV subjects before and after medication.

  Baseline, at Day 12 to Day 16, and at Day 25 to Day 31

Study Arms (6)

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

EXPERIMENTAL

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

Drug: Live double combined lactobacillus capsule for vaginal use（1*10^7CFU/capsule）+Metronidazole placebo

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

ACTIVE COMPARATOR

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

Drug: Low-dose group: Live double combined lactobacillus capsule placebo+Metronidazole

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

EXPERIMENTAL

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

Drug: Live double combined lactobacillus capsule for vaginal use（1*10^8CFU/capsule）+Metronidazole placebo

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

ACTIVE COMPARATOR

Medium-dose group: Live double combined lactobacillus capsule placebo+Metronidazole, Double-blind, double-dummy design.

Drug: Medium-dose group: Live double combined lactobacillus capsule placebo+Metronidazole

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

EXPERIMENTAL

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

Drug: Live double combined lactobacillus capsule for vaginal use（1*10^9CFU/capsule）+Metronidazole placebo

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

ACTIVE COMPARATOR

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

Drug: High-dose group: Live double combined lactobacillus capsule placebo+Metronidazole

Interventions

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

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

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

Low-dose group: Live double combined lactobacillus capsule placebo+Metronidazole DRUG

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

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

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

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

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

Medium-dose group: Live double combined lactobacillus capsule placebo+Metronidazole DRUG

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

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

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

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

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

High-dose group: Live double combined lactobacillus capsule placebo+Metronidazole DRUG

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

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

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Gender Eligibility Description
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Guangdong Longchuangji Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Guangdong Longchuangji Pharmaceutical Co., Ltd.

Chaozhou, Guangdong, 521000, China

Location

MeSH Terms

Conditions

Vaginosis, Bacterial

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This trial employs a block randomization method, with each dose group being randomized separately. The randomization numbers and their corresponding treatment assignments are generated using SAS software (version 9.4). The randomization list (i.e., the blinding codes) is sealed in duplicate, with one copy stored by the sponsor and the other by the lead study unit. The randomization number serves as the blinded drug code for drug allocation. After subjects are screened and deemed eligible, researchers dispense the drugs sequentially in ascending order of the drug codes. On-site drug blinding is conducted by personnel from the statistical unit and the sponsor, who are otherwise unrelated to the trial. The predetermined randomization numbers (drug codes) are either written or affixed onto drug labels. A record of the blinding procedure is maintained and archived.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 4, 2026
• First Posted: February 18, 2026
• Study Start: May 18, 2021
• Primary Completion: July 4, 2022
• Study Completion: September 30, 2022
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)