Efficacy and Safety of Vaginal Lactobacillus Dual Probiotic Capsules in Bacterial Vaginosis

NCT07418957 | Completed Phase 3

• 1 other identifier: CTS-CO-2666
• Study Type: interventional
• Target: 402
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objective: To confirm that the clinical cure rate of Vaginal Lactobacillus Dual Probiotic Capsules for bacterial vaginosis (BV) is superior to placebo at the 21-30 day post-treatment visit (Day 21 to Day 30). Key Secondary Objective: To compare the clinical cure rate of Vaginal Lactobacillus Dual Probiotic Capsules versus placebo for BV at the 15-18 day post-treatment visit (Day 15 to Day 18). Other Secondary Objectives: 1) To comprehensively assess the therapeutic efficacy of the study drug versus placebo for BV at Day 15 to 18 and Day 21 to 30; 2) To evaluate the safety profile of the study drug for BV treatment compared with placebo, including adverse events and clinical laboratory findings. Study Design \& Randomization: This is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical trial. An independent biostatistician generated the subject and drug randomization lists via SAS software, which were imported into an Interactive Web Response System (IWRS). Investigators at each site obtain randomization and drug numbers through the IWRS for subject allocation. Blinding \& Allocation Concealment: Double-blinding is implemented for both investigators and subjects. The study drug and placebo are identical in appearance, shape, specification, and dosage form. Blinding procedures are performed by personnel unrelated to the trial, with a complete and detailed record of the entire blinding process maintained throughout the study.

Conditions

Bacterial Vaginosis (BV)

Keywords

Bacterial Vaginosis (BV)

Outcome Measures

Primary Outcomes (1)

• Clinical Cure Rate

  Day 21 to Day 30

Secondary Outcomes (9)

• Clinical Cure Rate

  Day 15 to Day 18

• Rate of Nugent score<7

  Day 15 to to Day 18

• Rate of Nugent score<4

  Day 15 to Day 18

• Rate of Participants with Both Clinical Cure and Nugent Score < 7

  Day 15 to Day 18

• Rate of Participants with Both Clinical Cure and Nugent Score < 4

  Day 15 to Day 18

Study Arms (2)

Probiotic Group

EXPERIMENTAL

Vaginal Lactobacillus Dual Probiotic Capsules: Insert the capsule deep into the vagina. Administer one capsule twice daily (morning and evening) for 14 consecutive days.

Drug: Vaginal Lactobacillus Dual Probiotic Capsules

Control Group

PLACEBO COMPARATOR

Placebo: Insert the capsule deep into the vagina. Administer one capsule twice daily (morning and evening) for 14 consecutive days.

Other: Placebo

Interventions

Vaginal Lactobacillus Dual Probiotic Capsules DRUG

Investigational product for the treatment of BV, administered vaginally as per study protocol.

Probiotic Group

Placebo OTHER

Placebo, matching the investigational product in appearance, dosage form, and route of administration, used as the control intervention in this double-blind, randomized trial.

Control Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• The subjects fully understand the purpose, nature, methods, and potential adverse reactions of the trial, voluntarily participate in the study, and sign an informed consent form before the trial begins;
• Females aged ≥18 years and ≤50 years, with normal and regular menstrual cycles;
• Have a history of sexual activity, are willing to undergo vaginal medication, and agree to avoid using other intravaginal products (such as contraceptive creams, gels, foams, sponges, lubricants, douches, tampons, etc.) and sexual activity throughout the entire trial period;
• Clinically diagnosed with Bacterial Vaginosis (BV), requiring the simultaneous satisfaction of all four Amsel criteria:
• Positive clue cells;
• Positive amine (whiff) test;
• Vaginal discharge pH \> 4.5;
• Vaginal discharge is homogeneous, thin, and grayish-white in appearance.
• Nugent score ≥ 7 points.

You may not qualify if:

• Known allergy to any component of the investigational drug;
• Known current diagnosis of pelvic inflammatory disease, cervicitis, or acute urogenital tract infections;
• Presence of vulvovaginitis caused by other infectious etiologies, such as vulvovaginal candidiasis (VVC), trichomonal vaginitis (TV), aerobic vaginitis (AV score ≥3), gonorrhea, Chlamydia trachomatisinfection, etc.;
• Pelvic examination at screening reveals the presence of condyloma acuminata;
• History of complicated or recurrent VVC within 1 year prior to screening;
• Known diagnosis of uterine myoma or adenomyosis requiring interventional treatment, as judged by the investigator;
• Vaginal speculum examination at screening shows significant vaginal mucosal injury (e.g., mucosal edema, ulceration, erosion);
• History of significant diseases involving the cardiovascular, hepatic, renal, pulmonary, gastrointestinal, neurological, metabolic, urogenital, endocrine, or psychiatric systems, which in the investigator's judgment may affect participant safety;
• Use of vaginal douching or other intravaginal treatments (e.g., products like 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 injectable contraceptives or long-acting oral contraceptives at screening;
• History of gynecological surgery or common procedures that may affect the vaginal microenvironment within 2 months prior to screening (including but not limited to Bartholin's cyst/abscess incision, intrauterine device removal/insertion, cervical or vaginal wall biopsy, cervical conization or loop electrosurgical excision procedure \[LEEP\]);
• Virological testing at screening is positive for syphilis or HIV;
• 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, reliable method of contraception from the time of signing the informed consent form until 3 months after the last dose of the study drug;
• Women who are pregnant or breastfeeding;

Sponsors & Collaborators

• Guangdong Longchuangji Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Tianjin Medical University General Hospital

Tianjin, No. 154, Anshan Road, Heping District, 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 Officials

• Fengxia F Xue, Study leader

  Tianjin Medical University General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Treatment Group:Vaginal Lactobacillus Dual Probiotic Capsules: Insert the capsule deep into the vagina. Administer one capsule twice daily (morning and evening) for 14 consecutive days. Control Group:Placebo: Insert the capsule deep into the vagina. Administer one capsule twice daily (morning and evening) for 14 consecutive days.

Study Record Dates

• First Submitted: February 4, 2026
• First Posted: February 18, 2026
• Study Start: June 12, 2024
• Primary Completion: May 17, 2025
• Study Completion: July 3, 2025
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)