Live Double Combined Lactobacillus Capsule for Vaginal Use(IIb) (BV)

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.

Study Overview

• Status: Completed
• Conditions: Bacterial Vaginosis
• Intervention / Treatment: Drug: Vaginal Lactobacillus Dual Probiotic Capsules; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Chaozhou, Guangdong, China, 521000
      • Guangdong Longchuangji Pharmaceutical Co., Ltd.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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;
2. Female aged 18 to 50 years (inclusive of the boundary values);
3. 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;
4. Has a normal and regular menstrual cycle;
5. 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.

Exclusion Criteria:

1. Known allergy to any component of the investigational drug;
2. Known current diagnosis of pelvic inflammatory disease, cervicitis, or acute urogenital infection;
3. Vulvovaginitis due to other infectious etiologies, such as vulvovaginal candidiasis (VVC), trichomonal vaginitis (TV), aerobic vaginitis (AV score ≥5), gonorrhea, or Chlamydia trachomatisinfection,etc;
4. Pelvic examination at screening reveals the presence of condyloma acuminata (genital warts);
5. History of complicated or recurrent VVC within 1 year prior to screening;
6. Known diagnosis of uterine fibroids or adenomyosis requiring intervention as assessed by the investigator;
7. Vaginal speculum examination at screening indicates significant vaginal mucosal injury (e.g., mucosal edema, ulceration, erosion);
8. 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;
9. 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;
10. Received antibiotic or antifungal treatment (systemic and/or intravaginal) within 2 weeks prior to dosing;
11. Current use of long-acting contraceptive injections or oral contraceptives at screening;
12. History of gynecological surgery within 2 months prior to screening;
13. Positive virological tests for syphilis or HIV at screening;
14. 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;
15. Women who are pregnant or breastfeeding;
16. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo capsule with the same appearance as the study drug, at the same dose and course of treatment as the experimental group.
Experimental: Vaginal Lactobacillus Dual Probiotic Capsules	Drug: Vaginal Lactobacillus Dual Probiotic Capsules; Vaginal Lactobacillus Dual Probiotic Capsules, at the prescribed dose and course of treatment, for regulating vaginal microecology.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Day 21 to Day 30

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Day 15 to Day 18
Bacteriological Cure Rate	Bacteriological cure is defined as a Nugent score of less than 4	Day 15 to Day 18
Composite Cure Rate	Comprehensive cure is defined as meeting both clinical cure and bacteriological cure.	Day 15 to Day 18
Bacteriological Cure Rate	Bacteriological cure is defined as a Nugent score of less than 4	Day 21 to Day 30
Composite Cure Rate	Comprehensive cure is defined as meeting both clinical cure and bacteriological cure.	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.	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.	Through study completion, an average of 30 days

Other Outcome Measures

Outcome Measure	Time Frame
Vaginal Lactobacillus Colonization Rate	Day 21 to Day 30

Collaborators and Investigators

• Sponsor: Guangdong Longchuangji Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2023
• Primary Completion (Actual): September 1, 2023
• Study Completion (Actual): November 11, 2023

Study Registration Dates

• First Submitted: February 4, 2026
• First Submitted That Met QC Criteria: February 11, 2026
• First Posted (Actual): February 18, 2026

Study Record Updates

• Last Update Posted (Actual): February 18, 2026
• Last Update Submitted That Met QC Criteria: February 11, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Probiotics; Bacterial vaginosis; Multicenter study; Lactobacillus rhamnosus; Lactobacillus gasseri
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Infections; Genital Diseases, Female; Bacterial Infections; Bacterial Infections and Mycoses; Vaginitis; Vaginal Diseases; Vaginosis, Bacterial
• Other Study ID Numbers: CTS-CO-2417 (Registry Identifier: ClinicalTrials.gov)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No