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Live Double Combined Lactobacillus Capsule for Vaginal Use（IIa）

NCT07418996 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2026-02-18

No results posted yet for this study

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)

Interventions

DRUG

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

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

DRUG

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

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

DRUG

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

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

DRUG

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

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

DRUG

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

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

DRUG

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

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

Sponsors & Collaborators

  • Guangdong Longchuangji Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-18
Primary Completion
2022-07-04
Completion
2022-09-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07418996 on ClinicalTrials.gov