NCT07418996

Live Double Combined Lactobacillus Capsule for Vaginal Use（IIa）

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Guangdong Longchuangji Pharmaceutical Co., Ltd. · Industry
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Bacterial Vaginosis (BV)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-05-18
• Primary completion: 2022-07-04
• Completion: 2022-09-30
• First posted: 2026-02-18
• Last updated: 2026-02-18

Locations

1 site across 1 country: China