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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
57
Live double combined lactobacillus capsule for vaginal use(1\*10\^7CFU/capsule)+Metronidazole placebo, double-blind, double-dummy administration regimen
Low-dose group:Live double combined lactobacillus capsule placebo+Metronidazole, double-blind, double-dummy administration regimen.
Guangdong Longchuangji Pharmaceutical Co., Ltd.
Chaozhou, Guangdong, China
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.
Time frame: 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.
Time frame: Through study completion, an average of 30 days
Cure rate of bacterial vaginosis in subjects
Time frame: Day 12 to Day 16
Recurrence rate of bacterial vaginosis in subjects
Recurrence rate at Day 25 to Day 31
Time frame: Day 25 to Day 31
Cure rate of bacterial vaginosis in subjects
Time frame: Day 25 to Day 31
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Live double combined lactobacillus capsule for vaginal use(1\*10\^8CFU/capsule)+Metronidazole placebo, double-blind, double-dummy administration regimen
Medium-dose group: Live double combined lactobacillus capsule placebo+Metronidazole, double-blind, double-dummy administration regimen
Live double combined lactobacillus capsule for vaginal use(1\*10\^9CFU/capsule)+Metronidazole placebo, double-blind, double-dummy administration regimen.
High-dose group: Live double combined lactobacillus capsule placebo+Metronidazole, double-blind, double-dummy administration regimen.