Live Double Combined Lactobacillus Capsule for Vaginal Use（IIa）
brief 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.
official title
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