Study of FB301 Treatment With or Without Chlorhexidine or Metronidazole Pre-treatment in Women Aged 18 to 45 With Bacterial Vaginosis

What this Trial Is About

This research aims to evaluate how treatment with FB301 affects the balance of vaginal bacteria in women aged 18 to 45 who have bacterial vaginosis. The study compares the effects of FB301 alone or combined with pre-treatment using either a vaginal antiseptic wash chlorhexidine, an oral antibiotic metronidazole, or both. The main focus is on changes in key vaginal bacteria, Lactobacillus crispatus and Lactobacillus jensenii, over a 10-week period after treatment. Participants are randomly assigned to one of four groups Group 1 receives FB301 with metronidazole for 15 days followed by FB301 alone in the next menstrual cycle Group 2 receives a vaginal cleanse with chlorhexidine before FB301 treatment and then FB301 alone in the next cycle Group 3 receives chlorhexidine, metronidazole, and FB301, followed by a second chlorhexidine cleanse and FB301 Group 4 receives only FB301 throughout. Treatments are given over two consecutive menstrual cycles with specific dosing schedules detailed for each group. Throughout the study, participants attend up to six visits at the study center. They provide vaginal swabs and vaginal secretion samples using a menstrual disc at several visits, and blood samples at up to six visits. Researchers monitor changes in the vaginal microbiome, safety, and tolerability of FB301 with or without pre-treatment. The primary outcome measures focus on the relative abundance of Lactobacillus species from baseline to week 3 and through week 10. Participation lasts across the two treatment cycles and follow-up assessments.

Chlorhexidine and/or Metronidazole Plus FB301 Pre-treatment Trial