Chlorhexidine and/or Metronidazole Plus FB301 Pre-treatment Trial
brief summary
The goal of this study is to evaluate how treatment with FB301 affects the balance of vaginal bacteria in women (aged 18-45) with bacterial vaginosis after pre-treatment with either a vaginal antiseptic wash (chlorhexidine), an oral antibiotic (metronidazole), or both. The main question it aims to answer is: Does treatment with FB301, with or without pre-treatment using a vaginal antiseptic (chlorhexidine) or an oral antibiotic (metronidazole), change the balance of vaginal bacteria, measured by the proportion of two key bacteria (Lactobacillus crispatus and Lactobacillus jensenii), between the start of treatment and follow-up visits over the next 10 weeks? Researchers will compare participants randomly assigned to 4 different groups: * Group 1 will receive FB301for 15 days with the antibiotic (metronidazole) for the first seven days. In the next menstrual cycle, they will receive just FB301 for an additional 15-days. * Group 2 will receive FB301for 15 days. On the first day only, they will first undergo a vaginal cleanse with chlorhexidine (antiseptic solution). In the next menstrual cycle, they will receive just FB301 for an additional 15-days. * Group 3 will receive FB301for 15 days with the antibiotic (metronidazole) for the first seven days. On the first day only, they will first undergo a vaginal cleanse with chlorhexidine (antiseptic solution). In the next menstrual cycle, they will receive FB301 for an additional 15-days following a vaginal cleanse with chlorhexidine (antiseptic solution) on the first day only. * Group 4 will receive just FB301for 15 days. In the next menstrual cycle, they will receive just FB301 for an additional 15-days. Participants will: * Attend the study centre for up to 6 visits * Provide vaginal swab samples at up to 6 visits * Provide vaginal secretion samples using a menstrual disc at up to 4 visits * Have blood samples taken at up to 6 visits * Receive the study treatments for the randomly assigned group over two consecutive menstrual cycles.
detailed description
Bacterial vaginosis is a dysbiosis of vaginal microbiota characterized by a shift from Lactobacillus dominance to that of communities of various mostly anaerobic bacteria. It is the most common vaginal disorder worldwide in women of childbearing age presenting with a range of clinical features from asymptomatic to an increase in vaginal discharge with or without the characteristic fishy odour. In addition, it is a risk factor for and/or associated with worse outcomes in sexually transmitted infections, reproduction and immune-driven diseases of the female reproductive tract.
During the trial, the participants will either receive, (1) FB301, a Live Biotherapeutic Product (LBP) comprising consortia of Lactobacillus strains, together with oral antibiotic treatment metronidazole, (2) FB301 following vaginal antisepsis with 0.5% chlorhexidine solution, (3) FB301 together with oral antibiotic treatment metronidazole following vaginal antisepsis with 0.5% chlorhexidine solution or (4) FB301. In addition, all participants will receive FB301in a second treatment cycle, either alone (Groups 1,2 and 4) or following a second vaginal antisepsis with 0.5% chlorhexidine solution in Group 3.
Treatment Group 1:
Oral metronidazole 500 mg twice daily for 7 days starting 1 day after menses, plus intravaginal FB301 once daily for 15 days, followed by a second course of intravaginal FB301 once daily for additional 15 days starting 1 day after menses.
Treatment Group 2:
Intravaginal antisepsis with a single dose of 0.5% chlorhexidine solution 1 day after menses, then intravaginal FB301 once daily for 15 days, followed by second course of intravaginal FB301 once daily for additional 15 days starting immediately after the next menstrual cycle.
Treatment Group 3:
Intravaginal antisepsis with a single dose of 0.5% chlorhexidine solution 1 day after menses, then oral metronidazole 500 mg twice daily for 7 days and intravaginal FB301 once daily for 15 days, followed by second intravaginal antisepsis with a single dose of 0.5% chlorhexidine solution then a second course of intravaginal FB301 once daily for additional 15 days 1 day after menses.
Treatment Group 4:
Intravaginal FB301 once daily for 15 days starting 1 day after menses, followed by second course of intravaginal FB301 once daily for additional 15 days 1 day after menses
official title
Open-label Safety and Efficacy Trial of Chlorhexidine and/or Metronidazole Pre-treatment Followed by FB301 in Women With Bacterial Vaginosis