Clinical trials

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.

The goal of this clinical trial is to evaluate FB301 during a mock frozen embryo transfer (FET) cycle in pre-menopausal women aged 18 to 40 years with a prior failed FET and a defined vaginal bacterial imbalance (dysbiosis). The main question it aims to answer is: • Does treatment with FB301 during a mock FET cycle change the proportion of participants who meet the predefined vaginal bacterial threshold compared with placebo? Researchers will compare: * FB301 given after an initial vaginal cleansing with chlorhexidine (an antiseptic solution), * FB301 given after an initial vaginal cleansing with saline (saltwater), and * A placebo capsule given after an initial vaginal cleansing with saline to determine whether these approaches affect vaginal bacterial composition and pregnancy outcomes. Participants will take study treatment for 15 days during a "mock" FET cycle. In a mock cycle, participants receive the hormones needed to prepare the uterus for embryo transfer, but no embryo is transferred. After completing the mock cycle, participants will proceed with their planned frozen embryo transfer and will be followed during pregnancy until birth. Participants will: * Undergo a vaginal cleansing before receiving the first dose of FB301 or placebo * Provide vaginal swab samples at up to 5 study visits * Attend the study centre for up to 8 visits and participate in up to 4 follow-up phone calls * Complete a mock FET cycle before proceeding with their planned frozen embryo transfer cycle Participants who become pregnant will be followed until birth.