Not Yet RecruitingPhase 2

Chlorhexidine and/or Metronidazole Plus FB301 Pre-treatment Trial

Germany120 participantsStarted 2026-03-16

Plain-language 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.

Who can participate

Age range18 Years – 45 Years

SexFEMALE

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Exclusion criteria

✕. Known immunodeficiency conditions, including drug induced.
✕. Contraindication to metronidazole or chlorhexidine.
✕. Any known condition requiring regular use of antibiotics, which would suggest the likely requirement for antibiotic treatment during the trial.
✕. Any social, medical, or psychiatric condition that in the opinion of the Investigator would make it unlikely for the participant to comply with the trial requirements or might interfere with the objectives of the trial.
✕. History of drug or alcohol abuse that in the opinion of the Investigator would make it unlikely for the participant to comply with the trial or would complicate interpretation of data from participation.
✕. History of gynecological cancers, gynecological conditions, or surgical gynecological medical history which, in the opinion of the Investigator, precludes participation.
✕. Abnormal finding on the physical examination or gynecological examination or any other condition which, in the opinion of the Investigator, precludes participation.
✕. Patients with other infectious causes of vulvovaginitis (e.g., vulvovaginal candidiasis, Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae, or active Herpes simplex \[including PCR test positive\]).

What they're measuring

The change in vaginal microbiome in terms of relative abundance of combined Lactobacillus crispatus and jensenii species

Timeframe: Baseline to visit 3 (week 3)

Trial details

NCT IDNCT07481955

SponsorFreya Biosciences ApS

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-03-03

View on ClinicalTrials.gov More Bacterial Vaginosis (BV) trials