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Chlorhexidine and/or Metronidazole Plus FB301 Pre-treatment Trial

NCT07481955 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-03-20

No results posted yet for this study

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.

Conditions

  • Bacterial Vaginosis (BV)

Interventions

DRUG

FB 301

FB 301 capsule

DRUG

Chlorhexidine 0.5%

Vaginal cleanse with 0.5% Chlorhexidine solution

DRUG

metronidazole 500 mg

Metronidazole 500 mg tablets

Sponsors & Collaborators

  • Freya Biosciences ApS

    lead INDUSTRY

  • CRS Clinical Research Services Berlin GmbH

    collaborator UNKNOWN

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-16
Primary Completion
2027-03-03
Completion
2027-04-21

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07481955 on ClinicalTrials.gov