Bacterial Vaginosis (BV)Phase 2NCT07481955
Chlorhexidine and/or Metronidazole Plus FB301 Pre-treatment Trial
A Phase 2 study testing FB 301, Chlorhexidine 0.5% and metronidazole 500 mg in people with Bacterial Vaginosis (BV), run by Freya Biosciences ApS at 2 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Bacterial Vaginosis (BV)
- What is being tested?
- FB 301, Chlorhexidine 0.5% and metronidazole 500 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesGermany
- Study dates
- 23 Mar 2026to 21 Apr 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
None listed.
Who cannot join
- 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.
Show all 26Show fewer
- 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]).
- Patients with another vaginal or vulvar condition, which would confound the interpretation of clinical response.
- Participants taking prescription or non-prescription drugs (including vitamins and dietary or herbal supplements) within 2 weeks or 5 half-lives (whichever is longer) before the start of trial treatment (unless, in the opinion of the Investigator and Sponsor, the medication will not interfere with the trial).
- Receiving treatment involving investigational drugs. Any previous investigational drug must have been completed at least 30 days prior to screening in this trial.
- Systemic and/or vaginally applied antibiotic use within the last 30 days prior to screening.
- Participants who are currently receiving antibacterial therapy unrelated to BV.
- Clinical laboratory test results which are clinically unacceptable at screening. Any clinically significant abnormal urinalysis should be repeated. If then confirmed abnormal and clinically significant, participant should be excluded. Any clinically significant out of range chemistry or hematology values should exclude the participant.
- Positive serum HBsAg (other than vaccination related), HCV and HIV antibody tests at screening.
- Positive test for Treponema pallidum (syphilis).
- Clinically relevant abnormalities in blood pressure and pulse rate (as assessed by the Investigator).
- Aural body temperature of < 35.5 or > 37.6°C at screening
- Pregnant, breastfeeding, has been pregnant within the last 2 months, or wishes to become pregnant within the next 6 months. Egg donation during the trial is not permitted.
- Use of a copper IUD (intrauterine device) within 12 weeks of screening. (Hormonal IUDs are permitted.)
- Use of probiotics, prebiotics or symbiotics (supplements and products, oral or vaginal) within past 30 days. (NOTE: Oral yogurt with live cultures is allowed, as are fermented foods)
- Donation of more than 100 mL whole blood or plasma within 4 weeks before start of treatment or more than 500 mL of whole blood 3 months before start of treatment or intended blood donation during the trial.
- History of alcohol or substance dependency.
- Employee of the Sponsor, the CRS Group, or other CRO involved in the clinical trial.
- Any other conditions or factors which in the opinion of the Investigator may interfere with trial conduct.
- -
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany2 sites, 2 recruiting
- Recruiting
CRS Clinical Research Services Berlin GmbH
Berlin, State of Berlin, 13627
Matthias Berse, MD, +49 30 859949120, Matthias.Berse@crs-group.de
- Recruiting
CRS Clinical Research Services Mannheim
Mannheim
Jolanta Wierdak, MD, +49 621 15045 124, j.wierdak@hvivo.de
About this study
Official title: Open-label Safety and Efficacy Trial of Chlorhexidine and/or Metronidazole Pre-treatment Followed by FB301 in Women With Bacterial Vaginosis
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:
Read more
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.
Read the 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
The primary objective is to assess the impact on change in vaginal microbiome in terms of relative abundance of combined Lactobacillus species with chlorhexidine vaginal antisepsis (0.5%) and/or oral metronidazole pre-treatment followed by administration of FB301 in women with bacterial vaginosis.
Secondary objectives are to assess the safety and tolerability of FB301 with chlorhexidine vaginal antisepsis (0.5%) and/or oral metronidazole pre-treatment followed by administration of FB301 in women with bacterial vaginosis and to assess the impact on rate of cure of bacterial vaginosis with chlorhexidine vaginal antisepsis (0.5%) and/or oral metronidazole pre-treatment followed by administration of FB301 in women with bacterial vaginosis.
- Conditions
- Bacterial Vaginosis (BV)
- Being tested
- FB 301, Chlorhexidine 0.5%, metronidazole 500 mg
- Medical subject headings
- Vaginosis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FB 301Drug
FB 301 capsule
Chlorhexidine 0.5%Drug
Vaginal cleanse with 0.5% Chlorhexidine solution
metronidazole 500 mgDrug
Metronidazole 500 mg tablets
| Study group | Role | What they receive |
|---|---|---|
| Metronidazole 500 mg plus intravaginal FB301 | Experimental | 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 Receives: Drug: FB 301; Drug: metronidazole 500 mg |
| single dose of 0.5% chlorhexidine solution followed by intravaginal FB301 | Experimental | 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. Receives: Drug: FB 301; Drug: Chlorhexidine 0.5% |
| single dose of 0.5% chlorhexidine solution, oral metronidazole 500 mg then intravaginal FB301 | Experimental | 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 Receives: Drug: FB 301; Drug: Chlorhexidine 0.5%; Drug: metronidazole 500 mg |
| FB301 | Experimental | 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 Receives: Drug: FB 301 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in vaginal microbiome in terms of relative abundance of combined Lactobacillus crispatus and jensenii species
Metagenomic sequencing is performed on cervical vaginal swab samples. Relative abundance is expressed as a percentage of bacterial sequencing reads that are assigned to a specific bacterial species. The change in vaginal microbiome in terms of relative abundance of combined Lactobacillus crispatus and jensenii species measured by metagenomic sequencing of vaginal samples obtained from Visit 2 (Baseline) to Visit 3 (Week 3).
Measured: Baseline to visit 3 (week 3)
Secondary outcomes (2)
The change in vaginal microbiome in terms of relative abundance of combined Lactobacillus crispatus and jensenii species.
The change in vaginal microbiome in terms of relative abundance of combined Lactobacillus crispatus and jensenii species, measured by metagenomic sequencing in vaginal samples from Visit 2 (Baseline) to Visit4 (Week 5), Visit 5 (Week 7), and Visit 6 (Week10).
Measured: Visit 2 (Baseline) to visit 6 (week 10)
The change in vaginal microbiome in terms of relative abundance of combined vaginal Lactobacillus crispatus, jensenii, mulieris, gasseri and paragasseri
The change in vaginal microbiome in terms of relative abundance of combined vaginal Lactobacillus crispatus, jensenii, mulieris, gasseri and paragasseri measured by metagenomic sequencing in vaginal samples from Visit 2 (Baseline) to Visit 3 (Week 3), Visit 4 (Week 5), Visit 5 (Week 7), and Visit 6 (Week 10).
Measured: Visit 2 Baseline to Visit 6 (week 10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start23 Mar 2026
- Primary completion3 Mar 2027 (estimated)
- Study completion21 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial Vaginosis (BV)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Freya Biosciences ApS
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CRS Clinical Research Services Berlin GmbH, CRS Clinical Research Services Mannheim GmbH
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07481955
- Sponsor's protocol ID
- FRB-004
- Other IDs
- 2025-524362-20, 2025
- Status last verified
- Aug 2026
- First submitted
- 15 Mar 2026
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are no current plans to share individual participant data.
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label Safety and Efficacy Trial of Chlorhexidine and/or Metronidazole Pre-treatment Followed by FB301 in Women With Bacterial Vaginosis
- ClinicalTrials.gov ID
- NCT07481955
- Acronym / sponsor ID
- FRB-004
- Conditions
- Bacterial Vaginosis (BV)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Freya Biosciences ApSIndustry (pharma, biotech, devices)
- Collaborators
- CRS Clinical Research Services Berlin GmbH, CRS Clinical Research Services Mannheim GmbH
- Study start
- 23 Mar 2026 (actual)
- Primary completion
- 3 Mar 2027 (estimated)
- Study completion
- 21 Apr 2027 (estimated)
- First posted
- 19 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
The primary objective is to assess the impact on change in vaginal microbiome in terms of relative abundance of combined Lactobacillus species with chlorhexidine vaginal antisepsis (0.5%) and/or oral metronidazole pre-treatment followed by administration of FB301 in women with bacterial vaginosis.
Secondary objectives are to assess the safety and tolerability of FB301 with chlorhexidine vaginal antisepsis (0.5%) and/or oral metronidazole pre-treatment followed by administration of FB301 in women with bacterial vaginosis and to assess the impact on rate of cure of bacterial vaginosis with chlorhexidine vaginal antisepsis (0.5%) and/or oral metronidazole pre-treatment followed by administration of FB301 in women with bacterial vaginosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Metronidazole 500 mg plus intravaginal FB301 | Experimental | Drug: FB 301, Drug: metronidazole 500 mgOral 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 |
| single dose of 0.5% chlorhexidine solution followed by intravaginal FB301 | Experimental | Drug: FB 301, Drug: Chlorhexidine 0.5%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. |
| single dose of 0.5% chlorhexidine solution, oral metronidazole 500 mg then intravaginal FB301 | Experimental | Drug: FB 301, Drug: Chlorhexidine 0.5%, Drug: metronidazole 500 mgIntravaginal 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 |
| FB301 | Experimental | Drug: FB 301Intravaginal 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (26 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FB 301FB 301 capsule | Drug | FB301, Metronidazole 500 mg plus intravaginal FB301, single dose of 0.5% chlorhexidine solution followed by intravaginal FB301, single dose of 0.5% chlorhexidine solution, oral metronidazole 500 mg then intravaginal FB301 |
| Chlorhexidine 0.5%Vaginal cleanse with 0.5% Chlorhexidine solution | Drug | single dose of 0.5% chlorhexidine solution followed by intravaginal FB301, single dose of 0.5% chlorhexidine solution, oral metronidazole 500 mg then intravaginal FB301 |
| metronidazole 500 mgMetronidazole 500 mg tablets | Drug | Metronidazole 500 mg plus intravaginal FB301, single dose of 0.5% chlorhexidine solution, oral metronidazole 500 mg then intravaginal FB301 |
Primary outcome
The change in vaginal microbiome in terms of relative abundance of combined Lactobacillus crispatus and jensenii species
Time frame: Baseline to visit 3 (week 3)
Metagenomic sequencing is performed on cervical vaginal swab samples. Relative abundance is expressed as a percentage of bacterial sequencing reads that are assigned to a specific bacterial species. The change in vaginal microbiome in terms of relative abundance of combined Lactobacillus crispatus and jensenii species measured by metagenomic sequencing of vaginal samples obtained from Visit 2 (Baseline) to Visit 3 (Week 3).
2 secondary outcomes
The change in vaginal microbiome in terms of relative abundance of combined Lactobacillus crispatus and jensenii species.
Time frame: Visit 2 (Baseline) to visit 6 (week 10)
The change in vaginal microbiome in terms of relative abundance of combined vaginal Lactobacillus crispatus, jensenii, mulieris, gasseri and paragasseri
Time frame: Visit 2 Baseline to Visit 6 (week 10)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Individual participant dataSharing planned: No. There are no current plans to share individual participant data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
CRS Clinical Research Services Berlin GmbH
Berlin, Germany
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FB 301, Chlorhexidine 0.5% and metronidazole 500 mg in people with Bacterial Vaginosis (BV), run by Freya Biosciences ApS at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in vaginal microbiome in terms of relative abundance of combined Lactobacillus crispatus and jensenii species (time frame: Baseline to visit 3 (week 3)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.