Chlorhexidine and/or Metronidazole Plus FB301 Pre-treatment Trial
ConditionBacterial Vaginosis (BV)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorFreya Biosciences ApS
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Premenopausal women aged 18 to 45 years of age inclusive, at the time of signing the informed consent.
Participants with an untreated suspected or confirmed symptomatic BV presenting with characteristic vaginal discharge and/or fishy odor confirmed by Gram stain of the vaginal specimen having a Nugent Score of equal or above 7 at the screening visit.
Participant is otherwise in good physical and mental health, as determined by the investigator
BMI up to 37 kg/m2 (inclusive)
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
FB 301
DrugFB 301 capsule
Chlorhexidine 0.5%
DrugVaginal cleanse with 0.5% Chlorhexidine solution
metronidazole 500 mg
DrugMetronidazole 500 mg tablets
Treatment groups
120 Participants
are divided into 4 treatment groupsGroup A: Metronidazole 500 mg plus intravaginal FB301Experimental treatment 2 interventions
Group B: single dose of 0.5% chlorhexidine solution followed by intravaginal FB301Experimental treatment 2 interventions
Group C: single dose of 0.5% chlorhexidine solution, oral metronidazole 500 mg then intravaginal FB301Experimental treatment 3 interventions
Group D: FB301Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
Baseline to visit 3 (week 3)Secondary outcomes
1
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).
Time frame
Visit 2 (Baseline) to visit 6 (week 10)2
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).
Time frame
Visit 2 Baseline to Visit 6 (week 10)Other outcomes
1
The change in vaginal microbiome in terms of relative abundance of Bifidobacterium species (previously Gardnerella species), Atopobium species, and Fannyhessea species.
The change in vaginal microbiome in terms of relative abundance of Bifidobacterium species (previously Gardnerella species), Atopobium species, and Fannyhessea species 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).
Time frame
Visit 2 (Baseline) to Visit 6 (week 10)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Freya Biosciences ApS
Lead sponsor
CRS Clinical Research Services Berlin GmbH
Collaborator
CRS Clinical Research Services Mannheim GmbH
Collaborator
Source ClinicalTrials.gov