Vaginal Flora ImbalanceDyscover-3NCT05850078
FB101 Intervention in Women Screened to Have Vaginal Dysbiosis (Dyscover-3)
A study testing FB101 in people with Vaginal Flora Imbalance, run by Freya Biosciences ApS at 1 site in Ireland.
Trial summary
This study will explore and map the potential shifts in vaginal microbiomes as a consequence of a microbial intervention with product FB101 in healthy, asymptomatic volunteer women screened to have vaginal dysbiosis based on criteria defined by quantitative polymerase chain reaction (qPCR) analysis of a vaginal swab… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaginal Flora Imbalance
- What is being tested?
- FB101
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 97 participants
- Where
- 1 siteIreland
- Study dates
- 18 May 2023to 24 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Be able and willing to give written informed consent.
- Age between ≥18 to ≤45.
- Be generally healthy, as determined by the investigator.
- Be a pre-menopausal woman.
- Meet the following definition of vaginal dysbiosis: combined copy number of Lactobacillus species crispatus, gasseri, and jensenii measured by qPCR, corresponding to less than 10% total relative abundance of Lactobacillus species crispatus, gasseri, and jensenii as measured by metagenomic sequencing.
- Have regular, predictable menstrual cycles of known length or have been amenorrhoeic for at least 3 months due to use of a long-acting progestin or hormonal contraceptives.
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- Be willing to be asked questions about personal medical, sexual, and behavioural history.
- Be willing to undergo two vaginal microbiome transplant procedures.
- Be willing to self-collect cervicovaginal secretions and vaginal swab samples.
- Be willing to use one of the following effective methods of contraception throughout the clinical study:
- Complete abstinence from vaginal intercourse.
- Have a male sexual partner who is surgically sterilised prior to the screening visit and is the only male sexual partner for that participant.
- Mechanical barrier (condom or diaphragm), or hormone contraception (contraceptive pill, injections, implant or patch).
- Be willing to completely abstain from vaginal intercourse and receptive oral sex during the eight days from visit 4 (first FB101 dose) to visit 6 (first follow-up).
- Be willing to abstain from vaginal intercourse, unless using condoms free from adjunctive spermicide or lubricant (with a male partner) or dental dams (with a female partner), and receptive oral sex, unless using dental dams, in the time period between visit 3 and visit 8.
- Be willing to avoid taking baths, swimming, or sitting in a hot tub in the time period between visit 3 and visit 8.
- Be willing to abstain from using insertive vaginal feminine products (i.e., tampons, menstrual cups), vaginal cleansing products, spermicides, lubricants, or other vaginal products not approved by the study investigators, and any penetration using fingers or sex toys into the vagina, in the time period between visit 3 and visit 8.
Who cannot join
- Participants who are post-menopausal, defined as more than 12 consecutive months of amenorrhea without another known cause than use of long-acting progestin or hormonal contraceptives.
- Participants who are pregnant, breastfeeding and/or have been pregnant within the last two months.
- Users of any hormonal or non-hormonal intrauterine device (IUD).
- Participants who have HIV/AIDS or other immunodeficiency.
- Participants who test positive at screening for HIV, chlamydia, gonorrhoea, Mycoplasma genitalium, and/or Trichomonas vaginalis. Potential participants may be re-screened if they receive successful treatment at their own medical provider.
- Participants who have received treatment involving experimental drugs less than 30 days prior to this study.
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- Participants who have undergone some sort of procedure involving trauma to the cervix within the last month prior to screening (i.e., IUD removal, cervical cryotherapy, or cervical laser treatment).
- Participants with any known condition requiring regular use of antibiotics, that would suggest the participant is likely to require antibiotic treatment during the study.
- Systemic and/or vaginally applied antibiotic use within the last month prior to screening.
- Participants with new (<3 months) use of long-acting hormonal treatments. Participant may be enrolled if stable (>3 months) or existing therapy as determined by the investigator.
- Participants with any social, medical, or psychiatric condition that in the opinion of the investigator would make it unlikely for the participant to comply with the study or would complicate interpretation of data from her participation.
- Participants with a history of drug or alcohol abuse that in the opinion of the investigator would make it unlikely for the participant to comply with the study or would complicate interpretation of data from her participation.
- Participants with a history of gynaecological cancers, gynaecological conditions, or surgical gynaecological medical history, which, in the opinion of the investigator, precludes participation.
- Participants with abnormal finding on screening examination, which, in the opinion of the investigator, precludes participation.
- Participants with clinically relevant abnormalities in the cervix or uterine cavity that could interfere with the collection of endometrial fluid.
- Participants with history of hypersensitivity/allergic reactions to the antiseptic active component or its ingredients.
- Participants who have previously received FB101 as part of a clinical study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vaginal Microbiome Transplant in Asymptomatic Healthy Volunteers, Who Have Undergone Vaginal Microbiome Screening - a Randomised, Double-blind, Placebo-controlled Three-arm Study
This study will explore and map the potential shifts in vaginal microbiomes as a consequence of a microbial intervention with product FB101 in healthy, asymptomatic volunteer women screened to have vaginal dysbiosis based on criteria defined by quantitative polymerase chain reaction (qPCR) analysis of a vaginal swab sample.
Read the detailed description
This study will explore and map the potential shifts in vaginal microbiomes as a consequence of a microbial intervention with product FB101 in healthy, asymptomatic volunteer women screened to have vaginal dysbiosis based on criteria defined by qPCR analysis of a vaginal swab sample. A dose of FB101 will be given on 2 different days and subjects will be followed for changes in their vaginal microbiomes until approximately 3 months after the first FB101 dose. Two different dilutions will be tested of FB101 in 2 different active arms. The study will also have a third arm receiving placebo product. In addition, an antiseptic vaginal wash will be performed before the first dose of FB101/placebo in all 3 study arms. Randomisation ratios will be 1:1:1.
The study includes a screening visit where all criteria for participation are checked and a vaginal swab is obtained to check if pre-defined dysbiosis criteria are met based on qPCR analysis of key vaginal bacterial species. If, and when, all criteria are confirmed, a baseline visit is scheduled to be performed around day 14 in the same menstrual cycle of each individual subject. Besides baseline assessments, the subject is randomised to active FB101 or placebo in a ratio of 1(active, FB101):1(active, diluted FB101): 1(placebo) and the first dose is given. At visit 3 (performed the day after baseline visit the following dose is given.
In total, 5 follow-up visits are scheduled to occur for a period of up to 3 months after the first dose. All follow-up visits will be scheduled to occur around day 14 in the subject's menstrual cycle with one menstrual cycle in between visits. At follow up visits, close safety monitoring will be performed as well as metagenomic sequencing assessment of the microbiota in a vaginal swab.
- Conditions
- Vaginal Flora Imbalance
- Being tested
- FB101
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FB101Other
Intervention will test effects on changes to the vaginal microbiome of FB101 versus diluted FB101 versus placebo
| Study group | Role | What they receive |
|---|---|---|
| FB101 | Experimental | Microbial intervention using product FB101 Receives: Other: FB101 |
| FB101 diluted | Experimental | Microbial intervention using diluted FB101 Receives: Other: FB101 |
| Placebo | Placebo comparator | Saline water Receives: Other: FB101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in relative abundance of vaginal lactobacilli species
The change in vaginal microbiome of the active arm participants (FB101 and diluted FB101) versus placebo participants in terms of the combined relative abundance of the vaginal Lactobacillus species crispatus, gasseri and jensenii measured by metagenomic sequencing of vaginal samples.
Measured: from baseline to 2 months after first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study start18 May 2023
- Primary completion29 Aug 2024
- Study completion24 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal Flora ImbalanceStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised, double-blind, parallel, 3-arm, placebo-controlled study.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Freya Biosciences ApS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fergus McCarthy, PhD, MD, Principal investigator, Atlantia Clinical Trials
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05850078
- Sponsor's protocol ID
- Dyscover-3
- Acronym
- Dyscover-3
- Status last verified
- Dec 2025
- First submitted
- 28 Apr 2023
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaginal Microbiome Transplant in Asymptomatic Healthy Volunteers, Who Have Undergone Vaginal Microbiome Screening - a Randomised, Double-blind, Placebo-controlled Three-arm Study
- ClinicalTrials.gov ID
- NCT05850078
- Acronym / sponsor ID
- Dyscover-3 / Dyscover-3
- Conditions
- Vaginal Flora Imbalance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Freya Biosciences ApSIndustry (pharma, biotech, devices)
- Study start
- 18 May 2023 (actual)
- Primary completion
- 29 Aug 2024 (actual)
- Study completion
- 24 Jan 2025 (actual)
- First posted
- 9 May 2023 (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.
This study will explore and map the potential shifts in vaginal microbiomes as a consequence of a microbial intervention with product FB101 in healthy, asymptomatic volunteer women screened to have vaginal dysbiosis based on criteria defined by quantitative polymerase chain reaction (qPCR) analysis of a vaginal swab sample.
Detailed description
This study will explore and map the potential shifts in vaginal microbiomes as a consequence of a microbial intervention with product FB101 in healthy, asymptomatic volunteer women screened to have vaginal dysbiosis based on criteria defined by qPCR analysis of a vaginal swab sample. A dose of FB101 will be given on 2 different days and subjects will be followed for changes in their vaginal microbiomes until approximately 3 months after the first FB101 dose. Two different dilutions will be tested of FB101 in 2 different active arms. The study will also have a third arm receiving placebo product. In addition, an antiseptic vaginal wash will be performed before the first dose of FB101/placebo in all 3 study arms. Randomisation ratios will be 1:1:1.
The study includes a screening visit where all criteria for participation are checked and a vaginal swab is obtained to check if pre-defined dysbiosis criteria are met based on qPCR analysis of key vaginal bacterial species. If, and when, all criteria are confirmed, a baseline visit is scheduled to be performed around day 14 in the same menstrual cycle of each individual subject. Besides baseline assessments, the subject is randomised to active FB101 or placebo in a ratio of 1(active, FB101):1(active, diluted FB101): 1(placebo) and the first dose is given. At visit 3 (performed the day after baseline visit the following dose is given.
In total, 5 follow-up visits are scheduled to occur for a period of up to 3 months after the first dose. All follow-up visits will be scheduled to occur around day 14 in the subject's menstrual cycle with one menstrual cycle in between visits. At follow up visits, close safety monitoring will be performed as well as metagenomic sequencing assessment of the microbiota in a vaginal swab.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomised, double-blind, parallel, 3-arm, placebo-controlled study.
| Arm | Type | Receives |
|---|---|---|
| FB101 | Experimental | Other: FB101Microbial intervention using product FB101 |
| FB101 diluted | Experimental | Other: FB101Microbial intervention using diluted FB101 |
| Placebo | Placebo comparator | Other: FB101Saline water |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- Be able and willing to give written informed consent.
- Age between ≥18 to ≤45.
- Be generally healthy, as determined by the investigator.
- Be a pre-menopausal woman.
- Meet the following definition of vaginal dysbiosis: combined copy number of Lactobacillus species crispatus, gasseri, and jensenii measured by qPCR, corresponding to less than 10% total relative abundance of Lactobacillus species crispatus, gasseri, and jensenii as measured by metagenomic sequencing.
Key exclusion criteria (17 listed)
- Participants who are post-menopausal, defined as more than 12 consecutive months of amenorrhea without another known cause than use of long-acting progestin or hormonal contraceptives.
- Participants who are pregnant, breastfeeding and/or have been pregnant within the last two months.
- Users of any hormonal or non-hormonal intrauterine device (IUD).
- Participants who have HIV/AIDS or other immunodeficiency.
- Participants who test positive at screening for HIV, chlamydia, gonorrhoea, Mycoplasma genitalium, and/or Trichomonas vaginalis. Potential participants may be re-screened if they receive successful treatment at their own medical provider.
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 |
|---|---|---|
| FB101Intervention will test effects on changes to the vaginal microbiome of FB101 versus diluted FB101 versus placebo | Other | FB101, FB101 diluted, Placebo |
Primary outcome
Changes in relative abundance of vaginal lactobacilli species
Time frame: from baseline to 2 months after first dose
The change in vaginal microbiome of the active arm participants (FB101 and diluted FB101) versus placebo participants in terms of the combined relative abundance of the vaginal Lactobacillus species crispatus, gasseri and jensenii measured by metagenomic sequencing of vaginal samples.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Vaginal Flora Imbalance
Active, not recruitingObservational study
Vaginal Microbiome and HPV Pre-malignant and Cervical Dysplasia
Human Papilloma Virus, Vaginal Flora Imbalance
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. This study is not recruiting at the moment.
Fergus McCarthy, PhD, MD principal investigator
Atlantia Clinical Trials
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FB101 in people with Vaginal Flora Imbalance, run by Freya Biosciences ApS at 1 site in Ireland.
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 17 inclusion and 17 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: finished, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in relative abundance of vaginal lactobacilli species (time frame: from baseline to 2 months after first dose). 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 10 Dec 2025.