Vaginal Flora ImbalanceDYSCOVER-1NCT05114031
FB101 Intervention in Women Screened to Have Vaginal Dysbiosis
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 metagenomic sequencing of a vaginal swab sample. 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
- 34 participants
- Where
- 1 siteIreland
- Study dates
- 20 Oct 2021to 1 Feb 2023
- 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.
- Is generally healthy, as determined by the investigator.
- Free of self-reported vaginal symptoms.
- Pre-menopausal women.
- Meets the following pre-defined criteria of vaginal dysbiosis: Combined Lactobacilli relative abundance below 10 % AND combined relative abundance of Gardnerella + Atopobium + Prevotella above 20 % based on metagenomic sequencing of vaginal sample.
Show all 12Show fewer
- Has regular, predictable menstrual cycles of known length OR has been amenorrhoeic for at least 3 months due to use of a long-acting progestin or hormonal contraceptives.
- Is willing to be asked questions about personal medical, sexual, and behavioural history.
- Is willing to self-collect cervicovaginal secretions and vaginal swab samples at the clinic.
- Is willing to abstain from vaginal intercourse, unless using condoms, without the use of adjunctive spermicide or lubricant for at least one menstrual cycle length (28 days) after the intervention.
- Is willing to avoid taking baths, swimming, sitting in a hot tub, or wearing thong underwear for at least one menstrual cycle length (28 days) after the intervention.
- Is willing to abstain from using insertive vaginal feminine products (i.e., tampons, menstrual cups, sex toys), vaginal cleansing products, spermicides, lubricants, or other vaginal products not approved by the study investigators for at least 1 menstrual cycle length (28 days) after the intervention.
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.
- Participants currently of childbearing potential, but not using an effective method of contraception, as outlined below:
- Complete abstinence from intercourse two weeks prior to the intervention, throughout the clinical study, until the completion of follow-up procedures or for two weeks following discontinuation of the study participation in cases where participant discontinues the study prematurely. (Participants utilising this method must agree to use an alternate method of contraception if they should become sexually active and will be queried on whether they have been abstinent in the preceding 2 weeks when they present to the clinic for the Final Visit).
- Has a male sexual partner who is surgically sterilised prior to the Screening Visit and is the only male sexual partner for that participant.
- Use of acceptable method of contraception, such as a spermicide, mechanical barrier (e.g., male condom, female diaphragm), or contraceptive pill. The participant must be using this method for at least 1 week following the end of the study.
Show all 20Show fewer
- Use of any non-hormonal intrauterine device (IUD) or contraceptive implant with published data showing that the highest expected failure rate is less than 1 % per year. The participant must have the device inserted at least 3 months prior to the first Screening Visit, throughout the study, and 2 weeks following the end of the study.
- Women in same-sex relationships, or who are likely to engage in sexual relationships with other females throughout the study.
- Participants who have HIV/AIDS or other immunodeficiency.
- Participants who test positive at screening for HIV, chlamydia, gonorrhoea, Mycoplasma genitalium, and/or trichomonas vaginalis.
- Participants with a current vaginal candida infection, bacterial vaginosis or other condition requiring treatment that by the opinion of the investigator contraindicates participation in the current study.
- Participants may not be receiving treatment involving experimental drugs. If the participant has been in a recent experimental study, these must have been completed not less than 30 days prior to this study.
- Participants who have undergone some sort of procedure involving trauma to the cervix within the last 2 months 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 exam, which, in the opinion of the investigator, precludes participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: FB101 Intervention in Asymptomatic Healthy Volunteers Who Have Undergone Vaginal Microbiome Screening - a Randomised, Double-blind, Placebo-controlled 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 metagenomic sequencing 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 metagenomic sequencing of a vaginal swab sample. A dose of FB101 will be given on 3 different days and subjects will be followed for changes in their vaginal microbiomes until approximately 6 months after the first FD101 dose.
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 metagenomic sequencing. If, and when, all criteria are confirmed, a baseline visit, visit 2, is scheduled to be performed around day 8 of the following menstrual cycle of each individual subject. Besides baseline assessments, the subject is randomised to active FB101 or placebo in a ratio of 3(active): 1(placebo) and the first dose is given. At visit 3 and 4 (performed on day 9 and 10 in the same menstrual cycle as Visit 2) the following 2 doses are given.
In total, 7 follow-up visits (visit 5-11) are scheduled to occur for a period of up to 6 months after the first dose. All follow-up visits will be scheduled to occur around day 8 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, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FB101Other
Microbial intervention using product FB101
PlaceboOther
Saline water
| Study group | Role | What they receive |
|---|---|---|
| FB101 | Experimental | Active intervention with microbial product FB101 Receives: Other: FB101 |
| Placebo | Placebo comparator | Non-microbial placebo intervention Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in relative abundance of combined vaginal lactobacilli species
The change in vaginal microbiome in active FB101 arm versus placebo arm measured as changes in relative abundance of combined vaginal lactobacilli species measured by metagenomic sequencing of vaginal samples.
Measured: Comparing baseline (visit 2) to the following time points: 1 (visit 6), 2 (Visit 7), 3 (Visit 8), 4 (Visit 9), 5 (Visit 10) and 6 (Visit 11) months after Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2021
- Study start20 Oct 2021
- Primary completion15 Oct 2022
- Study completion1 Feb 2023
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, 2-arm, placebo-controlled study.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 34 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 Food Clinical Trials
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05114031
- Sponsor's protocol ID
- DYSCOVER-1
- Acronym
- DYSCOVER-1
- Status last verified
- Oct 2021
- First submitted
- 19 Oct 2021
- Last updated
- 3 May 2023
- 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 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FB101 Intervention in Asymptomatic Healthy Volunteers Who Have Undergone Vaginal Microbiome Screening - a Randomised, Double-blind, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT05114031
- Acronym / sponsor ID
- DYSCOVER-1 / DYSCOVER-1
- Conditions
- Vaginal Flora Imbalance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Freya Biosciences ApSIndustry (pharma, biotech, devices)
- Study start
- 20 Oct 2021 (actual)
- Primary completion
- 15 Oct 2022 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 9 Nov 2021 (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 metagenomic sequencing 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 metagenomic sequencing of a vaginal swab sample. A dose of FB101 will be given on 3 different days and subjects will be followed for changes in their vaginal microbiomes until approximately 6 months after the first FD101 dose.
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 metagenomic sequencing. If, and when, all criteria are confirmed, a baseline visit, visit 2, is scheduled to be performed around day 8 of the following menstrual cycle of each individual subject. Besides baseline assessments, the subject is randomised to active FB101 or placebo in a ratio of 3(active): 1(placebo) and the first dose is given. At visit 3 and 4 (performed on day 9 and 10 in the same menstrual cycle as Visit 2) the following 2 doses are given.
In total, 7 follow-up visits (visit 5-11) are scheduled to occur for a period of up to 6 months after the first dose. All follow-up visits will be scheduled to occur around day 8 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
- 2
- Model description
- Randomised, double-blind, parallel, 2-arm, placebo-controlled study.
| Arm | Type | Receives |
|---|---|---|
| FB101 | Experimental | Other: FB101Active intervention with microbial product FB101 |
| Placebo | Placebo comparator | Other: PlaceboNon-microbial placebo intervention |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Be able and willing to give written informed consent.
- Age between ≥18 to ≤45.
- Is generally healthy, as determined by the investigator.
- Free of self-reported vaginal symptoms.
- Pre-menopausal women.
Key exclusion criteria (20 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.
- Participants currently of childbearing potential, but not using an effective method of contraception, as outlined below:
- Women in same-sex relationships, or who are likely to engage in sexual relationships with other females throughout the study.
- Participants who have HIV/AIDS or other immunodeficiency.
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 |
|---|---|---|
| FB101Microbial intervention using product FB101 | Other | FB101 |
| PlaceboSaline water | Other | Placebo |
Primary outcome
Changes in relative abundance of combined vaginal lactobacilli species
Time frame: Comparing baseline (visit 2) to the following time points: 1 (visit 6), 2 (Visit 7), 3 (Visit 8), 4 (Visit 9), 5 (Visit 10) and 6 (Visit 11) months after Baseline
The change in vaginal microbiome in active FB101 arm versus placebo arm measured as changes in relative abundance of combined vaginal lactobacilli species 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 3 May 2023.
- 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 Food 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 12 inclusion and 20 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 3 May 2023. 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 combined vaginal lactobacilli species (time frame: Comparing baseline (visit 2) to the following time points: 1 (visit 6), 2 (Visit 7), 3 (Visit 8), 4 (Visit 9), 5 (Visit 10) and 6 (Visit 11) months after Baseline). 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 3 May 2023.