Vaginal Personal CareNCT05659745
Randomized, Double-blind, Placebo-controlled Trial Investigating the Role of a Personal Care Product on Vaginal Health
A study testing VM-02 and Commercial Oral Probiotic Competitor in people with Vaginal Personal Care, run by Seed Health at 1 site in United States.
Trial summary
The goal of this clinical trial is to assess the impact of a personal care product on vaginal health in a healthy participant population. The personal care product, VM-02, contains a prebiotic, postbiotic, and three distinct strains of Lactobacillus crispatus, a microbe commonly found in healthy females, together… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaginal Personal Care
- What is being tested?
- VM-02 and Commercial Oral Probiotic Competitor
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Dec 2022to 15 May 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Reproductive age women aged ≥ 18.
- History of regular menses every 21-35 days for six months prior to the study.
- Agreement not to use specified intra-vaginal products during the study product use.
- Willing to use an intra-vaginal suppository or dietary supplement during the study period.
- Willing to complete vaginal swabs on themselves as directed in the study.
- Ability to understand and read English and provide written consent.
Who cannot join
- Pregnancy or planned pregnancy in the next 6 months.
- Two or more amenorrheic months in the past 6 months.
- Lives in the state of New York.
- Allergy to any components of the supporting or excipient ingredients in test formulation capsules, tablets, placebos or over-the-counter competitor product.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical trial is to assess the impact of a personal care product on vaginal health in a healthy participant population. The personal care product, VM-02, contains a prebiotic, postbiotic, and three distinct strains of Lactobacillus crispatus, a microbe commonly found in healthy females, together accounting for greater than 85% of known genes in this species. The intervention will be compared to a placebo intervention and will aim to assess the following in a healthy female population:
Measure changes in the relative and absolute abundance of a bacterial species, Lactobacillus crispatus, in the vagina, compared the baseline (prior to use of the personal care product) to two time points after use.
Read more
Observe changes in vaginal pH and self-reported discomfort from vaginal odor, compared the baseline to two time points after use.
Determine the user experience of three variations of a personal care product administered in different formats to improve vaginal health and establish tolerability and user acceptability.
Participants will use the personal care product according to a specific program as directed, conduct vaginal swab sampling, and answer questionnaires, each at eight time points.
Read the detailed description
The vaginal microbiome is a dynamic microecosystem that undergoes fluctuations during the female menstrual cycle and at various life stages from puberty to menopause. A healthy vaginal microbiome is dominated by Lactobacillus which regulates vaginal pH, produces antimicrobial compounds, and significantly influences host immune response. The purpose of this study is to determine whether vaginal health can be influenced by a novel personal care product comprised of a Lactobacillus postbiotic, prebiotic, and multiple strains of Lactobacillus crispatus predictive of a stable vaginal microbiome.
This study will be a randomized double-blind, placebo-controlled intervention that will examine the safety and tolerability of a personal care product for vaginal health, VM-02. This pilot study will last for the duration of two complete menstrual cycles. Data will be collected via participant virtual questionnaires and vaginal swabs.
Participants are randomized as follows:
A two-arm randomized, double-blind, placebo-controlled study to evaluate VM-02 as a vaginal suppository capsule.
Arm #1: Vaginal application of single-use applicators filled with a vaginal suppository capsule at 5 x 10^8 CFU/dose. The study product will be administered once daily for 7 consecutive days, followed by once weekly application over 2 consecutive additional weeks.
Arm #2: Vaginal application of single-use applicators filled with a vaginal suppository placebo capsule. The study product will be administered once daily for 7 consecutive days, followed by once weekly application over 2 consecutive additional weeks.
Three additional arms are included to quantify the impact of an alternative formulation and user experience.
Arm #3: Vaginal application of single-use applicators filled with vaginal suppository tablet at 5 x 10^8 CFU/dose. The study product will be administered on Days 1,4,7,14,21.
Arm #4: Oral administration of capsule at 5 x 10^8 cfu/dose. The study product will be administered daily for 30 consecutive days.
Arm #5: Oral administration of commercially available over-the-counter oral capsule at 5 x 10^8 CFU/dose. The study product will be administered daily for 30 consecutive days.
Colonization rate of 3 distinct Lactobacillus crispatus after administration of VM-02 will be assessed with PCR and DNA sequence analysis.
Researchers will compare groups who received active product with those who received a placebo (a look-alike substance that contains no active drug) to determine product safety and any possible side effects, see if the amount of the bacterial species, Lactobacillus crispatus, changes (either increases or decreases) in response to the treatment, and to determine any impacts on self-reported odor and vaginal health.
A total of 80 participants will be recruited for this study. All participants will be supported and tracked through the various stages of the study virtually. All biomarker swabs that are taken by participants will be returned via pre-paid envelopes provided by the research team and all survey information will be collected online. No in-person visits will be required. Participants who are unwilling to follow the study protocol will be removed from the study.
- Conditions
- Vaginal Personal Care
- Being tested
- VM-02, Commercial Oral Probiotic Competitor, VM-02 Placebo
- Keywords
- Lactobacillus crispatus, vaginal odor, vaginal health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VM-02Other
VM-02 is a personal care product for vaginal health.
Commercial Oral Probiotic CompetitorDietary supplement
Commercial Oral Vaginal Probiotic Competitor is a personal care product for vaginal health.
VM-02 PlaceboOther
VM-02 Placebo is a personal care product placebo for vaginal health.
| Study group | Role | What they receive |
|---|---|---|
| Vaginal Suppository Capsule | Placebo comparator | In the VM-02 Vaginal Suppository Capsule Placebo Arm, participants will take the test vaginal suppository capsule placebo as directed. Receives: Other: VM-02 Placebo |
| Vaginal Suppository Capsule Active | Experimental | In the VM-02 Vaginal Suppository Capsule Active Arm, participants will take a test vaginal suppository capsule as directed. Receives: Other: VM-02 |
| Vaginal Suppository Tablet Active | Experimental | In the VM-02 Vaginal Suppository Tablet Active Arm, participants will take a test vaginal suppository tablet as directed. Receives: Other: VM-02 |
| Oral Capsule Active | Experimental | In the VM-02 Oral Capsule Active Arm, participants will take a test oral capsule as directed. Receives: Other: VM-02 |
| Commercial Oral Vaginal Probiotic Competitor | Other | In the Commercial Over-The-Counter (OTC) Oral Probiotic Competitor Arm, participants will take an over-the-counter competitor product as directed. Receives: Dietary Supplement: Commercial Oral Probiotic Competitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of VM-02 at 5 x 10^8 CFU/dose based on frequency and absolute number of patient reported adverse events
Measured: Throughout intervention and subsequent 4 week period following last dose
Secondary outcomes (1)
Vaginal colonization calculated by detection of each of 3 distinct Lactobacillus crispatus strains after administration of VM-02 at 5 x 10^8 CFU/dose using metagenomic sequencing and/or strain-specific PCR-based assays
Measured: 2 and 4 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start5 Dec 2022
- Primary completion15 May 2023
- Study completion15 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vaginal Personal CareStudies 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
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seed Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05659745
- Sponsor's protocol ID
- 20259
- Status last verified
- Jan 2023
- First submitted
- 1 Dec 2022
- Last updated
- 31 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ravel J, Simmons S, Jaswa EG, Gottfried S, Greene M, Kellogg-Spadt S, Gevers D, Harper DM. Impact of a multi-strain L. crispatus-based vaginal synbiotic on the vaginal microbiome: a randomized placebo-controlled trial. NPJ Biofilms Microbiomes. 2025 Aug 9;11(1):158. doi: 10.1038/s41522-025-00788-6.
PubMed 40783570
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo-controlled Trial Investigating the Role of a Personal Care Product on Vaginal Health
- ClinicalTrials.gov ID
- NCT05659745
- Acronym / sponsor ID
- 20259
- Conditions
- Vaginal Personal Care
- Keywords
- Lactobacillus crispatus, vaginal odor, vaginal health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Seed HealthIndustry (pharma, biotech, devices)
- Study start
- 5 Dec 2022 (actual)
- Primary completion
- 15 May 2023 (actual)
- Study completion
- 15 May 2023 (actual)
- First posted
- 21 Dec 2022 (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 clinical trial is to assess the impact of a personal care product on vaginal health in a healthy participant population. The personal care product, VM-02, contains a prebiotic, postbiotic, and three distinct strains of Lactobacillus crispatus, a microbe commonly found in healthy females, together accounting for greater than 85% of known genes in this species. The intervention will be compared to a placebo intervention and will aim to assess the following in a healthy female population:
Measure changes in the relative and absolute abundance of a bacterial species, Lactobacillus crispatus, in the vagina, compared the baseline (prior to use of the personal care product) to two time points after use.
Observe changes in vaginal pH and self-reported discomfort from vaginal odor, compared the baseline to two time points after use.
Determine the user experience of three variations of a personal care product administered in different formats to improve vaginal health and establish tolerability and user acceptability.
Participants will use the personal care product according to a specific program as directed, conduct vaginal swab sampling, and answer questionnaires, each at eight time points.
Detailed description
The vaginal microbiome is a dynamic microecosystem that undergoes fluctuations during the female menstrual cycle and at various life stages from puberty to menopause. A healthy vaginal microbiome is dominated by Lactobacillus which regulates vaginal pH, produces antimicrobial compounds, and significantly influences host immune response. The purpose of this study is to determine whether vaginal health can be influenced by a novel personal care product comprised of a Lactobacillus postbiotic, prebiotic, and multiple strains of Lactobacillus crispatus predictive of a stable vaginal microbiome.
This study will be a randomized double-blind, placebo-controlled intervention that will examine the safety and tolerability of a personal care product for vaginal health, VM-02. This pilot study will last for the duration of two complete menstrual cycles. Data will be collected via participant virtual questionnaires and vaginal swabs.
Participants are randomized as follows:
A two-arm randomized, double-blind, placebo-controlled study to evaluate VM-02 as a vaginal suppository capsule.
Arm #1: Vaginal application of single-use applicators filled with a vaginal suppository capsule at 5 x 10^8 CFU/dose. The study product will be administered once daily for 7 consecutive days, followed by once weekly application over 2 consecutive additional weeks.
Arm #2: Vaginal application of single-use applicators filled with a vaginal suppository placebo capsule. The study product will be administered once daily for 7 consecutive days, followed by once weekly application over 2 consecutive additional weeks.
Three additional arms are included to quantify the impact of an alternative formulation and user experience.
Arm #3: Vaginal application of single-use applicators filled with vaginal suppository tablet at 5 x 10^8 CFU/dose. The study product will be administered on Days 1,4,7,14,21.
Arm #4: Oral administration of capsule at 5 x 10^8 cfu/dose. The study product will be administered daily for 30 consecutive days.
Arm #5: Oral administration of commercially available over-the-counter oral capsule at 5 x 10^8 CFU/dose. The study product will be administered daily for 30 consecutive days.
Colonization rate of 3 distinct Lactobacillus crispatus after administration of VM-02 will be assessed with PCR and DNA sequence analysis.
Researchers will compare groups who received active product with those who received a placebo (a look-alike substance that contains no active drug) to determine product safety and any possible side effects, see if the amount of the bacterial species, Lactobacillus crispatus, changes (either increases or decreases) in response to the treatment, and to determine any impacts on self-reported odor and vaginal health.
A total of 80 participants will be recruited for this study. All participants will be supported and tracked through the various stages of the study virtually. All biomarker swabs that are taken by participants will be returned via pre-paid envelopes provided by the research team and all survey information will be collected online. No in-person visits will be required. Participants who are unwilling to follow the study protocol will be removed from the study.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Vaginal Suppository Capsule | Placebo comparator | Other: VM-02 PlaceboIn the VM-02 Vaginal Suppository Capsule Placebo Arm, participants will take the test vaginal suppository capsule placebo as directed. |
| Vaginal Suppository Capsule Active | Experimental | Other: VM-02In the VM-02 Vaginal Suppository Capsule Active Arm, participants will take a test vaginal suppository capsule as directed. |
| Vaginal Suppository Tablet Active | Experimental | Other: VM-02In the VM-02 Vaginal Suppository Tablet Active Arm, participants will take a test vaginal suppository tablet as directed. |
| Oral Capsule Active | Experimental | Other: VM-02In the VM-02 Oral Capsule Active Arm, participants will take a test oral capsule as directed. |
| Commercial Oral Vaginal Probiotic Competitor | Other | Dietary Supplement: Commercial Oral Probiotic CompetitorIn the Commercial Over-The-Counter (OTC) Oral Probiotic Competitor Arm, participants will take an over-the-counter competitor product as directed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Reproductive age women aged ≥ 18.
- History of regular menses every 21-35 days for six months prior to the study.
- Agreement not to use specified intra-vaginal products during the study product use.
- Willing to use an intra-vaginal suppository or dietary supplement during the study period.
- Willing to complete vaginal swabs on themselves as directed in the study.
Key exclusion criteria (4 listed)
- Pregnancy or planned pregnancy in the next 6 months.
- Two or more amenorrheic months in the past 6 months.
- Lives in the state of New York.
- Allergy to any components of the supporting or excipient ingredients in test formulation capsules, tablets, placebos or over-the-counter competitor product.
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 |
|---|---|---|
| VM-02VM-02 is a personal care product for vaginal health. | Other | Oral Capsule Active, Vaginal Suppository Capsule Active, Vaginal Suppository Tablet Active |
| Commercial Oral Probiotic CompetitorCommercial Oral Vaginal Probiotic Competitor is a personal care product for vaginal health. | Dietary supplement | Commercial Oral Vaginal Probiotic Competitor |
| VM-02 PlaceboVM-02 Placebo is a personal care product placebo for vaginal health. | Other | Vaginal Suppository Capsule |
Primary outcome
Safety and tolerability of VM-02 at 5 x 10^8 CFU/dose based on frequency and absolute number of patient reported adverse events
Time frame: Throughout intervention and subsequent 4 week period following last dose
1 secondary outcome
Vaginal colonization calculated by detection of each of 3 distinct Lactobacillus crispatus strains after administration of VM-02 at 5 x 10^8 CFU/dose using metagenomic sequencing and/or strain-specific PCR-based assays
Time frame: 2 and 4 weeks after intervention
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 31 May 2023.
- Derived from this study: PubMed 40783570Ravel J, Simmons S, Jaswa EG, Gottfried S, Greene M, Kellogg-Spadt S, Gevers D, Harper DM. Impact of a multi-strain L. crispatus-based vaginal synbiotic on the vaginal microbiome: a randomized placebo-controlled trial. NPJ Biofilms Microbiomes. 2025 Aug 9;11(1):158. doi: 10.1038/s41522-025-00788-6.
- Related InfoLink provided by the sponsor.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VM-02 and Commercial Oral Probiotic Competitor in people with Vaginal Personal Care, run by Seed Health at 1 site in United States.
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 6 inclusion and 4 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 31 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 United States. 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?
Safety and tolerability of VM-02 at 5 x 10^8 CFU/dose based on frequency and absolute number of patient reported adverse events (time frame: Throughout intervention and subsequent 4 week period following last dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05659745, which also lists 1 linked publication.
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 31 May 2023.