Focus is on Healthy SubjectsPhase 2VSS2NCT07246161
Vaginal Detection of Orally Delivered Probiotic Strains in Healthy Women
A Phase 2 study testing Probiotic Formula 1, Probiotic Formula 2 and Probiotic Formula 3 in people with Focus is on Healthy Subjects, run by Lallemand Health Solutions at 1 site in Canada.
Trial summary
The purpose of the present study is to obtain more information on the transit of orally ingested probiotics to the vagina. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Focus is on Healthy Subjects
- What is being tested?
- Probiotic Formula 1, Probiotic Formula 2 and Probiotic Formula 3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteCanada
- Study dates
- 20 Oct 2025to Oct 2026
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Clinically healthy female between the ages of 18 and 50 years, inclusive,
- have a regular or predictable menstrual cycle
- Typically have regular bowel movements,
- Willing and able to consume a probiotic supplement for 4 weeks,
- Willing to discontinue consumption of probiotic supplement and probiotic-fortified products 2 weeks before the start of the study and throughout the study,
- Willing to discontinue fiber supplements 2 weeks before the start of the study, and throughout the study,
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- Willing to provide 1 stool sample 4 times throughout the study,
- Willing to provide 2 vaginal swabs 4 times throughout the study,
- Willing to undergo vaginal pH swab measurements (with a swab) 5 times throughout the study,
- Willing to provide 2 perineal skin swabs (skin between the vagina and the anus) 3 times throughout the study,
- Willing to complete a pregnancy test at the screening visit.
Who cannot join
- Menopausal women,
- Vaginal pH < 2 or > 5 measured at screening,
- •. Menstruation during the sample collection times,
- Women that are lactating, pregnant, attempting to get pregnant, or have a positive pregnancy test,
- Use of vaginal probiotics in the last 3 months,
- Use of local vaginal antibiotics or antifungals in the last 3 months.
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- Use of oral antibiotics or antifungals in the last month,
- Ongoing symptoms of vaginal and/or urinary tract infections,
- Current treatment for vaginal sepsis or urosepsis,
- Currently being treated for a severe chronic disease (e.g. cancer, renal failure, chronic inflammatory digestive or gastro-intestinal disease, immunodeficiency, etc.),
- Clinical diagnosis of a gynecological disease or condition (e.g, fibroma, endometriosis, polycystic ovarian syndrome, etc.),
- Clinical diagnosis of secondary dysmenorrhea,
- Intolerance, allergy or sensitivity to milk, soy, or yeast.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Detection of Orally Delivered Probiotic Strains in the Vaginal Microbiome of Healthy Female Adults
The purpose of the present study is to obtain more information on the transit of orally ingested probiotics to the vagina.
Read the detailed description
Probiotics have emerged as novel supplements to support women's health, demonstrating benefits in maintain vaginal health and promoting recovery from dysbiosis. This includes various oral and vaginal probiotics shown to alleviate symptoms and enhance the reversal of vaginal dysbiosis.
Oral delivered probiotic strains suggest their ability to migrate and transiently colonize the vagina to support vaginal health but is not well understood. Therefore, this study will aim to provide additional information on their transit to the vagina.
- Conditions
- Focus is on Healthy Subjects
- Being tested
- Probiotic Formula 1, Probiotic Formula 2, Probiotic Formula 3
- Keywords
- Probiotics, Women's Health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic Formula 1Other
Probiotic Formula 1
Probiotic Formula 2Other
Probiotic Formula 2
Probiotic Formula 3Other
Probiotic Formula 3
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Not described Receives: Other: Probiotic Formula 1 |
| Group 2 | Experimental | Not described Receives: Other: Probiotic Formula 2 |
| Group 3 | Experimental | Not described Receives: Other: Probiotic Formula 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence or absence of probiotic stains in vaginal swabs after 28 days of oral intake
Measured: 28 days of oral intake
Secondary outcomes (7)
Presence or absence of the probiotic stains in the vaginal swabs at days 0 & 14 of oral intake, and 1 week after the end of intervention (Day 35)
Measured: From enrollment to day 35
Presence or absence of the probiotic strains in perineal skin swabs at days 0, 14, and 28 of oral intake.
Measured: From enrollment to the 28th day.
Presence or absence of the probiotic strains in stool samples at days 0, 14 and 28 of oral intake.
Measured: From enrollment to 28th day
Viability of the probiotic strains recovered from vaginal swabs at days 0, 14, and 28 of oral intake, and 1 week after the end of the intervention (Day 35)
Measured: From enrollment to the 35th day.
Viability of the probiotic strains recovered from perineal skin swabs at day 0, 14, and 28 of oral intake.
Measured: From enrollment to 28th day
Changes in vaginal pH from baseline to 1 week after the end of the intervention (Day 35)
Measured: From baseline to day 35.
Changes in the abundance of endogenous and pathogenic bacterial and fungal species in the vagina at days 0, 14, 28 and 35.
Measured: From enrollment to the 35th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start20 Oct 2025
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focus is on Healthy SubjectsStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lallemand Health Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07246161
- Sponsor's protocol ID
- L-032
- Other IDs
- 25AQ-1030
- Acronym
- VSS2
- Status last verified
- Jun 2026
- First submitted
- 13 Nov 2025
- Last updated
- 18 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Orally Delivered Probiotic Strains in the Vaginal Microbiome of Healthy Female Adults
- ClinicalTrials.gov ID
- NCT07246161
- Acronym / sponsor ID
- VSS2 / L-032
- Conditions
- Focus is on Healthy Subjects
- Keywords
- Probiotics, Women's Health
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Lallemand Health SolutionsIndustry (pharma, biotech, devices)
- Study start
- 20 Oct 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 24 Nov 2025 (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 purpose of the present study is to obtain more information on the transit of orally ingested probiotics to the vagina.
Detailed description
Probiotics have emerged as novel supplements to support women's health, demonstrating benefits in maintain vaginal health and promoting recovery from dysbiosis. This includes various oral and vaginal probiotics shown to alleviate symptoms and enhance the reversal of vaginal dysbiosis.
Oral delivered probiotic strains suggest their ability to migrate and transiently colonize the vagina to support vaginal health but is not well understood. Therefore, this study will aim to provide additional information on their transit to the vagina.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: Probiotic Formula 1 |
| Group 2 | Experimental | Other: Probiotic Formula 2 |
| Group 3 | Experimental | Other: Probiotic Formula 3 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Clinically healthy female between the ages of 18 and 50 years, inclusive,
- have a regular or predictable menstrual cycle
- Typically have regular bowel movements,
- Willing and able to consume a probiotic supplement for 4 weeks,
- Willing to discontinue consumption of probiotic supplement and probiotic-fortified products 2 weeks before the start of the study and throughout the study,
Key exclusion criteria (13 listed)
- Menopausal women,
- Vaginal pH < 2 or > 5 measured at screening,
- •. Menstruation during the sample collection times,
- Women that are lactating, pregnant, attempting to get pregnant, or have a positive pregnancy test,
- Use of vaginal probiotics in the last 3 months,
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 |
|---|---|---|
| Probiotic Formula 1Probiotic Formula 1 | Other | Group 1 |
| Probiotic Formula 2Probiotic Formula 2 | Other | Group 2 |
| Probiotic Formula 3Probiotic Formula 3 | Other | Group 3 |
Primary outcome
Presence or absence of probiotic stains in vaginal swabs after 28 days of oral intake
Time frame: 28 days of oral intake
7 secondary outcomes
Presence or absence of the probiotic stains in the vaginal swabs at days 0 & 14 of oral intake, and 1 week after the end of intervention (Day 35)
Time frame: From enrollment to day 35
Presence or absence of the probiotic strains in perineal skin swabs at days 0, 14, and 28 of oral intake.
Time frame: From enrollment to the 28th day.
Presence or absence of the probiotic strains in stool samples at days 0, 14 and 28 of oral intake.
Time frame: From enrollment to 28th day
Viability of the probiotic strains recovered from vaginal swabs at days 0, 14, and 28 of oral intake, and 1 week after the end of the intervention (Day 35)
Time frame: From enrollment to the 35th day.
Viability of the probiotic strains recovered from perineal skin swabs at day 0, 14, and 28 of oral intake.
Time frame: From enrollment to 28th day
Changes in vaginal pH from baseline to 1 week after the end of the intervention (Day 35)
Time frame: From baseline to day 35.
Changes in the abundance of endogenous and pathogenic bacterial and fungal species in the vagina at days 0, 14, 28 and 35.
Time frame: From enrollment to the 35th day
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 18 Jun 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Probiotic Formula 1, Probiotic Formula 2 and Probiotic Formula 3 in people with Focus is on Healthy Subjects, run by Lallemand Health Solutions at 1 site in Canada.
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 11 inclusion and 13 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 18 Jun 2026. 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 Canada. 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?
Contact Jenna Bouassaly, MSc (514-223-2057, jbouassaly@lallemand.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence or absence of probiotic stains in vaginal swabs after 28 days of oral intake (time frame: 28 days of oral intake). 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 18 Jun 2026.