Bacterial VaginosisNCT06665126
A Study to Evaluate the Effects of a Prebiotic and Probiotic Supplement to Provide Relief From Symptoms Associated With Bacterial Vaginosis and Yeast Infections.
A study testing Prebiotic + Probiotic Supplement in people with Bacterial Vaginosis and Yeast Infection, run by Happy V at 1 site in United States.
Trial summary
This virtual randomized controlled trial evaluates the efficacy of a prebiotic and probiotic supplement in providing relief from symptoms associated with bacterial vaginosis and yeast infections. Read more about this study
- Who is it for?
- Ages 25 years and older, women only
- Conditions the study is for
- Bacterial Vaginosis, Yeast Infection
- What is being tested?
- Prebiotic + Probiotic Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Oct 2024to 3 Mar 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 25 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women
- Age 25+
- Self-reported concerns symptoms associated with bacterial vaginosis or candida overgrowth, including itchiness, redness, abnormal discharge, and an unpleasant odor.
- Suffers from digestive issues, including bloating, gas, or other digestive discomfort.
- Generally healthy - do not live with any uncontrolled chronic diseases.
- Willing to avoid using any vaginal health-related medications, supplements, and herbal remedies for the duration of this study.
- If taking oral supplements or herbal remedies targeted at vaginal health, has been consistently taking these for at least 3 months prior to starting the study and is willing to maintain this routine for the study duration.
Who cannot join
- Any pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders
- Planning to undergo any procedure related to their vaginal health.
- Started any new medications or supplements that target vaginal health in the past 3 months.
- Anyone with known severe allergic reactions that require the use of an Epi-Pen, or any known allergies to any of the product ingredients
- Women who are pregnant, breastfeeding, or attempting to conceive
- Unwilling to follow the study protocol
- Anyone who has undergone any surgeries or invasive treatments in the last three months or has any planned during the study period.
Trial locations and contacts
1 site in 1 country.
About this study
This virtual randomized controlled trial evaluates the efficacy of a prebiotic and probiotic supplement in providing relief from symptoms associated with bacterial vaginosis and yeast infections. Participants will be randomized into three groups-test product, active placebo, and excipient placebo-and will take two capsules daily for 30 days. The study will assess the effects on vaginal microbiome, symptoms of bacterial vaginosis and yeast infections, and overall vaginal health.
- Conditions
- Bacterial Vaginosis, Yeast Infection
- Being tested
- Prebiotic + Probiotic Supplement, Active Placebo Supplement, Excipient Placebo Supplement
- Medical subject headings
- Vaginosis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prebiotic + Probiotic SupplementDietary supplement
This intervention includes a combination of prebiotics and probiotics designed to promote vaginal and digestive health. The supplement contains Biotin, Lactobacillus acidophilus (as LA-14®), Bifidobacterium lactis (HN019™), Lactobacillus rhamnosus (as HN001™), Lactobacillus crispatus (as CCFM1110™), Lactobacillus gasseri (as HLG13™), Lactobacillus reuteri (as HR7™), Bacillus subtilis (as DE111®), PreforPro®, White Rice Flour, Magnesium Stearate (Vegetable Source), Silicon Dioxide (Bamboo Source), and Cellulose (Vegetable Capsule). Participants take two capsules daily with food for 30 days.
Active Placebo SupplementDietary supplement
The active placebo supplement contains similar probiotic strains without the prebiotic component. Ingredients include Biotin, Lactobacillus acidophilus, Bifidobacterium lactis, Lactobacillus rhamnosus, Lactobacillus crispatus, Lactobacillus gasseri, Lactobacillus reuteri, Bacillus subtilis, Inulin (from Chicory Root), White Rice Flour, Magnesium Stearate (Vegetable Source), Silicon Dioxide (Bamboo Source), and Cellulose (Vegetable Capsule). Participants take two capsules daily with food for 30 days.
Excipient Placebo SupplementDietary supplement
The excipient placebo supplement contains no active ingredients related to prebiotics or probiotics. It includes White Rice Flour, Magnesium Stearate (Vegetable Source), and Cellulose (Vegetable Capsule). Participants take two capsules daily with food for 30 days.
| Study group | Role | What they receive |
|---|---|---|
| Test Product Group | Experimental | Participants in this group will receive the test product, a prebiotic and probiotic supplement. Receives: Dietary Supplement: Prebiotic + Probiotic Supplement |
| Active Placebo Group | Placebo comparator | Participants in this group will receive an active placebo. Receives: Dietary Supplement: Active Placebo Supplement |
| Excipient Placebo Group | Placebo comparator | Participants in this group will receive an excipient placebo. Receives: Dietary Supplement: Excipient Placebo Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Vaginal Microbiome
This outcome measures the change in vaginal microbiome parameters from Baseline to Day 30. The vaginal microbiome will be assessed using microbiome sequencing at both Baseline and Day 30.
Measured: Baseline, Day 30
Secondary outcomes (2)
Change in Perceived Symptoms of Bacterial Vaginosis
This outcome measures the change in symptoms associated with bacterial vaginosis and yeast infections (e.g., itchiness, odor, abnormal discharge) as reported by participants through questionnaires.
Measured: Baseline, Day 1, Day 7, Day 14, Day 21, Day 30
Change in Perceived Symptoms of Yeast Infections
This outcome measures the change in symptoms associated with bacterial vaginosis and yeast infections (e.g., itchiness, odor, abnormal discharge) as reported by participants through questionnaires.
Measured: Baseline, Day 1, Day 7, Day 14, Day 21, Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2024
- Study start4 Oct 2024
- Primary completion3 Mar 2025
- Study completion3 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial VaginosisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized into 3 groups (test product, active placebo, excipient placebo).
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Happy V
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06665126
- Sponsor's protocol ID
- 20397
- Status last verified
- Aug 2026
- First submitted
- 7 Oct 2024
- Last updated
- 13 Aug 2026
- 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 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Effects of a Prebiotic and Probiotic Supplement to Provide Relief From Symptoms Associated With Bacterial Vaginosis and Yeast Infections.
- ClinicalTrials.gov ID
- NCT06665126
- Acronym / sponsor ID
- 20397
- Conditions
- Bacterial Vaginosis, Yeast Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Happy VIndustry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Study start
- 4 Oct 2024 (actual)
- Primary completion
- 3 Mar 2025 (actual)
- Study completion
- 3 Mar 2025 (actual)
- First posted
- 30 Oct 2024 (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 virtual randomized controlled trial evaluates the efficacy of a prebiotic and probiotic supplement in providing relief from symptoms associated with bacterial vaginosis and yeast infections. Participants will be randomized into three groups-test product, active placebo, and excipient placebo-and will take two capsules daily for 30 days. The study will assess the effects on vaginal microbiome, symptoms of bacterial vaginosis and yeast infections, and overall vaginal health.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Participants will be randomized into 3 groups (test product, active placebo, excipient placebo).
| Arm | Type | Receives |
|---|---|---|
| Test Product Group | Experimental | Dietary Supplement: Prebiotic + Probiotic SupplementParticipants in this group will receive the test product, a prebiotic and probiotic supplement. |
| Active Placebo Group | Placebo comparator | Dietary Supplement: Active Placebo SupplementParticipants in this group will receive an active placebo. |
| Excipient Placebo Group | Placebo comparator | Dietary Supplement: Excipient Placebo SupplementParticipants in this group will receive an excipient placebo. |
Who may qualify
- Ages
- 25 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Women
- Age 25+
- Self-reported concerns symptoms associated with bacterial vaginosis or candida overgrowth, including itchiness, redness, abnormal discharge, and an unpleasant odor.
- Suffers from digestive issues, including bloating, gas, or other digestive discomfort.
- Generally healthy - do not live with any uncontrolled chronic diseases.
Key exclusion criteria (7 listed)
- Any pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders
- Planning to undergo any procedure related to their vaginal health.
- Started any new medications or supplements that target vaginal health in the past 3 months.
- Anyone with known severe allergic reactions that require the use of an Epi-Pen, or any known allergies to any of the product ingredients
- Women who are pregnant, breastfeeding, or attempting to conceive
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 |
|---|---|---|
| Prebiotic + Probiotic SupplementThis intervention includes a combination of prebiotics and probiotics designed to promote vaginal and digestive health. The supplement contains Biotin, Lactobacillus acidophilus (as LA-14®), Bifidobacterium lactis (HN019™), Lactobacillus rhamnosus (as HN001™), Lactobacillus crispatus (as CCFM1110™), Lactobacillus gasseri (as HLG13™), Lactobacillus reuteri (as HR7™), Bacillus subtilis (as DE111®), PreforPro®, White Rice Flour, Magnesium Stearate (Vegetable Source), Silicon Dioxide (Bamboo Source), and Cellulose (Vegetable Capsule). Participants take two capsules daily with food for 30 days. | Dietary supplement | Test Product Group |
| Active Placebo SupplementThe active placebo supplement contains similar probiotic strains without the prebiotic component. Ingredients include Biotin, Lactobacillus acidophilus, Bifidobacterium lactis, Lactobacillus rhamnosus, Lactobacillus crispatus, Lactobacillus gasseri, Lactobacillus reuteri, Bacillus subtilis, Inulin (from Chicory Root), White Rice Flour, Magnesium Stearate (Vegetable Source), Silicon Dioxide (Bamboo Source), and Cellulose (Vegetable Capsule). Participants take two capsules daily with food for 30 days. | Dietary supplement | Active Placebo Group |
| Excipient Placebo SupplementThe excipient placebo supplement contains no active ingredients related to prebiotics or probiotics. It includes White Rice Flour, Magnesium Stearate (Vegetable Source), and Cellulose (Vegetable Capsule). Participants take two capsules daily with food for 30 days. | Dietary supplement | Excipient Placebo Group |
Primary outcome
Change in Vaginal Microbiome
Time frame: Baseline, Day 30
This outcome measures the change in vaginal microbiome parameters from Baseline to Day 30. The vaginal microbiome will be assessed using microbiome sequencing at both Baseline and Day 30.
2 secondary outcomes
Change in Perceived Symptoms of Bacterial Vaginosis
Time frame: Baseline, Day 1, Day 7, Day 14, Day 21, Day 30
Change in Perceived Symptoms of Yeast Infections
Time frame: Baseline, Day 1, Day 7, Day 14, Day 21, Day 30
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 13 Aug 2026.
- Individual participant dataSharing planned: No
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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. 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 Prebiotic + Probiotic Supplement in people with Bacterial Vaginosis and Yeast Infection, run by Happy V 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 7 inclusion and 7 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 13 Aug 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 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?
Change in Vaginal Microbiome (time frame: Baseline, Day 30). 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 13 Aug 2026.