Vaginal OdorNCT07829861
The Effects of an Orally-Administered Probiotic on Vaginal Symptoms
A study testing Orally-administered probiotic in people with Vaginal Odor, run by Bonafide Health at 1 site in United States.
Trial summary
This randomized, double-blind, placebo-controlled, virtual trial is designed to determine the efficacy of an orally-administered probiotic on alleviating vaginal odor and other vaginal symptoms. Eligibility is determined by the presence of vaginal symptoms. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Vaginal Odor
- What is being tested?
- Orally-administered probiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jul 2025to 22 Jan 2026
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Healthy women who are 18-65 years of age (inclusive).
- Have a body mass index (BMI) between 18.5 to 29.9 kg/m2 (inclusive).
- Experiences vaginal odor.
- Maintains study eligibility status during the run-in period (as outlined during the pre-screening period) from screening through the end of the study.
- Have no current medical diagnosis of active bacterial vaginosis (BV), vulvovaginal candidiasis (VVC), or urinary tract infection (UTI), or any other active infectious, inflammatory, or neoplastic vulvovaginal or genitourinary disorder.
- Have not been medically diagnosed with recurrent BV as defined by 3 or more diagnosed infections in the past 12 months, recurrent VVC as defined by 3 or more symptomatic, diagnosed infections in the past 12 months, or recurrent UTIs as defined by 3 or more diagnosed infections in the past year or 2 or more diagnosed infections in the past 6 months.
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- In good general health (no active or uncontrolled diseases or conditions) and able to consume the study product.
- Willing to report information related to your menstrual cycle and menopause status.
- Agree to refrain from using probiotic/prebiotic supplements (oral or vaginal); boric acid; pH-balancing tampons, pads, wipes, and washes; antifungals (oral or vaginal); antibiotics, and other treatments listed in Section 6.5 during the defined timeframe.
- Agree to refrain from making changes to current level of consumption of foods containing probiotics/prebiotics.
- Willing and able to agree to the requirements and restrictions of this study, be willing to give voluntary consent, be able to understand and read the questionnaires, and carry out all study-related procedures.
Who cannot join
- Active infectious, inflammatory, or neoplastic vulvovaginal or genitourinary disorder (such as vulvovaginal candidiasis, bacterial vaginosis, urinary tract infection, vulvar intraepithelial neoplasia, or lichen sclerosis).
- Symptomatic sexually transmitted infection.
- Use of probiotics within the past 3 months.
- Any prior use of intervention product.
- Use of antibiotics within the past 3 months.
- Vaginal hormone therapy (unless dosage and modality has been stable for 90 days prior to enrollment).
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- Current use of any medications, supplements, or over-the-counter remedies (including boric acid and deodorants) for vaginal odor.
- Vaginal rinses, moisturizers, cooling devices, cooling mattresses, or cooling sprays (unless habitually used for at least 90 days prior to enrollment).
- Self-reported urinary incontinence.
- Currently lactating, pregnant, or planning to become pregnant during the study period.
- Known sensitivity, intolerability, or allergy to any of the study products or their ingredients.
- Any clinically significant disease or disorder which, in the opinion of the study investigator, may place you at undue risk or harm, interfere with ability to participate, compromise the interpretability of the study data.
- History of alcohol or substance abuse in the last 5 years.
- History of smoking in the last 2 years.
- Currently participating in another clinical research study on vulvovaginal health.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Trial of An Orally-Administered Vaginal Probiotic for Validation of Patient-Reported Vaginal Odor Outcomes
This randomized, double-blind, placebo-controlled, virtual trial is designed to determine the efficacy of an orally-administered probiotic on alleviating vaginal odor and other vaginal symptoms. Eligibility is determined by the presence of vaginal symptoms. Participation in the trial lasts approximately 75 days; during 15 of these days, participants consume a capsule containing the active form of the probiotic or a placebo. Participants complete weekly questionnaires with items pertaining to their subjective vaginal health as well as a daily diary during participation.
Read the detailed description
This randomized, double-blind, placebo-controlled, virtual trial is designed to determine the efficacy of an orally-administered probiotic on alleviating vaginal odor and other vaginal symptoms on women who experience vaginal odor and are otherwise healthy. Eligibility is determined by the presence of vaginal symptoms. Participation in the trial lasts approximately 75 days. Preceding intervention, there is a 7-day run-in period. Participants who surpass the run-in period take a dose of the orally-administered study product (active or placebo) once daily for 15 days, which is followed by a 15-day off-treatment period. Participants complete weekly questionnaires and daily diaries with items pertaining to their subjective vaginal health during the run-in and intervention periods. Participants then enter into a 30-day washout period, ending with the completion of one final questionnaire.
- Conditions
- Vaginal Odor
- Being tested
- Orally-administered probiotic, Placebo
- Keywords
- vaginal health, vaginal odor, vaginal discharge, vaginal irritation, vaginal itching, vaginal microbiome
- Medical subject headings
- Vaginal Discharge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orally-administered probioticDietary supplement
Capsule containing active form of dietary supplement
PlaceboDietary supplement
Capsule containing placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Capsule containing placebo Receives: Dietary Supplement: Placebo |
| Active | Active comparator | Capsule containing active probiotic supplement Receives: Dietary Supplement: Orally-administered probiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaginal odor frequency
Change in self-reported vaginal odor frequency across weekly timepoints and between groups during the intervention period as measured by the internally-developed 8-point Vaginal Odor Frequency Scale, where 0= 0 days (Never) and 7= 7 days (Every day).
Measured: From Baseline to the end of Intervention Period at Week 4
Vaginal odor severity
Change in self-reported vaginal odor severity across weekly timepoints and between groups during the intervention period as measured by the internally-developed 6-point Vaginal Odor Severity Scale, where 0= Absent and 5= Very Severe.
Measured: From Baseline to the end of Intervention Period at Week 4
Secondary outcomes (4)
Vaginal odor bothersomeness
Change in self-reported vaginal odor bothersomeness across weekly timepoints and between groups during the intervention period as measured by the internally-developed 6-point Vaginal Odor Bothersomeness Scale, where 0= Not Bothersome At All and 5= Extremely Bothersome.
Measured: From Baseline to the end of Intervention Period at Week 4
Vaginal symptoms as measured by the vulvovaginal symptoms questionnaire (VSQ)
Change in self-reported vaginal health symptoms across weekly timepoints and between groups during the intervention period as measured by the clinically-validated vulvovaginal symptoms questionnaire (VSQ). The VSQ includes 21 binary (i.e., Yes/No) questions pertaining to vaginal health and its impact on daily life.
Measured: From Baseline to Week 4 of the Intervention Period
Vaginal Odor Buden Index (OBI)
Vaginal Odor Buden Index (OBI) is the calculated product of weekly Vaginal Odor Severity and Vaginal Odor Frequency scores during the intervention period. Vaginal OBI score can range from 0-35 (as a product of the 0-5 Vaginal Odor Severity scale and 0-7 Vaginal Odor Frequency scale), with 0 classified as 'None,' 1-8 classified as 'Mild,' 9-20 classified as 'Moderate,' and 21-35 classified as 'Severe.'
Measured: From Baseline to the end of Intervention Period at Week 4
Good vs Bad Vaginal Odor Days
The proportion of "good" odor days, which is defined as the change in self-reported ratio of "good", "neither bad nor good", and "bad" vaginal odor days across daily timepoints and between groups during the intervention period. Participants select whether they categorize the past 24 hours as a "good", "neither bad nor good", or "bad" vaginal odor day each day.
Measured: Daily from Baseline to Week 4 during the Intervention Period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start29 Jul 2025
- Primary completion22 Jan 2026
- Study completion22 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal OdorStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bonafide Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07829861
- Sponsor's protocol ID
- BH-CLV-BT-001
- Other IDs
- 14112
- Status last verified
- Sep 2026
- First submitted
- 15 Sep 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Single site
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Trial of An Orally-Administered Vaginal Probiotic for Validation of Patient-Reported Vaginal Odor Outcomes
- ClinicalTrials.gov ID
- NCT07829861
- Acronym / sponsor ID
- BH-CLV-BT-001
- Conditions
- Vaginal Odor
- Keywords
- vaginal health, vaginal odor, vaginal discharge, vaginal irritation, vaginal itching, vaginal microbiome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Bonafide HealthIndustry (pharma, biotech, devices)
- Study start
- 29 Jul 2025 (actual)
- Primary completion
- 22 Jan 2026 (actual)
- Study completion
- 22 Jan 2026 (actual)
- First posted
- 21 Sep 2026 (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 randomized, double-blind, placebo-controlled, virtual trial is designed to determine the efficacy of an orally-administered probiotic on alleviating vaginal odor and other vaginal symptoms. Eligibility is determined by the presence of vaginal symptoms. Participation in the trial lasts approximately 75 days; during 15 of these days, participants consume a capsule containing the active form of the probiotic or a placebo. Participants complete weekly questionnaires with items pertaining to their subjective vaginal health as well as a daily diary during participation.
Detailed description
This randomized, double-blind, placebo-controlled, virtual trial is designed to determine the efficacy of an orally-administered probiotic on alleviating vaginal odor and other vaginal symptoms on women who experience vaginal odor and are otherwise healthy. Eligibility is determined by the presence of vaginal symptoms. Participation in the trial lasts approximately 75 days. Preceding intervention, there is a 7-day run-in period. Participants who surpass the run-in period take a dose of the orally-administered study product (active or placebo) once daily for 15 days, which is followed by a 15-day off-treatment period. Participants complete weekly questionnaires and daily diaries with items pertaining to their subjective vaginal health during the run-in and intervention periods. Participants then enter into a 30-day washout period, ending with the completion of one final questionnaire.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboCapsule containing placebo |
| Active | Active comparator | Dietary Supplement: Orally-administered probioticCapsule containing active probiotic supplement |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Healthy women who are 18-65 years of age (inclusive).
- Have a body mass index (BMI) between 18.5 to 29.9 kg/m2 (inclusive).
- Experiences vaginal odor.
- Maintains study eligibility status during the run-in period (as outlined during the pre-screening period) from screening through the end of the study.
- Have no current medical diagnosis of active bacterial vaginosis (BV), vulvovaginal candidiasis (VVC), or urinary tract infection (UTI), or any other active infectious, inflammatory, or neoplastic vulvovaginal or genitourinary disorder.
Key exclusion criteria (15 listed)
- Active infectious, inflammatory, or neoplastic vulvovaginal or genitourinary disorder (such as vulvovaginal candidiasis, bacterial vaginosis, urinary tract infection, vulvar intraepithelial neoplasia, or lichen sclerosis).
- Symptomatic sexually transmitted infection.
- Use of probiotics within the past 3 months.
- Any prior use of intervention product.
- Use of antibiotics within the past 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 |
|---|---|---|
| Orally-administered probioticCapsule containing active form of dietary supplement | Dietary supplement | Active |
| PlaceboCapsule containing placebo | Dietary supplement | Placebo |
Primary outcome
Vaginal odor frequency
Time frame: From Baseline to the end of Intervention Period at Week 4
Change in self-reported vaginal odor frequency across weekly timepoints and between groups during the intervention period as measured by the internally-developed 8-point Vaginal Odor Frequency Scale, where 0= 0 days (Never) and 7= 7 days (Every day).
Vaginal odor severity
Time frame: From Baseline to the end of Intervention Period at Week 4
Change in self-reported vaginal odor severity across weekly timepoints and between groups during the intervention period as measured by the internally-developed 6-point Vaginal Odor Severity Scale, where 0= Absent and 5= Very Severe.
4 secondary outcomes
Vaginal odor bothersomeness
Time frame: From Baseline to the end of Intervention Period at Week 4
Vaginal symptoms as measured by the vulvovaginal symptoms questionnaire (VSQ)
Time frame: From Baseline to Week 4 of the Intervention Period
Vaginal Odor Buden Index (OBI)
Time frame: From Baseline to the end of Intervention Period at Week 4
Good vs Bad Vaginal Odor Days
Time frame: Daily from Baseline to Week 4 during the Intervention Period
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 21 Sep 2026.
- Individual participant dataSharing planned: No. Single site
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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 Orally-administered probiotic in people with Vaginal Odor, run by Bonafide 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 11 inclusion and 15 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 21 Sep 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?
Vaginal odor frequency (time frame: From Baseline to the end of Intervention Period at Week 4). The study lists 2 primary outcomes in all. 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 21 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.