Vaginal HealthNCT05330091
Garden of Life Once Daily Women's Probiotic: Vaginal pH and Quality of Life Study
An observational study of Vaginal Health, run by Garden of Life, LLC at 1 site in United States.
Trial summary
This decentralized observational study is designed to understand the effects of daily consumption of once daily woman's probiotic (ODWP) on vaginal pH levels in healthy female populations ages 19-70 years of age across the United States. Read more about this study
- Who is it for?
- Ages 19 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaginal Health
- What is being tested?
- Once Daily Women's Probiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Feb 2022to 31 Oct 2022
- Phase
- Observational
- 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 19 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: The population for this study will be generally healthy adults (19-70 years old) willing to consume ODWP or placebo of whom half have a history of bacterial vaginosis, and half who do not have such a history. Between 20-30% of the total population will be post- menopausal and will be distributed relatively equally between the 4 groups in the study.
Who may be able to join
- Age: 19-70 (21-70 for residents of Mississippi)
- Non-menopausal women must have a regular menstrual cycle (26-32 days)
- Using birth control
- Sexually active (intercourse at least 2x/month)
- Agree to not introduce any other probiotic during the three months of study
Who cannot join
- OCP or systemic hormonal contraception
- No antibiotic treatment for at least 30 days
- No active vaginal infection or symptoms of infection
- No probiotic use for 30 days
- Routine douching (except for immediately after menses)
Trial locations and contacts
1 site in 1 country.
United States1 site
Syzygy Research Solutions
Wellington, Florida, 33414
About this study
This decentralized observational study is designed to understand the effects of daily consumption of once daily woman's probiotic (ODWP) on vaginal pH levels in healthy female populations ages 19-70 years of age across the United States.
Read the detailed description
This decentralized observational study is designed to understand the effects of daily consumption of once daily woman's probiotic (ODWP) on vaginal pH levels in healthy female populations ages 19-70 years of age across the United States. Participants will be divided into two cohorts of 100 participants each; one with a history of vaginal bacteriosis and one with no history of bacterial vaginosis, with between 20-30 percent of the total participants being post-menopausal. Participants will be provided and trained to use pH tests on a daily basis over the course of four menstrual cycles (or equivalent time for amenorrheic participants). During the first cycle (or equivalent timeframe) of measurement, participants will not consume neither placebo or once daily woman's probiotics (ODWP); allowing the establishment of a baseline or wash out period prior to active consumption and measurement of effect.
Participants will receive ODWP at no charge for consumption over the course of the study. Participants will be instructed to start and continue consumption over three menstrual cycles (or equivalent timeframe) based on participant's menstrual status and her demonstrated ability to self-measure and report vaginal pH via the Validcare Study app based platform (aka "the app), which is provided as a free, downloadable 21 CFR Part 11 compliant interface for all patient facing activities and communication with/from the principal investigator for the study duration.
- Conditions
- Vaginal Health
- Being tested
- Once Daily Women's Probiotic, Placebo
- Keywords
- Probiotics, Bacterial Vaginosis, Vaginal pH
- Medical subject headings
- Vaginosis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Once Daily Women's ProbioticDietary supplement
Active product
PlaceboOther
Placebo product
| Study group | Role | What they receive |
|---|---|---|
| Healthy Women | Once Daily Women's Probiotic Placebo Receives: Dietary Supplement: Once Daily Women's Probiotic; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaginal pH
To compare the change in vaginal pH in both normal women and in normal women with a history of BV to and after treatment with Once Daily Women's Probiotic vs. placebo. Subjects will measure vaginal pH using a self-administered vaginal pH kit.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start9 Feb 2022
- Primary completion30 Sep 2022 (estimated)
- Study completion31 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal HealthStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Garden of Life, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Validcare, LLC
- Responsible party
- Sponsor
- Investigators
- Robert Kaufmann, MD, Study director, Validcare, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05330091
- Sponsor's protocol ID
- VCODWP1
- Status last verified
- Aug 2022
- First submitted
- 25 Mar 2022
- Last updated
- 3 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will not be shared with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Garden of Life Once Daily Women's Probiotic: Vaginal pH and Quality of Life Study
- ClinicalTrials.gov ID
- NCT05330091
- Acronym / sponsor ID
- VCODWP1
- Conditions
- Vaginal Health
- Keywords
- Probiotics, Bacterial Vaginosis, Vaginal pH
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Garden of Life, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Validcare, LLC
- Study start
- 9 Feb 2022 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 31 Oct 2022 (estimated)
- First posted
- 15 Apr 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.
This decentralized observational study is designed to understand the effects of daily consumption of once daily woman's probiotic (ODWP) on vaginal pH levels in healthy female populations ages 19-70 years of age across the United States.
Detailed description
This decentralized observational study is designed to understand the effects of daily consumption of once daily woman's probiotic (ODWP) on vaginal pH levels in healthy female populations ages 19-70 years of age across the United States. Participants will be divided into two cohorts of 100 participants each; one with a history of vaginal bacteriosis and one with no history of bacterial vaginosis, with between 20-30 percent of the total participants being post-menopausal. Participants will be provided and trained to use pH tests on a daily basis over the course of four menstrual cycles (or equivalent time for amenorrheic participants). During the first cycle (or equivalent timeframe) of measurement, participants will not consume neither placebo or once daily woman's probiotics (ODWP); allowing the establishment of a baseline or wash out period prior to active consumption and measurement of effect.
Participants will receive ODWP at no charge for consumption over the course of the study. Participants will be instructed to start and continue consumption over three menstrual cycles (or equivalent timeframe) based on participant's menstrual status and her demonstrated ability to self-measure and report vaginal pH via the Validcare Study app based platform (aka "the app), which is provided as a free, downloadable 21 CFR Part 11 compliant interface for all patient facing activities and communication with/from the principal investigator for the study duration.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Women | – | Dietary Supplement: Once Daily Women's Probiotic, Other: PlaceboOnce Daily Women's Probiotic Placebo |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The population for this study will be generally healthy adults (19-70 years old) willing to consume ODWP or placebo of whom half have a history of bacterial vaginosis, and half who do not have such a history. Between 20-30% of the total population will be post- menopausal and will be distributed relatively equally between the 4 groups in the study.
Key inclusion criteria (5 listed)
- Age: 19-70 (21-70 for residents of Mississippi)
- Non-menopausal women must have a regular menstrual cycle (26-32 days)
- Using birth control
- Sexually active (intercourse at least 2x/month)
- Agree to not introduce any other probiotic during the three months of study
Key exclusion criteria (5 listed)
- OCP or systemic hormonal contraception
- No antibiotic treatment for at least 30 days
- No active vaginal infection or symptoms of infection
- No probiotic use for 30 days
- Routine douching (except for immediately after menses)
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 |
|---|---|---|
| Once Daily Women's ProbioticActive product | Dietary supplement | Healthy Women |
| PlaceboPlacebo product | Other | Healthy Women |
Primary outcome
Vaginal pH
Time frame: 4 months
To compare the change in vaginal pH in both normal women and in normal women with a history of BV to and after treatment with Once Daily Women's Probiotic vs. placebo. Subjects will measure vaginal pH using a self-administered vaginal pH kit.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2022.
- Individual participant dataSharing planned: No. Data will not be shared with other researchers
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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.
Robert Kaufmann, MD study director
Validcare, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vaginal Health, run by Garden of Life, LLC 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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 3 Aug 2022. 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. 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?
Results are not available in the source record.
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 pH (time frame: 4 months). 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 Aug 2022.