Vaginal Health
Conditions
Keywords
Probiotics, Bacterial Vaginosis, Vaginal pH
Brief 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.
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.
Interventions
DIETARY_SUPPLEMENTOnce Daily Women's Probiotic
Active product
OTHERPlacebo
Placebo product
Sponsors
Validcare, LLC
Garden of Life, LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
19 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
1. Age: 19-70 (21-70 for residents of Mississippi) 2. Non-menopausal women must have a regular menstrual cycle (26-32 days) 3. Using birth control 4. Sexually active (intercourse at least 2x/month) 5. Agree to not introduce any other probiotic during the three months of study
Exclusion criteria
1. OCP or systemic hormonal contraception 2. No antibiotic treatment for at least 30 days 3. No active vaginal infection or symptoms of infection 4. No probiotic use for 30 days 5. Routine douching (except for immediately after menses)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vaginal pH | 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. |
Countries
United States
Outcome results
None listed