Clinical trial NCT05330091: Garden of Life Once Daily Women's Probiotic: Vaginal pH and Quality of Life Study
Official title: Garden of Life Once Daily Women's Probiotic: Vaginal pH and Quality of Life Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Vaginal Health
Keywords: Probiotics
Bacterial Vaginosis
Vaginal pH
Lead sponsor: Garden of Life, LLC
Sponsor class: INDUSTRY
Collaborators: name: Validcare, LLC
First posted: 2022-04-15
Enrollment: 200
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Vaginal pH
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Wellington
country: United States
facility: Syzygy Research Solutions
state: Florida
Study officials:
affiliation: Validcare, LLC
name: Robert Kaufmann, MD
role: STUDY_DIRECTOR
References: