NCT05330091

Garden of Life Once Daily Women's Probiotic: Vaginal pH and Quality of Life Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Garden of Life, LLC · Industry
• Sex: Female
• Age: 19 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Vaginal Health

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Once Daily Women's Probiotic	Active product
OTHER	Placebo	Placebo product

Timeline

• Start date: 2022-02-09
• Primary completion: 2022-09-30
• Completion: 2022-10-31
• First posted: 2022-04-15
• Last updated: 2022-08-03

Locations

1 site across 1 country: United States