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

• Conditions: Vaginal Health
• Interventions: Dietary Supplement: Once Daily Women's Probiotic; Other: Placebo

• Registration Number: NCT05330091
• Lead Sponsor: Garden of Life, LLC

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.

Study Timeline

• Study Start: 2022-02-09
• Study First Submitted: 2022-03-25
• Study First Submitted QC: 2022-04-08
• Study First Posted: 2022-04-15
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-01
• Last Update Posted: 2022-08-03
• Primary Completion: 2022-09-30
• Study Completion: 2022-10-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 200

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy Women	Once Daily Women's Probiotic	Once Daily Women's Probiotic Placebo
Healthy Women	Placebo	Once Daily Women's Probiotic Placebo

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Syzygy Research Solutions; 🇺🇸 Wellington, Florida, United States