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

Study Overview

• Status: Active, not recruiting
• Conditions: Vaginal Health
• Intervention / Treatment: Dietary supplement: Once Daily Women's Probiotic; Other: Placebo

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 Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• United States
  • Florida
    • Wellington, Florida, United States, 33414
      • Syzygy Research Solutions

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy Women; Once Daily Women's Probiotic Placebo	Dietary supplement: Once Daily Women's Probiotic; Active product; Other: Placebo; Placebo product

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4 months

Collaborators and Investigators

• Sponsor: Garden of Life, LLC
• Collaborators: Validcare, LLC
• Investigators: Study Director: Robert Kaufmann, MD, Validcare, LLC

Study record dates

Study Major Dates

• Study Start (Actual): February 9, 2022
• Primary Completion (Anticipated): September 30, 2022
• Study Completion (Anticipated): October 31, 2022

Study Registration Dates

• First Submitted: March 25, 2022
• First Submitted That Met QC Criteria: April 8, 2022
• First Posted (Actual): April 15, 2022

Study Record Updates

• Last Update Posted (Actual): August 3, 2022
• Last Update Submitted That Met QC Criteria: August 1, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Probiotics; Bacterial Vaginosis; Vaginal pH
• Other Study ID Numbers: VCODWP1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Data will not be shared with other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No