Suspended

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

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Urogenital Diseases+8

+ Genital Diseases

+ Bacterial Infections and Mycoses

From 19 to 70 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: February 2022
See protocol details

Summary

Principal SponsorGarden of Life, LLC
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 9, 2022

Actual date on which the first participant was enrolled.

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.

Official TitleGarden of Life Once Daily Women's Probiotic: Vaginal pH and Quality of Life Study
Principal SponsorGarden of Life, LLC
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

200 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 19 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesBacterial Infections and MycosesBacterial InfectionsFemale Urogenital Diseases and Pregnancy ComplicationsGenital Diseases, FemaleInfectionsVaginal DiseasesVaginitisVaginosis, BacterialFemale Urogenital Diseases

Criteria

5 inclusion criteria required to participate
Age: 19-70 (21-70 for residents of Mississippi)

Non-menopausal women must have a regular menstrual cycle (26-32 days)

Using birth control

Sexually active (intercourse at least 2x/month)

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5 exclusion criteria prevent from participating
OCP or systemic hormonal contraception

No antibiotic treatment for at least 30 days

No active vaginal infection or symptoms of infection

No probiotic use for 30 days

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Syzygy Research Solutions

Wellington, United StatesOpen Syzygy Research Solutions in Google Maps
SuspendedOne Study Center