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

NCT ID: NCT05330091

Last Updated: 2022-08-03

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-02-09
• Study Completion Date: 2022-10-31

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.

Conditions

Vaginal Health

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Healthy Women

Once Daily Women's Probiotic Placebo

Once Daily Women's Probiotic

Intervention Type: DIETARY_SUPPLEMENT

Active product

Placebo

Intervention Type: OTHER

Placebo product

Interventions

Once Daily Women's Probiotic

Active product

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Placebo product

Intervention Type: OTHER

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)

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Validcare, LLC

UNKNOWN

Sponsor Role: collaborator

Garden of Life, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Kaufmann, MD

Role: STUDY_DIRECTOR

Validcare, LLC

Locations

Syzygy Research Solutions

Wellington, Florida, United States

Countries

United States

Other Identifiers

VCODWP1

Identifier Type: -

Identifier Source: org_study_id