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

Vaginal Health Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05330091
• Other study ID #: VCODWP1
• Status: Active, not recruiting
• Start date: February 9, 2022
• Est. completion date: October 31, 2022

Study information

• Verified date: August 2022
• Source: Garden of Life, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: October 31, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Vaginal Health

Intervention

Dietary Supplement:
• Once Daily Women's Probiotic
Active product

Other:
• Placebo
Placebo product

Locations

Country	Name	City	State
United States	Syzygy Research Solutions	Wellington	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Garden of Life, LLC	Validcare, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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