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

Launched by GARDEN OF LIFE, LLC · Apr 8, 2022

Keywords

ClinConnect 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. 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 e...

Gender

FEMALE

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)