Status:

UNKNOWN

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

Lead Sponsor:

Garden of Life, LLC

Collaborating Sponsors:

Validcare, LLC

Conditions:

Vaginal Health

Eligibility:

FEMALE

19-70 years

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 y...

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 y...

Eligibility Criteria

Inclusion

  • 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)
  • Agree to not introduce any other probiotic during the three months of study

Exclusion

  • 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
  • Routine douching (except for immediately after menses)

Key Trial Info

Start Date :

February 9 2022

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

October 31 2022

Estimated Enrollment :

200 Patients enrolled

Trial Details

Trial ID

NCT05330091

Start Date

February 9 2022

End Date

October 31 2022

Last Update

August 3 2022

Active Locations (1)

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Syzygy Research Solutions

Wellington, Florida, United States, 33414