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

NCT05330091 | Unknown DMC

• 1 other identifier: VCODWP1
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Vaginal Health

Keywords

Probiotics; Bacterial Vaginosis; Vaginal pH

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Healthy Women

Once Daily Women's Probiotic Placebo

Dietary Supplement: Once Daily Women's Probiotic; Other: Placebo

Interventions

Once Daily Women's Probiotic DIETARY_SUPPLEMENT

Active product

Healthy Women

Placebo OTHER

Placebo product

Healthy Women

Eligibility Criteria

• Age: 19 Years - 70 Years
• Gender Eligibility Details: Health female population
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The population for this study will be generally healthy adults (19-70 years old) willing to consume ODWP or placebo of whom half have a history of bacterial vaginosis, and half who do not have such a history. Between 20-30% of the total population will be post- menopausal and will be distributed relatively equally between the 4 groups in the study.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Garden of Life, LLC: lead
• Validcare, LLC: collaborator

Study Sites (1)

Syzygy Research Solutions

Wellington, Florida, 33414, United States

Location

MeSH Terms

Conditions

Vaginosis, Bacterial

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Robert Kaufmann, MD

  Validcare, LLC

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2022
• First Posted: April 15, 2022
• Study Start: February 9, 2022
• Primary Completion: September 30, 2022
• Study Completion: October 31, 2022
• Last Updated: August 3, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)