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

Sponsor
Garden of Life, LLC (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT05330091
Collaborator
Validcare, LLC (Other)
200
1
8.7
23.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Once Daily Women's Probiotic
  • Other: Placebo

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Garden of Life Once Daily Women's Probiotic: Vaginal pH and Quality of Life Study
Actual Study Start Date :
Feb 9, 2022
Anticipated Primary Completion Date :
Sep 30, 2022
Anticipated Study Completion Date :
Oct 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Healthy Women

Once Daily Women's Probiotic Placebo

Dietary Supplement: Once Daily Women's Probiotic
Active product

Other: Placebo
Placebo product

Outcome Measures

Primary Outcome Measures

  1. Vaginal pH [4 months]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 70 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Syzygy Research Solutions Wellington Florida United States 33414

Sponsors and Collaborators

  • Garden of Life, LLC
  • Validcare, LLC

Investigators

  • Study Director: Robert Kaufmann, MD, Validcare, LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Garden of Life, LLC
ClinicalTrials.gov Identifier:
NCT05330091
Other Study ID Numbers:
  • VCODWP1
First Posted:
Apr 15, 2022
Last Update Posted:
Aug 3, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Garden of Life, LLC

Study Results

No Results Posted as of Aug 3, 2022