A Single Group Study to Evaluate the Effects of a Probiotic Supplement on Vaginal Health.

July 11, 2024 updated by: Love Wellness
This virtual single-group clinical trial aims to evaluate the effects of the Good Girl Probiotics supplement on vaginal health. Participants will take one capsule of the probiotic supplement daily for eight weeks. They will complete questionnaires at Baseline, after the first dose, and at the end of Weeks 2, 4, 6, and 8 to assess changes in vaginal pH, vaginal health, and urinary tract health.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Santa Monica, California, United States, 90404
        • Citruslabs

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Female at birth.
  • Aged 18+.
  • Interested in supporting a balanced vaginal pH, vaginal health, and urinary tract health.
  • Regularly experience symptoms of an unbalanced vagina, including an atypical smell, discharge, itching, swelling, irritation, pain during sex, and/or burning sensation while urinating.
  • Willing to avoid using products or medications that target vaginal or urinary tract health infections.
  • Willing to avoid other probiotics.
  • Able to follow the study protocol.

Exclusion Criteria:

  • Two or more bladder infections in six months or three or more infections in a year.
  • Recent surgeries or invasive treatments within the last six months.
  • Use of products or medications targeting vaginal or urinary tract health in the last 12 weeks.
  • Known allergies to the product ingredients.
  • Chronic health conditions impacting participation.
  • Pregnant, breastfeeding, or trying to conceive.
  • History of substance abuse.
  • Current or former smoker within the past six months.
  • Participation in another clinical trial.
  • Diagnosed vaginal or pelvic conditions.
  • Use of vaginal-related birth control (NuvaRing, IUD).
  • Changes in hormonal birth control in the last three months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Probiotic Supplement Group
Participants in this group will receive the Good Girl Probiotics supplement.
Dietary supplement: Good Girl Probiotics
Participants will take one capsule of the Good Girl Probiotics supplement daily in the morning for eight weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vaginal and Urinary Tract Health and Balance
Time Frame: Baseline, Week 2, Week 4, Week 6, Week 8
Assessment of vaginal and urinary tract health and balance through questionnaires completed by participants at Baseline, after the first dose, and at the end of Weeks 2, 4, 6, and 8.
Baseline, Week 2, Week 4, Week 6, Week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vaginal Environment and Odor
Time Frame: Baseline, Week 2, Week 4, Week 6, Week 8
Assessment of the vaginal environment and odor through questionnaires completed by participants at Baseline, after the first dose, and at the end of Weeks 2, 4, 6, and 8.
Baseline, Week 2, Week 4, Week 6, Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Love Wellness

Collaborators

Citruslabs

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 24, 2024

Primary Completion (Actual)

June 24, 2024

Study Completion (Actual)

June 24, 2024

Study Registration Dates

First Submitted

July 11, 2024

First Submitted That Met QC Criteria

July 11, 2024

First Posted (Actual)

July 17, 2024

Study Record Updates

Last Update Posted (Actual)

July 17, 2024

Last Update Submitted That Met QC Criteria

July 11, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 20433 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Women's Health

Clinical Trials on Good Girl Probiotics

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Chile

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe