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

August 20, 2024 updated by: Love Wellness
This is a virtual single-group clinical trial lasting 8 weeks to evaluate the effects of a probiotic vaginal suppository on vaginal health. Participants will use the Flora Power suppository daily for 5 consecutive days when experiencing common signs of vaginal imbalance. They will complete questionnaires and vaginal pH tests before and after product use.

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 maintaining a healthy vaginal environment.
  • Experience common signs of vaginal imbalance (e.g., malodor, irritation).
  • Willing to avoid other vaginal products and follow study protocol.

Exclusion Criteria:

  • Recent surgeries or invasive treatments.
  • Use of vaginal health products in the last 12 weeks.
  • Allergies to product ingredients.
  • Chronic health conditions impacting participation.
  • Pregnant, breastfeeding, or trying to conceive.
  • History of substance abuse or smoking.
  • Currently participating in another clinical trial.

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: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Flora Power Probiotic Vaginal Suppository
Participants will use the Flora Power suppository once daily at bedtime for 5 consecutive days when they feel they are experiencing any of the common signs of vaginal imbalance like vaginal malodor, vaginal irritation, and/or vaginal itching.
Dietary supplement: Flora Power Probiotic Vaginal Suppository
The suppository contains Microcrystalline Cellulose, Ascorbic Acid, Vitamin C, Gelatin Capsule, Vaginal Probiotic Blend (Lactobacillus fermentum LF61, Lactobacillus acidophilus LA85, Lactobacillus plantarum Lp90), Magnesium Stearate, and Silicon Dioxide.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect on Vaginal pH and Health
Time Frame: Baseline, Day 6 (24 hours after the last suppository insertion)
Measure the change in vaginal pH levels with a test strip from baseline to 24 hours after the 5-day intervention period.
Baseline, Day 6 (24 hours after the last suppository insertion)
Effect on Vaginal pH and Health
Time Frame: Baseline, Day 6 (24 hours after the last suppository insertion)
Measure the change in overall vaginal health from baseline to 24 hours after the 5-day intervention period with a questionnaire.
Baseline, Day 6 (24 hours after the last suppository insertion)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participant Perception of Vaginal Freshness and Odor
Time Frame: Baseline, Day 2, Day 5
Evaluate participants' perceptions of the vaginal suppository's impact on vaginal freshness and odor, as well as the support of a calm, soothed, and balanced vaginal environment. This outcome measure is assessed with questionnaires.
Baseline, Day 2, Day 5

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)

May 10, 2024

Primary Completion (Actual)

July 10, 2024

Study Completion (Actual)

July 10, 2024

Study Registration Dates

First Submitted

July 11, 2024

First Submitted That Met QC Criteria

August 20, 2024

First Posted (Actual)

August 21, 2024

Study Record Updates

Last Update Posted (Actual)

August 21, 2024

Last Update Submitted That Met QC Criteria

August 20, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 20434

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.

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