A Study to Evaluate the Effects of a Prebiotic and Probiotic Supplement to Provide Relief From Symptoms Associated With Bacterial Vaginosis and Yeast Infections.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 120
- Locations
- 2
- Primary Endpoint
- Change in Vaginal Microbiome
Study Overview
Brief Summary
This virtual randomized controlled trial evaluates the efficacy of a prebiotic and probiotic supplement in providing relief from symptoms associated with bacterial vaginosis and yeast infections. Participants will be randomized into three groups-test product, active placebo, and excipient placebo-and will take two capsules daily for 30 days. The study will assess the effects on vaginal microbiome, symptoms of bacterial vaginosis and yeast infections, and overall vaginal health.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Masking Description
This study employs a triple-blind design to ensure unbiased results. The three groups in the study (test product, active placebo, and excipient placebo) will receive capsules that are identical in appearance, taste, and packaging. Neither the participants, the investigators, nor the outcomes assessors will know which group the participants are assigned to.
Eligibility Criteria
- Ages
- 25 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Self-reported concerns symptoms associated with bacterial vaginosis or candida overgrowth, including itchiness, redness, abnormal discharge, and an unpleasant odor.
- •Suffers from digestive issues, including bloating, gas, or other digestive discomfort.
- •Generally healthy - do not live with any uncontrolled chronic diseases.
- •Willing to avoid using any vaginal health-related medications, supplements, and herbal remedies for the duration of this study.
- •If taking oral supplements or herbal remedies targeted at vaginal health, has been consistently taking these for at least 3 months prior to starting the study and is willing to maintain this routine for the study duration.
Exclusion Criteria
- •Any pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders
- •Planning to undergo any procedure related to their vaginal health.
- •Started any new medications or supplements that target vaginal health in the past 3 months.
- •Anyone with known severe allergic reactions that require the use of an Epi-Pen, or any known allergies to any of the product ingredients
- •Women who are pregnant, breastfeeding, or attempting to conceive
- •Unwilling to follow the study protocol
- •Anyone who has undergone any surgeries or invasive treatments in the last three months or has any planned during the study period.
Arms & Interventions
Test Product Group
Participants in this group will receive the test product, a prebiotic and probiotic supplement.
Intervention: Prebiotic + Probiotic Supplement (Dietary Supplement)
Active Placebo Group
Participants in this group will receive an active placebo.
Intervention: Active Placebo Supplement (Dietary Supplement)
Excipient Placebo Group
Participants in this group will receive an excipient placebo.
Intervention: Excipient Placebo Supplement (Dietary Supplement)
Outcomes
Primary Outcomes
Change in Vaginal Microbiome
Time Frame: Baseline, Day 30
This outcome measures the change in vaginal microbiome parameters from Baseline to Day 30. The vaginal microbiome will be assessed using microbiome sequencing at both Baseline and Day 30.
Secondary Outcomes
- Change in Perceived Symptoms of Bacterial Vaginosis(Baseline, Day 1, Day 7, Day 14, Day 21, Day 30)
- Change in Perceived Symptoms of Yeast Infections(Baseline, Day 1, Day 7, Day 14, Day 21, Day 30)