A Study to Evaluate the Effects of a Prebiotic and Probiotic Supplement to Provide Relief From Symptoms Associated With Bacterial Vaginosis and Yeast Infections.

Not Applicable

Not yet recruiting

• Conditions: Bacterial Vaginosis; Yeast Infection

• Registration Number: NCT06665126
• Lead Sponsor: Happy V

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-07
• Study First Submitted QC: 2024-10-28
• Last Update Submitted: 2024-10-28
• Study First Posted: 2024-10-30
• Last Update Posted: 2024-10-30
• Study Start: 2024-11-01
• Primary Completion: 2025-05-01
• Study Completion: 2025-05-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

• Women
• Age 25+
• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Vaginal Microbiome	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 Outcome Measures

Name	Time	Method
Change in Perceived Symptoms of Bacterial Vaginosis	Baseline, Day 1, Day 7, Day 14, Day 21, Day 30	This outcome measures the change in symptoms associated with bacterial vaginosis and yeast infections (e.g., itchiness, odor, abnormal discharge) as reported by participants through questionnaires.
Change in Perceived Symptoms of Yeast Infections	Baseline, Day 1, Day 7, Day 14, Day 21, Day 30	This outcome measures the change in symptoms associated with bacterial vaginosis and yeast infections (e.g., itchiness, odor, abnormal discharge) as reported by participants through questionnaires.

Trial Locations

Locations (1)

Citruslabs; 🇺🇸 Santa Monica, California, United States