Clinical trial NCT06665126: A Study to Evaluate the Effects of a Prebiotic and Probiotic Supplement to Provide Relief From Symptoms Associated With Bacterial Vaginosis and Yeast Infections.
Official title: A Triple-Group Randomized Controlled Trial to Evaluate the Effects of a Prebiotic and Probiotic Supplement to Provide Relief From Symptoms Associated With Bacterial Vaginosis and Yeast Infections.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Bacterial Vaginosis
Yeast Infection
Lead sponsor: Happy V
Sponsor class: INDUSTRY
Collaborators: name: Citruslabs
First posted: 2024-10-30
Enrollment: 120
Sex: FEMALE
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized into 3 groups (test product, active placebo, excipient placebo).
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Vaginal Microbiome
timeFrame: Baseline, Day 30
Secondary outcomes:
measure: Change in Perceived Symptoms of Bacterial Vaginosis
timeFrame: Baseline, Day 1, Day 7, Day 14, Day 21, Day 30
measure: Change in Perceived Symptoms of Yeast Infections
timeFrame: Baseline, Day 1, Day 7, Day 14, Day 21, Day 30
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Citruslabs
state: California
Study officials:
References: