Bacterial Vaginosis, Yeast Infection
Conditions
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.
Interventions
DIETARY_SUPPLEMENTPrebiotic + Probiotic Supplement
This intervention includes a combination of prebiotics and probiotics designed to promote vaginal and digestive health. The supplement contains Biotin, Lactobacillus acidophilus (as LA-14®), Bifidobacterium lactis (HN019™), Lactobacillus rhamnosus (as HN001™), Lactobacillus crispatus (as CCFM1110™), Lactobacillus gasseri (as HLG13™), Lactobacillus reuteri (as HR7™), Bacillus subtilis (as DE111®), PreforPro®, White Rice Flour, Magnesium Stearate (Vegetable Source), Silicon Dioxide (Bamboo Source), and Cellulose (Vegetable Capsule). Participants take two capsules daily with food for 30 days.
DIETARY_SUPPLEMENTActive Placebo Supplement
The active placebo supplement contains similar probiotic strains without the prebiotic component. Ingredients include Biotin, Lactobacillus acidophilus, Bifidobacterium lactis, Lactobacillus rhamnosus, Lactobacillus crispatus, Lactobacillus gasseri, Lactobacillus reuteri, Bacillus subtilis, Inulin (from Chicory Root), White Rice Flour, Magnesium Stearate (Vegetable Source), Silicon Dioxide (Bamboo Source), and Cellulose (Vegetable Capsule). Participants take two capsules daily with food for 30 days.
DIETARY_SUPPLEMENTExcipient Placebo Supplement
The excipient placebo supplement contains no active ingredients related to prebiotics or probiotics. It includes White Rice Flour, Magnesium Stearate (Vegetable Source), and Cellulose (Vegetable Capsule). Participants take two capsules daily with food for 30 days.
Sponsors
Happy V
Citruslabs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, 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.
Intervention model description
Participants will be randomized into 3 groups (test product, active placebo, excipient placebo).
Eligibility
Sex/Gender
FEMALE
Age
25 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed