A Study to Evaluate the Effects of a Prebiotic and Probiotic Supplement to Provide Relief From Symptoms Associated With Bacterial Vaginosis and Yeast Infections.
NCT ID: NCT06665126
Last Updated: 2024-10-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
120 participants
INTERVENTIONAL
2024-11-01
2025-05-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Test Product Group
Participants in this group will receive the test product, a prebiotic and probiotic supplement.
Prebiotic + 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.
Active Placebo Group
Participants in this group will receive an active placebo.
Active 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.
Excipient Placebo Group
Participants in this group will receive an excipient placebo.
Excipient 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.
Interventions
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Prebiotic + 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.
Active 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.
Excipient 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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
25 Years
FEMALE
No
Sponsors
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Citruslabs
INDUSTRY
Happy V
INDUSTRY
Responsible Party
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Locations
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Citruslabs
Santa Monica, California, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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20397
Identifier Type: -
Identifier Source: org_study_id
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