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

Part of paid clinical trials in Santa Monica, California.

Sponsor
Happy V
Study ID
NCT06665126
Status
Not Yet Recruiting

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Conditions

  • Bacterial Vaginosis
  • Yeast Infection

Eligibility Criteria

Sex
FEMALE
Age
25 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Prebiotic + Probiotic Supplement — DIETARY_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 — DIETARY_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 — DIETARY_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.

Study Details

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.

Key Dates

Start date
Nov 1, 2024
Status verified
Oct 2024
Primary completion
May 1, 2025
Completion
May 30, 2025

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Test Product Group
    Participants in this group will receive the test product, a prebiotic and probiotic supplement.
  • Placebo Comparator: Active Placebo Group
    Participants in this group will receive an active placebo.
  • Placebo Comparator: Excipient Placebo Group
    Participants in this group will receive an excipient placebo.

Primary Outcome Measure

Change in Vaginal Microbiome [ Time Frame: Baseline, Day 30 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
CitruslabsSanta MonicaCalifornia90404
Patrick Renner, MSc
[email protected]
424-245-0284

Find similar trials in Santa Monica, CA

By research site
Citruslabs· Santa Monica, CA

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