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Not yet recruiting 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.

No phase Interventional Bacterial Vaginosis Yeast Infection

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Prebiotic + Probiotic Supplement, Active Placebo Supplement, Excipient Placebo Supplement.
Who it may be relevant to
Registry conditions: Bacterial Vaginosis, Yeast Infection. Basic parameters: from 25 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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.

Overview

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 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)
  • Dietary supplement 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 d
  • Dietary supplement 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.

Primary outcome measures

  • Change in Vaginal Microbiome [Time frame: Baseline, Day 30]
Secondary outcome measures (2)
  • Change in Perceived Symptoms of Bacterial Vaginosis [Time frame: Baseline, Day 1, Day 7, Day 14, Day 21, Day 30]
  • Change in Perceived Symptoms of Yeast Infections [Time frame: Baseline, Day 1, Day 7, Day 14, Day 21, Day 30]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Citruslabs — Santa Monica

Identifiers

NCT: NCT06665126 · 20397

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗