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NCT Number: 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.

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.

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Key information

Conditions

Bacterial Vaginosis Bacterial Infections Bacterial Infections and Mycoses Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infections Urogenital Diseases Vaginal Diseases Vaginitis Vaginosis, Bacterial Yeast Infection

Age range

25 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Change in Vaginal Microbiome

    Time frame: 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 outcomes

  1. Change in Perceived Symptoms of Bacterial Vaginosis

    Time frame: 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.

  2. Change in Perceived Symptoms of Yeast Infections

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Patrick Renner, MSc

CONTACT

[email protected]

4242450284

Sponsors and collaborators

Lead sponsor

Happy V

Industry

Collaborators

  • Citruslabs

Registry information

Official study 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.

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 30, 2024
Registry last updated
Oct 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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