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

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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Bacterial Vaginosis; Yeast Infection
• Intervention / Treatment: Dietary supplement: Prebiotic + Probiotic Supplement; Dietary supplement: Active Placebo Supplement; Dietary supplement: Excipient Placebo Supplement

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Patrick Renner, MSc; Phone Number: 4242450284; Email: hello@citruslabs.com

Study Locations

• United States
  • California
    • Santa Monica, California, United States, 90404
      • Citruslabs
      • Contact: Patrick Renner, MSc; Phone Number: 424-245-0284; Email: hello@citruslabs.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test Product Group; Participants in this group will receive the test product, a prebiotic and probiotic supplement.	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), and Cellulose (Vegetable Capsule). Participants take two capsules daily with food for 30 days.
Placebo Comparator: Active Placebo Group; Participants in this group will receive an active placebo.	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 days.
Placebo Comparator: Excipient Placebo Group; Participants in this group will receive an excipient placebo.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Vaginal Microbiome	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.	Baseline, Day 30

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Perceived Symptoms of Bacterial Vaginosis	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.	Baseline, Day 1, Day 7, Day 14, Day 21, Day 30
Change in Perceived Symptoms of Yeast Infections	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.	Baseline, Day 1, Day 7, Day 14, Day 21, Day 30

Collaborators and Investigators

• Sponsor: Happy V
• Collaborators: Citruslabs

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2024
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): May 30, 2025

Study Registration Dates

• First Submitted: October 7, 2024
• First Submitted That Met QC Criteria: October 28, 2024
• First Posted (Actual): October 30, 2024

Study Record Updates

• Last Update Posted (Actual): October 30, 2024
• Last Update Submitted That Met QC Criteria: October 28, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathologic Processes; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Disease Attributes; Genital Diseases, Female; Bacterial Infections; Bacterial Infections and Mycoses; Vaginitis; Infections; Communicable Diseases; Mycoses; Vaginosis, Bacterial; Vaginal Diseases
• Other Study ID Numbers: 20397

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No