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

NCT06665126 | Not Yet Recruiting

• 1 other identifier: 20397
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bacterial Vaginosis; Yeast Infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in Perceived Symptoms of Bacterial Vaginosis

  Baseline, Day 1, Day 7, Day 14, Day 21, Day 30

• Change in Perceived Symptoms of Yeast Infections

  Baseline, Day 1, Day 7, Day 14, Day 21, Day 30

Study Arms (3)

Test Product Group

EXPERIMENTAL

Participants in this group will receive the test product, a prebiotic and probiotic supplement.

Dietary Supplement: Prebiotic + Probiotic Supplement

Active Placebo Group

PLACEBO COMPARATOR

Participants in this group will receive an active placebo.

Dietary Supplement: Active Placebo Supplement

Excipient Placebo Group

PLACEBO COMPARATOR

Participants in this group will receive an excipient placebo.

Dietary Supplement: Excipient Placebo Supplement

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.

Test Product Group

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.

Active Placebo Group

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.

Excipient Placebo Group

Eligibility Criteria

• Age: 25 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Happy V: lead
• Citruslabs: collaborator

Study Sites (1)

Citruslabs

Santa Monica, California, 90404, United States

Location

MeSH Terms

Conditions

Vaginosis, Bacterial

Interventions

Prebiotics

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Dietary Fiber; Dietary Carbohydrates; Carbohydrates; Polysaccharides, Bacterial; Polysaccharides; Food; Diet, Food, and Nutrition; Physiological Phenomena; Dietary Supplements; Food and Beverages

Central Study Contacts

Patrick Renner, MSc

CONTACT

4242450284; hello@citruslabs.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This study employs a triple-blind design to ensure unbiased results. The three groups in the study (test product, active placebo, and excipient placebo) will receive capsules that are identical in appearance, taste, and packaging. Neither the participants, the investigators, nor the outcomes assessors will know which group the participants are assigned to.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will be randomized into 3 groups (test product, active placebo, excipient placebo).

Study Record Dates

• First Submitted: October 7, 2024
• First Posted: October 30, 2024
• Study Start: November 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 30, 2025
• Last Updated: October 30, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)