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NOT YET RECRUITING
NCT06665126
NA

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

Sponsor: Happy V

View on ClinicalTrials.gov

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.

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.

Key Details

Gender

FEMALE

Age Range

25 Years - Any

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2024-11-01

Completion Date

2025-05-30

Last Updated

2024-10-30

Healthy Volunteers

No

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), and Cellulose (Vegetable Capsule). Participants take two capsules daily with food for 30 days.

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.

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.

Locations (1)

Citruslabs

Santa Monica, California, United States