NCT06236893

Randomized, Double-Blind Placebo-Controlled Trial to Assess Overall User Experience of a Synbiotic Vaginal Suppository

A Randomized, Double-Blind Placebo-Controlled Trial to Assess The Overall User Experience of a Synbiotic Vaginal Suppository

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Seed Health · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the impact of a personal care product on vaginal health in individuals with a self-reported history of vaginal discomforts such as malodor, bothersome discharge, itching, irritation, and dryness. The personal care product, VH-01 contains a prebiotic and three distinct strains of Lactobacillus crispatus, a microbe commonly found in healthy vaginal microbiomes. The study will be a randomized, placebo-controlled trial where the test product will be compared to a placebo in a 2:1 manner. Participants will be asked to complete online questionnaires and provide vaginal samples to assess microbial communities. The aims of this study are to assess: 1. The user experience and acceptability of VH-01 vaginal suppository vs. placebo. 2. Attitudes and perceptions of VH-01 vaginal suppository usage vs. placebo. 3. Health-related quality of life during the use of VH-01 vaginal suppository vs. placebo. 4. Changes in self-perceived vaginal discomforts during the use of VH-01 vaginal suppository vs. placebo.

Detailed description

The vaginal microbiome is a community of microorganisms that live inside of the vagina. Studies have shown that vaginal microbiomes can be classified into one of five community state types (CSTs) known as: CST I, II, III, IV, and V. CSTs are determined based on the taxonomic composition of the vaginal microbiome. CST I, dominated by Lactobacillus crispatus, is considered optimal and is significantly associated with vaginal health. Lactobacillus crispatus produces lactic acid and other compounds that maintain an optimal vaginal pH, which discourages the growth of harmful microbes that lead to disruptions in the vaginal microbial ecosystem. These disruptions may increase vaginal discomforts such as vaginal malodor, discharge, itching, irritation, and dryness. VH-01 is a multi-strain vaginal synbiotic designed to seed and sustain an optimal and protective CST I vaginal ecology. The product delivers an ecology of complimentary Lactobacillus crispatus and synbiotic ingredients to promote an optimal vaginal ecology. The strains were selected to confer maximal vaginal microbiome stability in response to potential perturbations such as menstruation, sex, exercise, medication and other environmental influences. The purpose of this study is to determine whether vaginal health can be influenced by a novel personal care product comprised of a prebiotic, and multiple strains of Lactobacillus crispatus associated with a stable vaginal microbiome.

Conditions

• Vaginal Personal Care

Interventions

Type	Name	Description
OTHER	VH-01 vaginal suppository tablet	Participants will be instructed to take VH-01 Days 1, 4, 7, 14, and 21 of Month 1 and Days 1 and 14 of Months 2 and 3.
OTHER	Placebo vaginal suppository tablet	Participants will be instructed to take the placebo on Days 1, 4, 7, 14, and 21 of Month 1 and Days 1 and 14 of Months 2 and 3.

Timeline

• Start date: 2024-01-29
• Primary completion: 2024-07-31
• Completion: 2024-07-31
• First posted: 2024-02-01
• Last updated: 2025-05-31

Locations

1 site across 1 country: United States