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

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.