Clinical Research Directory

Oral Multi-Strain Lactobacillus Probiotic for Women With Vaginal Dysbiosis

Many women have an imbalance in their vaginal bacteria that can cause discomfort, irritation, and repeat infections. In a healthy vagina, helpful Lactobacillus bacteria are the main group of microbes. When they decline, other bacteria such as Gardnerella can take over. Most probiotic treatments for this problem are applied vaginally, and many women find them inconvenient. This study tested a probiotic capsule taken by mouth. The capsule contained three Lactobacillus strains, taken from vaginal bacteria and from fermented foods. The study enrolled women aged 19 to 49 whose vaginal bacteria were in a borderline, mildly unbalanced state. Participants were randomly placed in one of three groups: a high-dose probiotic, a low-dose probiotic, or a placebo. They took their assigned product once a day for 12 weeks. Neither participants nor study staff knew who received which product. The study looked at whether the probiotic improved the balance of vaginal bacteria, vaginal acidity, and symptoms, and whether it was safe to take.

Large Algorithm Setting and Validation Study

In this pilot study, prospectively acquired clinician-collected and participant-collected vaginal swab specimens will be obtained from up to 1000 individuals with signs and symptoms of vaginitis to develop and validate a bacterial vaginosis diagnostic algorithm and evaluate the performance of the Nanopath assay. The Nanopath assay is an amplification-free molecular test that detects pathogens associated with vaginitis. The performance of the Nanopath assay will be assessed by comparing Nanopath assay results to previously FDA-cleared commercial tests and yeast culture.