NCT04118049

Vaginal Probiotics and Pessaries and Their Impact on the Vaginal Microenvironment

The Effect of Vaginal Probiotics on the Vaginal Microenvironment in Patients Using Vaginal Pessaries: a Randomized Controlled Trial.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 141 (actual)
• Sponsor: Hartford Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

Summary

In this study, the investigators are evaluating the effect of vaginal probiotics on the bothersome side effects of pessary use and the impact on the vaginal microenvironment (lactobacilli, anaerobic bacteria, mobiluncus bacteria, WBCs, cellular debris, epithelial cells, and BVAB-1), and inflammatory environment (cytokines).

Conditions

• Pelvic Organ Prolapse
• Inflammatory Response
• Dysbiosis

Interventions

Type	Name	Description
OTHER	BiopHreshTM vaginal probiotic supplement (Good Clean Love, Inc. Eugene, OR) and RestoreTM gel.	BiopHreshTM is a vaginal probiotic supplement that is offered over the counter and contains four different lactobacilli strains (L. crispatus, L. gasseri, L. jensenii, and L. rhamnosus). RestoreTM is a moisturizing personal lubricant that has been on the market for three years. Participants will use 1 probiotic capsule with RestoreTM gel nightly three times weekly.
OTHER	Standard Care	Standard care arm is standard care for pessary use. Pessary maintenance will be performed standardly by their provider.

Timeline

• Start date: 2019-10-30
• Primary completion: 2021-05-30
• Completion: 2021-05-30
• First posted: 2019-10-07
• Last updated: 2022-03-25

Locations

1 site across 1 country: United States