Exploring the Effects of an Intravaginal Lactic Acid Gel on the Vaginal Microbiome
Queen's Medical Center
Summary
This project aims to investigate if the contraceptive method, Phexxi, causes changes to the composition of the vaginal microbiome. The investigators hypothesize that regular use of Phexxi will cause increased colonization of lactic acid-producing lactobacilli, which could have positive effects in the way of preventing recurrent episodes of BV and candida infections.
Description
This is a single center, prospective trial, which comprises of a pre-post study design that will be looking at the vaginal microbiome makeup of participants before and after a four-week course of Phexxi. The primary outcomes will be an increase in lactic acid-forming lactobacilli, as well as a decrease in patient-reported symptoms of vulvovaginitis. This study will be based at the Queen's Medical Center (QMC), POB1 Suite 1004. Eligible patients will be approached by participating clinicians (all doctors providing care at the 1004 clinic) to assess interest in study participation.. The princip…
Eligibility
- Age range
- 18–54 years
- Sex
- Female
- Healthy volunteers
- Yes
Inclusion Criteria: * Age 18-54 * Female * Pre-menopausal * Can speak and read in English * Displays capacity for informed consent * Has had 2 or more documented and/or self-reported episodes of symptomatic BV or candida infection in the last year, requiring, over-the-counter or prescription treatment Exclusion Criteria: * Pregnant or trying to become pregnant * Post-menopausal * Using NuvaRing device * A past medical history of kidney disease, recurrent UTI, and/or urinary tract abnormalities * Current UTI * Using Phexxi as a contraceptive during the collection period of the study
Interventions
- DrugPhexxi
intravaginal gel twice weekly for 4 weeks.
Location
- Queens Medical Center, 1004 Clinic POB1Honolulu, Hawaii