Exploring the Effects of an Intravaginal Lactic Acid Gel on the Vaginal Microbiome

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 principal investigator will review the weekly schedule for the 1004 clinic and alert the attending physicians of patients who may be eligible for the study based on chart review. A HIPAA waiver will be required for this stage of recruitment, as the principal investigator would otherwise not be accessing these patient's charts. The attending physician staffing the 1004 clinic will ask the flagged patients if they are interested in learning about the study and review general study objectives with patients. If the patient is interested in participating, the research associates will approach the patient to more thoroughly screen, then conduct the informed consent process. Informed consent will be collected from every participant prior to the start of the study.

After obtaining informed consent, the research team will review standardized instructions for using the study medication with the patient and the research associate will provide a take-home kit including all of the study materials, including instructions for collecting each swab and for returning the samples. Samples will be self-collected by participants at their home at intervals specified in the study instructions. All materials provided to the patient will be pre-labeled with their study ID, protecting each participant's PHI. No collections will take place in-clinic. These materials include all surveys, patient's diary, and all swab vials. The three collection points are as follows: 1) baseline, prior to starting intervention (see below for recommendations on collecting baseline swab), 2) after completion of the intervention (30 days after baseline collection), and 3) 30 days after completion of the intervention (60 days after baseline collection).

All vaginal swabs must be frozen within 48 hours of collection. As such, the participants will be asked to send their samples within 24 hours in order to give adequate time for delivery to the storage facility and be asked to collect their specimens between Sunday and Thursday so samples can reach the facility during business hours. Freezing will occur at the research site. Each patient's study kit will include a prepaid shipping envelope, which the participant can use to mail or drive their specimen to the research team who will then place it in the freezer until it is ready for analysis.

The first phase of the study will include an assessment and classification of patients' vaginal microbiome prior to receipt of the intervention. To get the best representation of the participant's baseline microbiome, the participant will be asked to collect their baseline swab no sooner than 10 days after menses, as menses-induced changes in the microbiome have been shown to resolve after this time12. For similar reasons, if participants are being treated with an acute course of antibiotics or antifungals at the time of recruitment, they will be asked to wait 10 days after the completion of their medication course before collecting their baseline swab. There will be two additional time points for collection: collection 2) at the end of the 30 day intervention, and collection 3) 30 days after completion of the intervention.