Flourish Vaginal Care System to Establish Neovaginal Microbiome

Vaginal Biome Science56 enrolled

Overview

This study examines whether use of a commercially-available vaginal wellness system is able to establish a microbiome in transgender women.

Very little is known about the neovaginal microbiome, but it has been described as being a polymicrobial state similar to bacterial vaginosis (BV) in cis women. The Flourish Vaginal Care System is a commercially-available over-the-counter vaginal wellness kit that helps relieve symptoms of BV. This study is intended to determine whether that kit could also help transgender women who have recently undergone gender-confirming surgery to establish a neovaginal microbiome that is dominated by lactobacilli, as observed in healthy cis women. This could increase health and subjective satisfaction of the neovagina. This study examines the (neo)vaginal microbiome in transgender women with and without using Flourish, as well as a group of healthy cisgender women.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Neovaginal Microbiome

Interventions

Flourish Vaginal Care systemDEVICE

Flourish includes Restore® vaginal moisturizing gel, a Class II medical device cleared by the FDA, in addition to two other kit components

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Transgender women over age 18 who are preparing to undergo gender-confirmation surgery. 2. Healthy cisgender women ages 18-52 Exclusion Criteria: 1. Immunosuppressed 2. Known allergies or sensitivities to aloe vera or to other components of Restore®, Balance, or BiopHresh® 3. Known (neo)vaginal infection that is not yeast or BV at start of protocol 4. Inability to tolerate Restore gel by day 13 after surgery.

Locations (1)

Papillon Wellness Center

New Hope, Pennsylvania, United States

Outcomes

Primary Outcomes

Vaginal microbiome

Observation of changes in the composition of the vaginal fluid microbiome over six months using commercially available next-generation sequencing kit (16s rRNA). Biomes will be categorized to "community state type" (Ravel 2011), and genus- or species-level relative abundance will be compared.

Time frame: Collections at time 0, 6 weeks, and 6 months

Vaginal pH

Observation of changes in vaginal pH over six months by pH strip

Time frame: Collections at time 0, 6 weeks, and 6 months

Secondary Outcomes

VSQ

Responses to the Vulvovaginal Symptoms Questionnaire

Time frame: Collections at time 0, 6 weeks, and 6 months

Data from ClinicalTrials.gov

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