跳至主要内容
临床试验/NCT05372770
NCT05372770已完成不适用

Pilot Study to Observe Effects of Using Flourish Vaginal Care System to Establish Neovaginal Microbiome After Gender-Confirmation Surgery

Vaginal Biome Science2 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2022年1月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
56
试验地点
2
主要终点
Vaginal microbiome

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Transgender women over age 18 who are preparing to undergo gender-confirmation surgery.
  • Healthy cisgender women ages 18-52

排除标准

  • Immunosuppressed
  • Known allergies or sensitivities to aloe vera or to other components of Restore®, Balance, or BiopHresh®
  • Known (neo)vaginal infection that is not yeast or BV at start of protocol
  • Inability to tolerate Restore gel by day 13 after surgery.

结局指标

主要结局

Vaginal microbiome

时间窗: Collections at time 0, 6 weeks, and 6 months

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.

Vaginal pH

时间窗: Collections at time 0, 6 weeks, and 6 months

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

次要结局

  • VSQ(Collections at time 0, 6 weeks, and 6 months)

研究者

发起方
Vaginal Biome Science
申办方类型
Other
责任方
Sponsor

研究点 (2)

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