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临床试验/NCT05147129
NCT05147129已完成不适用

Characterizing the Microbiome in Postmenopausal Women With Vulvar Lichen Sclerosus

University of Texas Southwestern Medical Center1 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2021年9月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
17
试验地点
1
主要终点
Operational taxonomic unit (OTU) relative abundance

研究概览

简要总结

Vulvar lichen sclerosus (LS) is a chronic inflammatory disease, often diagnosed at late stages after scarring has obliterated normal vulvar architecture and severely affected a woman's quality of life. First line therapy for vulvar LS is ultrapotent topical steroids. If left untreated, this condition can cause complete stenosis of the vaginal introitus and 5% of patients may develop squamous cell carcinoma (SCC).

Lichen sclerosus is more common in pre-pubertal children and in post-menopausal women suggesting that hormonal shifts may contribute to disease pathogenesis. Small studies in children with LS have also shown that the microbiome is altered in LS. Little is known about the skin microbiota in postmenopausal patients with vulvar LS.

To determine if the microbiome is altered in vulvar skin of postmenopausal patients with LS, this study will use 16s sequencing to broadly characterize the microbiota of vulvar skin with LS compared to control vulvar skin. The study team hypothesizes that patients with vulvar LS will have a unique vulvar microbial signature compared to age-matched controls. This study also seeks to elucidate differences in the vulvar microbiome of patients with LS after treatment of their underlying condition. The study team hypothesizes that the vulvar microbiome will change after treatment for vulvar LS.

Vulvar dermatoses are an understudied area in dermatology with limited therapeutic options. Innumerable women often suffer in silence with vulvar LS. The long-term goal of this work is to understand factors that contribute to vulvar LS so that intervention may be undertaken before irreversible scarring and SCC develop.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

性别
Female
接受健康志愿者

入选标准

  • Postmenopausal

排除标准

  • Use of systemic hormone replacement
  • Use of antibiotics in prior three months
  • Urinary incontinence, which is defined by: 1) two incontinence episodes in the past three days and also 2) regular incontinence over the past three months that has necessitated use of incontinence protection garments

结局指标

主要结局

Operational taxonomic unit (OTU) relative abundance

时间窗: 10-14 weeks after beginning treatment for vulvar lichen sclerosus, if applicable

Similar 16s sequencing reads will be clustered into OTUs and relative abundance of OTUs in the samples under investigation will be reported

次要结局

  • Alpha and beta diversity(10-14 weeks after beginning treatment for vulvar lichen sclerosus, if applicable)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Melissa Mauskar

Associate Professor of Medicine

University of Texas Southwestern Medical Center

研究点 (1)

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