Characterizing the Microbiome in Postmenopausal Women With Vulvar Lichen Sclerosus
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
- 否
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
Melissa Mauskar
Associate Professor of Medicine
University of Texas Southwestern Medical Center
