Microbiome and Immunologic Analysis of the Lower and Upper Female Reproductive Tract in Women With Endometriosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Microbiome composition in genital tract and gastrointestinal tract
研究概览
简要总结
The primary goal of this study is to assess differences in the microbiome between women with and without endometriosis.
A second goal of this study is to assess immunologic differences between the eutopic (within the uterus) and ectopic (outside of the uterus) endometrial tissue in women with endometriosis.
In order to investigate these areas of interest, 25 women with endometriosis and 25 women without endometriosis will be enrolled. All women will be undergoing a previously scheduled surgical procedure at which time presence or absence of endometriosis will be confirmed and specimens will be obtained.
详细描述
Endometriosis is a chronic gynecologic condition where implants of endometrial glands and stroma are present outside of the uterus. It occurs in 6-10% of women of reproductive age and is characterized by dysmenorrhea, chronic pelvic pain, dyspareunia, or infertility. In addition to symptom burden, there are significant direct costs related to diagnosis and treatment of disease, as well as indirect costs related to absenteeism from school and work, loss of productivity, and unemployment. The estimated national economic burden in the United States related to these costs is approximately 78 billion dollars per year. While clinical signs and symptoms may be suggestive of endometriosis, the gold standard for diagnosis requires surgical confirmation of disease.
The pathogenesis of endometriosis is complex and likely multifactorial with genetic, epigenetic, environmental, and immunologic factors. An increasing number of studies have also suggested the role of the microbiome in human health and development of disease. This study aims to investigate possible differences in the microbiome and immunologic factors that could contribute to pathogenesis of this disease. Findings from this study could potentially contribute to the development of of a less invasive, non-surgical diagnostic test for endometriosis.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females, age 18 years or older
- •Undergoing laparoscopy (conventional or robotic) with or without hysterectomy for non-cancer indications and including women from two groups:
- •Suspected endometriosis
- •Elective salpingectomy or tubal ligation or abnormal uterine bleeding
- •Understands study procedures
- •Willing and able to provide signed informed consent
排除标准
- •Postmenopausal
- •Currently pregnant or lactating
- •Prior hysterectomy or oophorectomy
- •Undergoing hysterectomy via vaginal or abdominal approach
- •Undergoing hysterectomy or laparoscopy for suspected malignancy
- •Use of antibiotics within 2 weeks prior to surgery
- •Use of hormone therapy for endometriosis or contraception within 4 weeks prior to surgery
- •Diagnosis or treatment of vaginitis during the past 6 months prior to surgery
- •Personal history of autoimmune or inflammatory disease
结局指标
主要结局
Microbiome composition in genital tract and gastrointestinal tract
时间窗: At time of surgery
次要结局
- Immunostaining of eutopic and ectopic endometrium for immune factors, immune cells, and fibrosis(At time of surgery)
研究者
Marina R. Walther-Antonio
Assistant Professor of Surgery
Mayo Clinic