跳至主要内容
临床试验/NCT05433909
NCT05433909招募中不适用

Microbiota and Immunoassay in Women With and Without Endometriosis: a Pilot Study

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年4月9日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
2
主要终点
Intestinal, vaginal and endometrial microbiota in patients with and without endometriosis

研究概览

简要总结

Endometriosis is an estrogen-dependent chronic inflammatory disease characterized by the presence of endometrial tissue outside the uterine cavity. This pathology has a prevalence of about 5-10% in reproductive-aged women. Endometriosis therapy uses two options: surgical or medical (hormonal) but none can be considered completely resolving. Related signs and symptoms include dysmenorrhea, dyspareunia, infertility, dysuria and dyschezia. In addition to typical gynecological symptoms, gastrointestinal symptoms (bloating, nausea, constipation, diarrhea and vomiting) affect up to 90% of patients with endometriosis. Despite its high prevalence and associated morbidity, its etiology is still unclear and is thought to be multifactorial, and genetic, hormonal, environmental and immunological factors contribute to it. Several studies have shown a significant association between abnormal immune response and maintenance of disease activity in women with endometriosis.

The microbiome contains all the genetic material of microbes, including bacteria, fungi, viruses and Archaea, which live inside the host and regulate various physiological functions. The set of these bacteria, fungi, viruses and Archaea is called a microbiota. The influence of the microbiome on immunomodulation and the development of various inflammatory diseases is well established. Conversely, little is known about the presence and composition of the microbiome in the female reproductive system and its role in the development of endometriosis or other gynecological conditions. Considering the altered inflammatory state typical of endometriosis, it seems logical to postulate a potential role of the microbiome in the etiopathogenesis of this pathology. Interestingly, the microbiome affects estrogen metabolism and estrogen affects the gut microbiome. Since endometriosis is an estrogen-dependent disease, a picture of intestinal dysbiosis resulting in abnormal circulating estrogen levels could potentially contribute to the development of this disease.

研究设计

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

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • BMI <30 kg / m2
  • no hormonal therapy (estrogen-progestin, progestogen, GnRH analogues) in progress for at least 1 month
  • the endometriosis group include women who will undergo surgery for endometriosis. The control group include women who will undergo surgery for other gynecological indications (i.e .: abdominal surgical emergencies, tubal infertility, non-endometriotic ovarian cysts) in which the presence of endometriosis will be excluded during the surgery.

排除标准

  • hormonal therapy in progress (estrogen-progestins, progestins, GnRH analogues)
  • antibiotic and / or probiotic therapy in the 8 weeks before the samples
  • pregnancy
  • menopausal state
  • BMI ≥ 30 kg / m2
  • presence of active systemic diseases, neoplasms, positive clinical history for autoimmune diseases, active vaginosis or positive history for pelvic inflammatory disease

结局指标

主要结局

Intestinal, vaginal and endometrial microbiota in patients with and without endometriosis

时间窗: 8 months

The intestinal, vaginal and endometrial microbiota in patients with endometriosis is different than the intestinal, vaginal and endometrial microbiota in patients without endometriosis

inflammatory, immunophenotype and hormonal status in patients with and without endometriosis

时间窗: 8 months

Differences of the inflammatory state, immunophenotype and hormonal status of the two groups of patients.

次要结局

  • Molecular, immunological characteristics of the inflammatory endometriosis environment(8 months)
  • Microbiota and sites, symptoms, hormonal treatments of endometriosis(8 months)
  • The impact of the various factors in determining the disease(8 months)

研究者

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

Direzione Ginecologia

Principal Investigator

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

研究点 (2)

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