Effects of Gut Microflora on Cervico-vaginal Microenvironment in Women with Endometriosis (Original Version: Effetti Della Flora Intestinale Sul Microambiente Cervico-vaginale in Donne Con Endometriosi)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 123
- 试验地点
- 2
- 主要终点
- Comparison in the mean microbial diversity of the vaginal and gut microbiota between women with endometriosis and healthy volunteers, as assessed by Shannon Diversity Index (alpha-measure) and UniFrac analysis (beta measure), calculated in qiime2.
研究概览
简要总结
Endometriosis is a chronic inflammatory disease affecting approximately 10-15% of reproductive age women, and, in recent years, an association between this pathology and dysbiosis, either involving the gut or the genital microbiota, has been hypothesized.
Therefore, the aim of the study is to investigate the etiopathogenetic role of cervico-vaginal microbiota, and its relationship to the gut microbiota, in women with endometriosis. Furthermore, the effects of a multi-strain oral probiotic formulation will be evaluated on the composition of the genital microbiota in healthy women and patients with endometriosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •age between 20 and 40 years old;
- •clinical diagnosis of endometriosis via gynecological examination and transvaginal ultrasound (TVUS);
- •genital healthy condition as confirmed via gynecological examination.
排除标准
- •pre-menarche or menopause status;
- •diabetes, neoplastic diseases, urinary or genital infections in the past 6 months
- •bowel and/or liver disorders;
- •current treatment with oral contraceptive or progestins, prokinetics, antacids or proton pump in-hibitors;
- •sexual activity in the week before sampling;
- •recent or current antibiotic treatment (oral or topical);
- •the use of probiotics and/or prebiotics for three months before the enrolment.
结局指标
主要结局
Comparison in the mean microbial diversity of the vaginal and gut microbiota between women with endometriosis and healthy volunteers, as assessed by Shannon Diversity Index (alpha-measure) and UniFrac analysis (beta measure), calculated in qiime2.
时间窗: At the time of enrollment
Microbial diversity through Shannon diversity index and UniFrac analysis will be calculated from the number and type of bacterial species in the vaginal and gut microbiota as assessed by the sequencing of the hypervariable region (v3-v4) of the bacterial 16s rDNA via metagenomic analysis (Illumina MiSeq platform).
次要结局
- Changes in the mean microbial diversity (Shannon Diversity Index and UniFrac analysis) of the vaginal microbiota at two month supplementation, from baseline, of the probiotic product in either healthy women or women with endometriosis.(At the time of enrollment and after 2 months of probiotic supplementation)
研究者
Marisa Di Pietro
Professor in Microbiology
University of Roma La Sapienza