UNRAVEL - The Role of Intestinal and Vaginal Microbiota, Estrogenic Activity, Metabolic Profile & Nutritional Status in Symptom Severity and Quality of Life of Portuguese Women With Endometriosis - an Exploratory Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Omega-3 index
研究概览
简要总结
Endometriosis (EMs) is one of the most prevalent benign gynaecological diseases, and it is an inflammatory oestrogen-dependent condition. Several authors have proposed that anatomical, genetic, endocrine, immunological, environmental, hormonal, and inflammatory factors may influence tissue implantation outside the uterus. An approach to EMs aetiology that involves defining a profile to the vaginal and gut microbiota, estrogenic activity, and exposure to xenoestrogens and also metabolic and nutritional status of women with EMs may help identify some important patterns to better characterize this disease and also to define more personalized nutritional strategies, also predicting patients' predisposition to therapy success. This is an observational study on premenopausal woman, diagnosed with EMs, who will be recruited on the outpatient gynaecology appointment, to evaluate the vaginal and intestinal microbiome, measure the total estrogenic activity, assess the metabolic biomarkers and the nutritional status.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Premenopause;
- •Diagnose of endometriosis by clinical and/or imaging criteria (associated adenomyosis is accepted);
- •BMI between 18.5 and 30.0 kg/m2
排除标准
- •Postmenopause;
- •Vegetarian diet;
- •Pregnancy or breastfeeding;
- •Continuous hormonal therapy for endometriosis;
- •Laparoscopic surgery for endometriosis purpose;
- •Gastrointestinal or vaginal infections;
- •Intaken antibiotics and/or probiotics within the last 8 weeks;
- •Medications to treat vaginal infections in the past 3 months.
结局指标
主要结局
Omega-3 index
时间窗: day 1
Mean/median of omega-3 index (uL) levels at baseline.
Alpha (α)-tocopherol
时间窗: day 1
Mean/median of α-tocopherol (ug/mL) levels at baseline.
Vaginal microbiome
时间窗: day 1
Characterization of the vaginal microbiome. Bacterial DNA will be extracted from cytology samples. 16S rRNA gene will be sequenced by next-generation sequencing (NGS). All the identified bacterial phyla, genus and species will be expressed in percentage.
Strogen levels
时间窗: day 1
Mean/median of total and free estrone (E1) and estradiol (E2) (ng E2-equivalents L-1) at baseline.
Total cholesterol
时间窗: day 1
Mean/median of total cholesterol (mg/dL) levels at baseline.
25-hydroxy vitamin D
时间窗: day 1
Mean/median of 25-hydroxy vitamin D (ng/mL) levels at baseline.
Intestinal microbiome
时间窗: day 1
Characterization of the intestinal microbiome at baseline. Bacterial DNA will be extracted from fecal samples. 16S rRNA gene will be sequenced by next-generation sequencing (NGS). All the identified bacterial phyla, genus and species will be expressed in percentage.
Insulin
时间窗: day 1
Mean/median of insulin (μU/mL) levels at baseline.
LDL cholesterol
时间窗: day 1
Mean/median of low-density lipoprotein (LDL) cholesterol (mg/dL) levels at baseline.
Fasting blood glucose
时间窗: day 1
Mean/median of fasting blood glucose levels (mg/dL) levels at baseline.
HDL cholesterol
时间窗: day 1
Mean/median of high-density lipoprotein (HDL) cholesterol (mg/dL) levels at baseline.
Ascorbic acid
时间窗: day 1
Mean/median of ascorbic acid (umol/L) levels at baseline.
次要结局
- Quality of life questionnaire(day 1)
- Symptoms severity(day 1)