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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Endometriosis
- Sponsor
- Universidade Nova de Lisboa
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Omega-3 index
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Premenopause;
- •Diagnose of endometriosis by clinical and/or imaging criteria (associated adenomyosis is accepted);
- •BMI between 18.5 and 30.0 kg/m2
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Omega-3 index
Time Frame: day 1
Mean/median of omega-3 index (uL) levels at baseline.
Alpha (α)-tocopherol
Time Frame: day 1
Mean/median of α-tocopherol (ug/mL) levels at baseline.
Vaginal microbiome
Time Frame: 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
Time Frame: day 1
Mean/median of total and free estrone (E1) and estradiol (E2) (ng E2-equivalents L-1) at baseline.
Total cholesterol
Time Frame: day 1
Mean/median of total cholesterol (mg/dL) levels at baseline.
25-hydroxy vitamin D
Time Frame: day 1
Mean/median of 25-hydroxy vitamin D (ng/mL) levels at baseline.
Intestinal microbiome
Time Frame: 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
Time Frame: day 1
Mean/median of insulin (μU/mL) levels at baseline.
LDL cholesterol
Time Frame: day 1
Mean/median of low-density lipoprotein (LDL) cholesterol (mg/dL) levels at baseline.
Fasting blood glucose
Time Frame: day 1
Mean/median of fasting blood glucose levels (mg/dL) levels at baseline.
HDL cholesterol
Time Frame: day 1
Mean/median of high-density lipoprotein (HDL) cholesterol (mg/dL) levels at baseline.
Ascorbic acid
Time Frame: day 1
Mean/median of ascorbic acid (umol/L) levels at baseline.
Secondary Outcomes
- Quality of life questionnaire(day 1)
- Symptoms severity(day 1)