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.
Study Type
OBSERVATIONAL
Enrollment
60
NOVA Medical School|Faculdade de Ciências Médicas, Universidade NOVA de Lisboa
Lisbon, Portugal
Vaginal microbiome
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.
Time frame: day 1
Intestinal microbiome
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.
Time frame: day 1
Strogen levels
Mean/median of total and free estrone (E1) and estradiol (E2) (ng E2-equivalents L-1) at baseline.
Time frame: day 1
Fasting blood glucose
Mean/median of fasting blood glucose levels (mg/dL) levels at baseline.
Time frame: day 1
Insulin
Mean/median of insulin (μU/mL) levels at baseline.
Time frame: day 1
Total cholesterol
Mean/median of total cholesterol (mg/dL) levels at baseline.
Time frame: day 1
HDL cholesterol
Mean/median of high-density lipoprotein (HDL) cholesterol (mg/dL) levels at baseline.
Time frame: day 1
LDL cholesterol
Mean/median of low-density lipoprotein (LDL) cholesterol (mg/dL) levels at baseline.
Time frame: day 1
25-hydroxy vitamin D
Mean/median of 25-hydroxy vitamin D (ng/mL) levels at baseline.
Time frame: day 1
Ascorbic acid
Mean/median of ascorbic acid (umol/L) levels at baseline.
Time frame: day 1
Alpha (α)-tocopherol
Mean/median of α-tocopherol (ug/mL) levels at baseline.
Time frame: day 1
Omega-3 index
Mean/median of omega-3 index (uL) levels at baseline.
Time frame: day 1
Quality of life questionnaire
Median of quality of life by the Quality of Life Scale (QOLS) questionnaire at baseline. The QOLS is a 16-item questionnaire and consists of 7 different subscales. The total score is calculated as the sum of the 16 items each ranged from 0 to 7. The final score ranges from 16 to 112 points (lower scores indicate more unfavourable conditions).
Time frame: day 1
Symptoms severity
Median of symptoms severity by the Numerical Rating Scale (NRS) at baseline. The NRS is a scale that assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable".
Time frame: day 1
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