UNRAVEL: The Role of Intestinal and Vaginal Microbiota, Estrogenic Activity, Metabolic Profile & Nutritional Status in Endometriosis

Sponsor

Universidade Nova de Lisboa (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05788952

Collaborator

Academia CUF (Other)

Enrollment

Location

Anticipated Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Endometriosis

Study Design

Study Type:

Observational

Anticipated Enrollment :

60 participants

Observational Model:

Case-Only

Time Perspective:

Cross-Sectional

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Outcome Measures

Primary Outcome Measures

Vaginal microbiome [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.
Intestinal microbiome [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.
Strogen levels [day 1]
Mean/median of total and free estrone (E1) and estradiol (E2) (ng E2-equivalents L-1) at baseline.
Fasting blood glucose [day 1]
Mean/median of fasting blood glucose levels (mg/dL) levels at baseline.
Insulin [day 1]
Mean/median of insulin (μU/mL) levels at baseline.
Total cholesterol [day 1]
Mean/median of total cholesterol (mg/dL) levels at baseline.
HDL cholesterol [day 1]
Mean/median of high-density lipoprotein (HDL) cholesterol (mg/dL) levels at baseline.
LDL cholesterol [day 1]
Mean/median of low-density lipoprotein (LDL) cholesterol (mg/dL) levels at baseline.
25-hydroxy vitamin D [day 1]
Mean/median of 25-hydroxy vitamin D (ng/mL) levels at baseline.
Ascorbic acid [day 1]
Mean/median of ascorbic acid (umol/L) levels at baseline.
Alpha (α)-tocopherol [day 1]
Mean/median of α-tocopherol (ug/mL) levels at baseline.
Omega-3 index [day 1]
Mean/median of omega-3 index (uL) levels at baseline.

Secondary Outcome Measures

Quality of life questionnaire [day 1]
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).
Symptoms severity [day 1]
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".