Clinical trial NCT05788952: The Role of Intestinal and Vaginal Microbiota, Estrogenic Activity, Metabolic Profile & Nutritional Status in Endometriosis
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Endometriosis
Keywords: Endometriosis
Gut microbiota
Vaginal microbiota
Estrogenic activity
Xenoestrogens
Metabolic biomarkers
Nutritional status
Lead sponsor: Universidade Nova de Lisboa
Sponsor class: OTHER
Collaborators: name: Academia CUF
First posted: 2023-03-29
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any premenopausal woman diagnosed with endometriosis under an outpatient gynaecology appointment at one of the recruitment locations.

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.


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.

Primary outcomes:
measure: Vaginal microbiome
timeFrame: day 1
measure: Intestinal microbiome
timeFrame: day 1
measure: Strogen levels
timeFrame: day 1
measure: Fasting blood glucose
timeFrame: day 1
measure: Insulin
timeFrame: day 1
measure: Total cholesterol
timeFrame: day 1
measure: HDL cholesterol
timeFrame: day 1
measure: LDL cholesterol
timeFrame: day 1
measure: 25-hydroxy vitamin D
timeFrame: day 1
measure: Ascorbic acid
timeFrame: day 1
measure: Alpha (α)-tocopherol
timeFrame: day 1
measure: Omega-3 index
timeFrame: day 1
Secondary outcomes:
measure: Quality of life questionnaire
timeFrame: day 1
measure: Symptoms severity
timeFrame: day 1
Other outcomes:
Locations:
city: Lisboa
country: Portugal
facility: NOVA Medical School|Faculdade de Ciências Médicas, Universidade NOVA de Lisboa
Study officials:
affiliation: NOVA Medical School | Faculdade de Ciências Médicas, Universidade Nova de Lisboa
name: Diana Teixeira, PhD
role: PRINCIPAL_INVESTIGATOR
References: