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

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

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 Overview

• Status: Not yet recruiting
• Conditions: Endometriosis

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

• Study Contact: Name: Diana Teixeira, PhD; Phone Number: +351218803000; Email: diana.teixeira@nms.unl.pt

Study Locations

• Portugal
  • Lisboa, Portugal, 1169-056
    • NOVA Medical School|Faculdade de Ciências Médicas, Universidade NOVA de Lisboa
    • Contact: Diana Teixeira, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Any premenopausal woman diagnosed with endometriosis under an outpatient gynaecology appointment at one of the recruitment locations.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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".	day 1

Collaborators and Investigators

• Sponsor: Universidade Nova de Lisboa
• Collaborators: Academia CUF
• Investigators: Principal Investigator: Diana Teixeira, PhD, NOVA Medical School | Faculdade de Ciências Médicas, Universidade Nova de Lisboa

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2023
• Primary Completion (Anticipated): June 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: March 15, 2023
• First Submitted That Met QC Criteria: March 15, 2023
• First Posted (Actual): March 29, 2023

Study Record Updates

• Last Update Posted (Actual): March 29, 2023
• Last Update Submitted That Met QC Criteria: March 15, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Endometriosis; Gut microbiota; Nutritional status; Metabolic biomarkers; Vaginal microbiota; Estrogenic activity; Xenoestrogens
• Additional Relevant MeSH Terms: Endometriosis
• Other Study ID Numbers: UNRAVEL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No