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

Endometriosis Clinical Trial

— UNRAVEL  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05788952
• Other study ID #: UNRAVEL
• Status: Not yet recruiting
• Start date: June 1, 2023
• Est. completion date: December 1, 2024

Study information

• Verified date: March 2023
• Source: Universidade Nova de Lisboa
• Contact: Diana Teixeira, PhD
• Phone: +351218803000
• Email: diana.teixeira[@]nms.unl.pt
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Endometriosis

Locations

Country	Name	City	State
Portugal	NOVA Medical School|Faculdade de Ciências Médicas, Universidade NOVA de Lisboa	Lisboa

Sponsors (2)

Lead Sponsor	Collaborator
Universidade Nova de Lisboa	Academia CUF

Country where clinical trial is conducted

Portugal, 

Outcome

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