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

Not yet recruiting

• Conditions: Endometriosis

• Registration Number: NCT05788952
• Lead Sponsor: Universidade Nova de Lisboa

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-03
• Study First Submitted: 2023-03-15
• Study First Submitted QC: 2023-03-15
• Last Update Submitted: 2023-03-15
• Study First Posted: 2023-03-29
• Last Update Posted: 2023-03-29
• Study Start: 2023-06-01
• Primary Completion: 2024-06-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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".

Trial Locations

Locations (1)

NOVA Medical School|Faculdade de Ciências Médicas, Universidade NOVA de Lisboa; 🇵🇹 Lisboa, Portugal