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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-01

Study Completion Date

2024-12-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Endometriosis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No