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

NCT05788952 | Unknown

• 1 other identifier: UNRAVEL
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometriosis

Keywords

Endometriosis; Gut microbiota; Vaginal microbiota; Estrogenic activity; Xenoestrogens; Metabolic biomarkers; Nutritional status

Outcome Measures

Primary Outcomes (12)

• 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 Outcomes (2)

• Quality of life questionnaire

  day 1

• Symptoms severity

  day 1

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Premenopause;
• Diagnose of endometriosis by clinical and/or imaging criteria (associated adenomyosis is accepted);
• BMI between 18.5 and 30.0 kg/m2

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Nova de Lisboa: lead
• Academia CUF: collaborator

Study Sites (1)

NOVA Medical School|Faculdade de Ciências Médicas, Universidade NOVA de Lisboa

Lisbon, 1169-056, Portugal

Location

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Diana Teixeira, PhD

  NOVA Medical School | Faculdade de Ciências Médicas, Universidade Nova de Lisboa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Diana Teixeira, PhD

CONTACT

+351218803000; diana.teixeira@nms.unl.pt

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2023
• First Posted: March 29, 2023
• Study Start: June 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 29, 2023

Record last verified: 2023-03

Locations

PT (1)