EndometriosisUNRAVELNCT05788952
The Role of Intestinal and Vaginal Microbiota, Estrogenic Activity, Metabolic Profile & Nutritional Status in Endometriosis
An observational study of Endometriosis, run by Universidade Nova de Lisboa at 1 site in Portugal.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometriosis
- How many people
- 60 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Jun 2023to 1 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Any premenopausal woman diagnosed with endometriosis under an outpatient gynaecology appointment at one of the recruitment locations.
Who may be able to join
- Premenopause;
- Diagnose of endometriosis by clinical and/or imaging criteria (associated adenomyosis is accepted);
- BMI between 18.5 and 30.0 kg/m2
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Portugal1 site
NOVA Medical School|Faculdade de Ciências Médicas, Universidade NOVA de Lisboa
Lisbon, 1169-056
Diana Teixeira, PhD
About this study
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
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
- Medical subject headings
- Endometriosis
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: day 1
Strogen levels
Mean/median of total and free estrone (E1) and estradiol (E2) (ng E2-equivalents L-1) at baseline.
Measured: day 1
Fasting blood glucose
Mean/median of fasting blood glucose levels (mg/dL) levels at baseline.
Measured: day 1
Insulin
Mean/median of insulin (μU/mL) levels at baseline.
Measured: day 1
Total cholesterol
Mean/median of total cholesterol (mg/dL) levels at baseline.
Measured: day 1
HDL cholesterol
Mean/median of high-density lipoprotein (HDL) cholesterol (mg/dL) levels at baseline.
Measured: day 1
LDL cholesterol
Mean/median of low-density lipoprotein (LDL) cholesterol (mg/dL) levels at baseline.
Measured: day 1
25-hydroxy vitamin D
Mean/median of 25-hydroxy vitamin D (ng/mL) levels at baseline.
Measured: day 1
Ascorbic acid
Mean/median of ascorbic acid (umol/L) levels at baseline.
Measured: day 1
Alpha (α)-tocopherol
Mean/median of α-tocopherol (ug/mL) levels at baseline.
Measured: day 1
Omega-3 index
Mean/median of omega-3 index (uL) levels at baseline.
Measured: day 1
Secondary outcomes (2)
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).
Measured: 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".
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2023
- Study start1 Jun 2023 (estimated)
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Nova de Lisboa
- Sponsor type
- University, hospital or other
- Collaborators
- Academia CUF
- Responsible party
- Sponsor
- Investigators
- Diana Teixeira, PhD, Principal investigator, NOVA Medical School | Faculdade de Ciências Médicas, Universidade Nova de Lisboa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05788952
- Sponsor's protocol ID
- UNRAVEL
- Acronym
- UNRAVEL
- Status last verified
- Mar 2023
- First submitted
- 15 Mar 2023
- Last updated
- 29 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05788952
- Acronym / sponsor ID
- UNRAVEL / UNRAVEL
- Conditions
- Endometriosis
- Keywords
- Endometriosis, Gut microbiota, Vaginal microbiota, Estrogenic activity, Xenoestrogens, Metabolic biomarkers, Nutritional status
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universidade Nova de LisboaUniversity, hospital or other
- Collaborators
- Academia CUF
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 29 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any premenopausal woman diagnosed with endometriosis under an outpatient gynaecology appointment at one of the recruitment locations.
Key inclusion criteria (3 listed)
- Premenopause;
- Diagnose of endometriosis by clinical and/or imaging criteria (associated adenomyosis is accepted);
- BMI between 18.5 and 30.0 kg/m2
Key exclusion criteria (8 listed)
- Postmenopause;
- Vegetarian diet;
- Pregnancy or breastfeeding;
- Continuous hormonal therapy for endometriosis;
- Laparoscopic surgery for endometriosis purpose;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Vaginal microbiome
Time frame: 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.
Intestinal microbiome
Time frame: 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.
Strogen levels
Time frame: day 1
Mean/median of total and free estrone (E1) and estradiol (E2) (ng E2-equivalents L-1) at baseline.
Fasting blood glucose
Time frame: day 1
Mean/median of fasting blood glucose levels (mg/dL) levels at baseline.
Insulin
Time frame: day 1
Mean/median of insulin (μU/mL) levels at baseline.
Total cholesterol
Time frame: day 1
Mean/median of total cholesterol (mg/dL) levels at baseline.
HDL cholesterol
Time frame: day 1
Mean/median of high-density lipoprotein (HDL) cholesterol (mg/dL) levels at baseline.
LDL cholesterol
Time frame: day 1
Mean/median of low-density lipoprotein (LDL) cholesterol (mg/dL) levels at baseline.
25-hydroxy vitamin D
Time frame: day 1
Mean/median of 25-hydroxy vitamin D (ng/mL) levels at baseline.
Ascorbic acid
Time frame: day 1
Mean/median of ascorbic acid (umol/L) levels at baseline.
Alpha (α)-tocopherol
Time frame: day 1
Mean/median of α-tocopherol (ug/mL) levels at baseline.
Omega-3 index
Time frame: day 1
Mean/median of omega-3 index (uL) levels at baseline.
2 secondary outcomes
Quality of life questionnaire
Time frame: day 1
Symptoms severity
Time frame: day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diana Teixeira, PhD principal investigator
NOVA Medical School | Faculdade de Ciências Médicas, Universidade Nova de Lisboa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis, run by Universidade Nova de Lisboa at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Diana Teixeira, PhD (+351218803000, diana.teixeira@nms.unl.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaginal microbiome (time frame: day 1). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2023; AzTrials last refreshed its copy on 8 Nov 2026.