EndometriosisENDOBIOMENCT07576361
Impact of Microbiome in Endometriosis Development
An observational study of Endometriosis, run by Centre Hospitalier Universitaire de la Guadeloupe at 1 site in Guadeloupe.
Trial summary
Endometriosis is a chronic disease, of which the pathophysiology is still unknown. Several theories exist, the one of menstrual blood flow has been retained until now but does not fully explain it. The main symptoms are dysmenorrhea, dyspareunia and infertility. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometriosis
- How many people
- 48 participants
- Where
- 1 siteGuadeloupe
- Study dates
- 25 Nov 2020to 17 Nov 2021
- 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 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: women aged 18-50 years old
Who may be able to join
- For cases :
- aged 18-50 years old With confirmed or highly suspected endometriosis Affiliated to a social security system For controls: -aged 18-50 years old No confirmed or highly suspected Affiliated to a social security system
Who cannot join
- Minors; Pregnant women; Protected persons, or persons placed under the protection of justice; Refusal to participate
Trial locations and contacts
1 site in 1 country.
Guadeloupe1 site
Centre Hospitalier Universitaire de la Guadeloupe
Les Abymes, Guadeloupe, 97159
About this study
Endometriosis is a chronic disease, of which the pathophysiology is still unknown. Several theories exist, the one of menstrual blood flow has been retained until now but does not fully explain it. The main symptoms are dysmenorrhea, dyspareunia and infertility. The aim of this study is to evaluate the impact of c.albicans colonization of vaginal microbioma in development of endometriosis
Read the detailed description
Endometriosis is a chronic disease and its pathophysiology is still unknown. Several theories exist, the one of menstrual blood flow has been retained until now but does not fully explain it. The main symptoms are dysmenorrhea, dyspareunia and infertility. There is a large number of women with endometriosis without clinical manifestations, as well as those who suffer from it with an impact on their personal and professional lives. The estimation of prevalence is complicated since medical imagery is not conclusive in all cases and the gold-standard of diagnosis remains laparoscopy. The estimated overall prevalence is 10%. There is the notion that prevalence is higher in the Caribbean population. Recent studies have demonstrated the essential role of immunological factors and angiogenesis in the pathogenesis of endometriosis. Thus it has been shown the impact of pro-inflammatory cytokines (TNF-a, MCP-1, IL-6 IL 8) in the development and survival of endometriotic cells. The impact of the microbiome in the occurrence of certain pathologies (cancers...) and in the promotion of the carrying of infections (high risk HPV) is known. Candida albicans is a fungus widely present in normal human microbiome but its hyphae have a virulent potential that intensify the production of inflammatory cytokines via the MAPK/MKP1 /C-Fos regulatory route. This could cause endometriosis depending on the immune status of the host (pro-inflammatory context). We also speak of the "inflammasome" induced by C. albicans causing a local inflammatory reaction leading to a cascade of inflammation and the development of endometriosis The essential role of immunological factors and angiogenesis in the pathogenesis of endometriosis has been demonstrated with the impact of pro-inflammatory cytokines (TNF-a, MCP-1, IL-6 IL 8) on the development and survival of endometriotic cells. The interaction between the host genome and its microbiome is known. Candida albicans is a fungus widely present in normal human microbiome but its hyphae have a virulent potential that intensify the production of inflammatory cytokines via the MAPK/MKP1/C-Fos regulatory route. This is supposed to cause endometriosis depending on the immune status of the host (pro-inflammatory context). We also speak of the "inflammasome" induced by C. albicans causing a local inflammatory reaction leading to a cascade of inflammation and the development of endometriosis. The study will be proposed to patients during their gynecological consultation at the University Hospital of Guadeloupe. The participation to the study includes a questionnaire with epidemiological and medical data and a biospecimen collection containing a vaginal and oral swab and a saliva sample.
- Conditions
- Endometriosis
- Keywords
- C.Albicans, dysbiosis, endometriosis, inflammation
- Medical subject headings
- Endometriosis, Dysbiosis, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| case | Patient with confirmed or highly suspected endometriosis | |
| Control | No confirmed or highly suspected endometriosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
vaginal dysbiosis with C. albicans
comparison of percentages between the two groups
Measured: At inclusion
Secondary outcomes (4)
correlation between vaginal dysbioses and the presence of Candida hyphae
presence or absence of the HWP1 gene
Measured: At inclusion
impact of endometriosis on HPVhr carrying
Carriage of high-risk HPV (hrHPV) defined by the presence of one or more genotypes identified using the Innolipa® detection kit
Measured: At inclusion
inflammatory biological markers involved in the endometriotic process
"Expression of matrix metalloproteinases (MMPs)
Measured: At inclusion
inflammatory biological markers involved in the endometriotic process
Expression levels of cytokines
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2026
- Study start25 Nov 2020
- Primary completion17 Nov 2021
- Study completion17 Nov 2021
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-control
- Time perspective
- Prospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Guadeloupe
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- GÜLEN AYHAN, Doctor, Principal investigator, CHU de la Guadeloupe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07576361
- Sponsor's protocol ID
- PAP_RI2_2019/04
- Acronym
- ENDOBIOME
- Status last verified
- May 2026
- First submitted
- 4 May 2026
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Microbiome in Endometriosis Development
- ClinicalTrials.gov ID
- NCT07576361
- Acronym / sponsor ID
- ENDOBIOME / PAP_RI2_2019/04
- Conditions
- Endometriosis
- Keywords
- C.Albicans, dysbiosis, endometriosis, inflammation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de la GuadeloupeUniversity, hospital or other
- Study start
- 25 Nov 2020 (actual)
- Primary completion
- 17 Nov 2021 (actual)
- Study completion
- 17 Nov 2021 (actual)
- First posted
- 8 May 2026 (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 is a chronic disease, of which the pathophysiology is still unknown. Several theories exist, the one of menstrual blood flow has been retained until now but does not fully explain it. The main symptoms are dysmenorrhea, dyspareunia and infertility. The aim of this study is to evaluate the impact of c.albicans colonization of vaginal microbioma in development of endometriosis
Detailed description
Endometriosis is a chronic disease and its pathophysiology is still unknown. Several theories exist, the one of menstrual blood flow has been retained until now but does not fully explain it. The main symptoms are dysmenorrhea, dyspareunia and infertility. There is a large number of women with endometriosis without clinical manifestations, as well as those who suffer from it with an impact on their personal and professional lives. The estimation of prevalence is complicated since medical imagery is not conclusive in all cases and the gold-standard of diagnosis remains laparoscopy. The estimated overall prevalence is 10%. There is the notion that prevalence is higher in the Caribbean population. Recent studies have demonstrated the essential role of immunological factors and angiogenesis in the pathogenesis of endometriosis. Thus it has been shown the impact of pro-inflammatory cytokines (TNF-a, MCP-1, IL-6 IL 8) in the development and survival of endometriotic cells. The impact of the microbiome in the occurrence of certain pathologies (cancers...) and in the promotion of the carrying of infections (high risk HPV) is known. Candida albicans is a fungus widely present in normal human microbiome but its hyphae have a virulent potential that intensify the production of inflammatory cytokines via the MAPK/MKP1 /C-Fos regulatory route. This could cause endometriosis depending on the immune status of the host (pro-inflammatory context). We also speak of the "inflammasome" induced by C. albicans causing a local inflammatory reaction leading to a cascade of inflammation and the development of endometriosis The essential role of immunological factors and angiogenesis in the pathogenesis of endometriosis has been demonstrated with the impact of pro-inflammatory cytokines (TNF-a, MCP-1, IL-6 IL 8) on the development and survival of endometriotic cells. The interaction between the host genome and its microbiome is known. Candida albicans is a fungus widely present in normal human microbiome but its hyphae have a virulent potential that intensify the production of inflammatory cytokines via the MAPK/MKP1/C-Fos regulatory route. This is supposed to cause endometriosis depending on the immune status of the host (pro-inflammatory context). We also speak of the "inflammasome" induced by C. albicans causing a local inflammatory reaction leading to a cascade of inflammation and the development of endometriosis. The study will be proposed to patients during their gynecological consultation at the University Hospital of Guadeloupe. The participation to the study includes a questionnaire with epidemiological and medical data and a biospecimen collection containing a vaginal and oral swab and a saliva sample.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| case | – | –Patient with confirmed or highly suspected endometriosis |
| Control | – | –No confirmed or highly suspected endometriosis |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- women aged 18-50 years old
Key inclusion criteria (2 listed)
- aged 18-50 years old With confirmed or highly suspected endometriosis Affiliated to a social security system For controls: -aged 18-50 years old No confirmed or highly suspected Affiliated to a social security system
Key exclusion criteria (1 listed)
- Minors; Pregnant women; Protected persons, or persons placed under the protection of justice; Refusal to participate
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 dysbiosis with C. albicans
Time frame: At inclusion
comparison of percentages between the two groups
4 secondary outcomes
correlation between vaginal dysbioses and the presence of Candida hyphae
Time frame: At inclusion
impact of endometriosis on HPVhr carrying
Time frame: At inclusion
inflammatory biological markers involved in the endometriotic process
Time frame: At inclusion
inflammatory biological markers involved in the endometriotic process
Time frame: At inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: No
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Impact of a Diagnosis or Lack of a Diagnosis of Endometriosis Via a Saliva Test on Pain Catastrophizing, Quality of Life, Symptoms of Anxiety and Depression, and Treatment Adherence
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PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
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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.
GÜLEN AYHAN, Doctor principal investigator
CHU de la Guadeloupe
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 Centre Hospitalier Universitaire de la Guadeloupe at 1 site in Guadeloupe.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 8 May 2026. 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 Guadeloupe. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
vaginal dysbiosis with C. albicans (time frame: At inclusion). 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 8 May 2026.