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CompletedNCT07576361ENDOBIOMEUpdated May 8, 2026

Impact of Microbiome in Endometriosis Development

An observational study in Endometriosis, sponsored by Centre Hospitalier Universitaire de la Guadeloupe. Completed at 1 site in Guadeloupe. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-08.

Sponsored by Centre Hospitalier Universitaire de la Guadeloupe · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
48
Ages
18 Years to 50 Years
Sex
Female
01

Study 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. 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.

02

Conditions studied

  • Endometriosis

Keywords

  • C.Albicans
  • dysbiosis
  • endometriosis
  • inflammation
03

In context

Endometriosis

920 studies on the registry are indexed under Endometriosis; 266 are open to participants now.

This study's enrollment of 48 is below the median of 135 across 349 observational studies indexed under Endometriosis.

Browse Endometriosis studies →

Lead sponsor

Centre Hospitalier Universitaire de la Guadeloupe is the lead sponsor of 50 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

women aged 18-50 years old

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

Minors; Pregnant women; Protected persons, or persons placed under the protection of justice; Refusal to participate

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
48 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • case

    Patient with confirmed or highly suspected endometriosis

  • Control

    No confirmed or highly suspected endometriosis

06

What researchers measure

Primary outcomes

  1. vaginal dysbiosis with C. albicans

    comparison of percentages between the two groups

    Time frame: At inclusion

Secondary outcomes

  1. correlation between vaginal dysbioses and the presence of Candida hyphae

    presence or absence of the HWP1 gene

    Time frame: At inclusion

  2. 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

    Time frame: At inclusion

  3. inflammatory biological markers involved in the endometriotic process

    "Expression of matrix metalloproteinases (MMPs)

    Time frame: At inclusion

  4. inflammatory biological markers involved in the endometriotic process

    Expression levels of cytokines

    Time frame: At inclusion

07

Study locations

1 site
  • Centre Hospitalier Universitaire de la Guadeloupe
    Les Abymes, Guadeloupe 97159, Guadeloupe
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07576361
Lead sponsor
Centre Hospitalier Universitaire de la Guadeloupe
Responsible party
Sponsor
First posted
May 8, 2026
Start date
Nov 25, 2020
Primary completion
Nov 17, 2021
Completion
Nov 17, 2021
Last update
May 8, 2026

Study contacts

GÜLEN AYHAN, Doctor
principal investigator · CHU de la Guadeloupe

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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