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NCT05824819Recruiting

Endometriosis and Peritoneal Dysbiosis

"Is the Reduced Quality of Life of Women With Endometriosis the Result of Peritoneal Dysbiosis?"

Source: ClinicalTrials.gov · Last updated 15 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

Endometriosis is a complex clinical syndrome that impairs many aspects of a woman's life, characterized by a chronic estrogen-dependent inflammatory process, mainly affecting the pelvic organs, with ectopic presence of tissue analogous to the uterine mucosa (endometrium). Despite intensive research in the field of etiopathogenesis, its cause has not yet been determined, and treatment remains symptomatic. Endometriosis causes two main complications, i.e. pelvic pain syndrome and infertility. In recent years, thanks to the analysis of the human microbiome, it has become possible to deepen the knowledge of the physiological and pathological interactions between microorganisms inhabiting various body areas and the host. Bacteria may enter the peritoneal cavity in the mechanism of retrograde menstruation and translocate from the intestines, and then promote the development of local and systemic inflammation, leading to the symptoms of endometriosis. The study is to determine whether the presence of a specific intestinal, peritoneal and uterine microbiome correlates with endometriosis stage and whether its presence predisposes to increased pain or infertility. Concordance or divergence of bacterial populations inhabiting the peritoneal and uterine cavities could have clinical implications, i.e. the possibility of empirical antibiotic therapy in patients undergoing only endometrial aspiration biopsy and not opting for surgical treatment.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
100 (estimated)
First submitted
22 Mar 2023
Start date
1 May 2023
Primary completion date
30 Dec 2025
Lead sponsor
Jagiellonian University
NCT number
NCT05824819

What you commit to

  • Study type: Interventional
  • Planned participants: 100
  • From 1 May 2023 to the primary completion date, 30 Dec 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study design.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • abdominal surgeries performed within 6 months prior hospitalisation
  • antibiotic therapy and use of probiotics within 3 months before surgery

Other illness

  • active infection of the genital tract
  • inflammatory bowel disease

Who the study is looking for

  • age 18-45 years
  • indications for surgical treatment of endometriosis by laparoscopy and/or indications for invasive diagnostics by laparoscopy due to idiopathic infertility.

Age in the registry: 18 years to 45 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Jagiellonian University Medical College, Department of Gynecology and Obstetrics
Coordinator of this site? Confirm its status
KrakowPolandRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.