Endometriosis and Peritoneal Dysbiosis

NCT05824819 | Recruiting DMC

• 1 other identifier: 1072.6120.24.2023
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Endometriosis; Infertility Unexplained

Outcome Measures

Primary Outcomes (1)

• Composition of intestinal, peritoneal and uterine microbiome in both study arms

  Percentage composition of the local bacterial population by phyla and genera

  up to 6 months

Secondary Outcomes (4)

• Relation of the composition of intestinal, peritoneal and uterine microbiome and endometriosis stage

  up to 6 months

• Relation of the uterine microbiome to the intestinal and peritoneal microbiome in women with endometriosis and idiopathic infertility

  up to 6 moths

• Relation of intestinal, peritoneal and uterine microbiome and symptoms

  up to 6 moths

• Composition of intestinal, peritoneal and uterineand quality of life

  up to 6 moths

Study Arms (2)

Endometriosis

ACTIVE COMPARATOR

Women subjected to laparoscopy due to endometriosis. Before the procedure: collection of a stool sample for NGS testing (2 ml); During the procedure: collection of fluid/ washings from the peritoneal cavity (2 ml) and fluid from the endometrial cyst (2 ml), and collection of endometrial tissue by aspiration biopsy of the uterine cavity (1 ml) for NGS examination.

Diagnostic Test: Next Generation Sequencing (NGS)

Idiopathic infertility

ACTIVE COMPARATOR

Women subjected to laparoscopy due to idiopathic infertility. Before the procedure: collection of a stool sample for NGS testing (2 ml); During the procedure: collection of fluid/ washings from the peritoneal cavity (2 ml) and collection of endometrial tissue by aspiration biopsy of the uterine cavity (1 ml) for NGS examination.

Diagnostic Test: Next Generation Sequencing (NGS)

Interventions

Next Generation Sequencing (NGS) DIAGNOSTIC_TEST

Biological materials (stool, peritoneal/ovarian cyst fluid, endometrial aspirate) will be secured and then subjected to molecular analysis using the Next Generation Sequencing (NGS) method. The stages will include: i) isolation of bacterial DNA from biological materials, ii) preparation of libraries for sequencing, including the performance of the PCR and nested-PCR methods on bacterial DNA isolates from the tested samples of biological materials, iii) purification of amplification products, indexing, validation of the concentration of amplicons, pooling and denaturation of libraries, iv) standardization and optimization of the procedure for the isolation of bacterial metagenomic DNA from biological materials from intestines, peritoneal cavity, uterine cavity and endometrial tissues, v) standardization of the nested-PCR method on bacterial DNA isolates from the tested biological materials, vi) submission of samples for sequencing.

Endometriosis; Idiopathic infertility

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• abdominal surgeries performed within 6 months prior hospitalisation
• active infection of the genital tract
• inflammatory bowel disease
• antibiotic therapy and use of probiotics within 3 months before surgery

Sponsors & Collaborators

• Jagiellonian University: lead

Study Sites (1)

Jagiellonian University Medical College, Department of Gynecology and Obstetrics

Krakow, 31-501, Poland

RECRUITING

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

• Robert Jach, Prof. Ph.D.

  Jagiellonian University

  STUDY CHAIR

Central Study Contacts

Iwona M. Gawron, Ph.D.

CONTACT

+48 124248571; iwona.gawron@uj.edu.pl

Robert Jach, Prof. Ph.D.

CONTACT

+48 124248571; robert.jach@uj.edu.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D., Principal Investigator

Model Details: Prospective tertiary single-centre cohort study

Study Record Dates

• First Submitted: March 22, 2023
• First Posted: April 24, 2023
• Study Start: May 1, 2023
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: April 15, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)