Endometriosis and Peritoneal Dysbiosis

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorJagiellonian University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

age 18-45 years

indications for surgical treatment of endometriosis by laparoscopy and/or indications for invasive diagnostics by laparoscopy due to idiopathic infertility.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: EndometriosisActive comparator 1 intervention
Group B: Idiopathic infertilityActive comparator 1 intervention

Trial outcomes

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

Time frame
up to 6 months

Secondary outcomes

1

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

Correlation between the percentage composition of the local bacterial population (by phyla and genera) and the ASRM endometriosis stage

Time frame
up to 6 months
2

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

Correlation between the percentage composition of the uterine bacterial population (by phyla and genera) and the percentage composition of the intestinal and peritoneal microbiome (by phyla and genera)

Time frame
up to 6 moths
3

Relation of intestinal, peritoneal and uterine microbiome and symptoms

Correlation between the percentage composition of local microbiomes (by phyla and genera) and the severity of pain symptoms on the Numeric Rating Scale (NRS from 0 - no pain to 10 - maximum pain) and the duration of infertility (in years)

Time frame
up to 6 moths
4

Composition of intestinal, peritoneal and uterineand quality of life

Correlation between the percentage composition of local microbiomes (by phyla and genera) and the percentage result of the SF-36 questionnaire evaluating of 8 area of life on a scale from 0% - the worst quality to 100% - the best quality

Time frame
up to 6 moths

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.