- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05824819
Endometriosis and Peritoneal Dysbiosis
November 16, 2023 updated by: Iwona Magdalena Gawron, Jagiellonian University
"Is the Reduced Quality of Life of Women With Endometriosis the Result of Peritoneal Dysbiosis?"
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
The main objective of the project is to analyze gut, peritoneal and uterine microbiome in women who undergo laparoscopy due to endometriosis (arm 1) or idiopathic infertility (arm 2).
Detailed objectives are: i) analysis of the correlation between the composition of the intestinal, peritoneal and uterine microbiome with the stage of endometriosis according to ASRM, ii) qualitative comparison of the intestinal and peritoneal microbiome to the uterine cavity microbiome in women with endometriosis vs. idiopathic infertility, iii) analysis of the correlation between the composition of the intestinal, peritoneal and uterine microbiome with the intensity of pain and infertility, iv) comparing the quality of life in both arms and assessing its correlation with the local microbiome.
Quality of life will be assessed in both arms using the SF-36 questionnaire, and then compared.
The SF-36 self-reported questionnaire covers eight health domains: physical functioning (10 items), bodily pain (2 items), role limitations due to physical health problems (4 items), role limitations due to personal or emotional problems (4 items), emotional well-being (5 items), social functioning (2 items), energy/fatigue (4 items), and general health perceptions (5 items).
Scores for each domain range from 0 to 100, with a higher score defining a more favorable health state.
The study group will consist of women of childbearing age, undergoing surgical treatment due to pelvic endometriosis or idiopathic infertility.
Before the surgery, a stool sample will be taken for examination of intestinal microbiome.
During scheduled laparoscopy, in addition to the planned procedure, which is the purpose of hospitalization, an endometrial aspiration biopsy will be performed and fluid from the peritoneal cavity and/or fluid from the ovarian cyst will be collected for analysis of the local microbiome.
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.
Sequencing data will be subjected to bioinformatics analysis to obtain bacterial profiles (the percentage composition of the local bacterial population by phyla and genera).
The aim is to characterize the microbiome of the intestines, peritoneal and the uterine cavity in women undergoing surgical treatment for endometriosis or invasive diagnostics for idiopathic infertility, and to compare the bacterial populations in these locations, which may also provide information on the origin of bacteria in the peritoneal cavity.
Study Type
Interventional
Enrollment (Estimated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Iwona M. Gawron, Ph.D.
- Phone Number: +48 124248571
- Email: iwona.gawron@uj.edu.pl
Study Contact Backup
- Name: Robert Jach, Prof. Ph.D.
- Phone Number: +48 124248571
- Email: robert.jach@uj.edu.pl
Study Locations
-
-
-
Kraków, Poland, 31-501
- Recruiting
- Jagiellonian University Medical College, Department of Gynecology and Obstetrics
-
Contact:
- Iwona M. Gawron, Ph.D.
- Phone Number: +48 12 4248570
- Email: iwona.gawron@uj.edu.pl
-
Contact:
- Robert Jach, Prof.
- Phone Number: +48 12 4248571
- Email: robert.jach@uj.edu.pl
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- age 18-45 years
- indications for surgical treatment of endometriosis by laparoscopy and/or indications for invasive diagnostics by laparoscopy due to idiopathic infertility.
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Endometriosis
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.
|
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.
|
Active Comparator: Idiopathic infertility
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Composition of intestinal, peritoneal and uterine microbiome in both study arms
Time Frame: up to 6 months
|
Percentage composition of the local bacterial population by phyla and genera
|
up to 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Relation of the composition of intestinal, peritoneal and uterine microbiome and endometriosis stage
Time Frame: up to 6 months
|
Correlation between the percentage composition of the local bacterial population (by phyla and genera) and the ASRM endometriosis stage
|
up to 6 months
|
Relation of the uterine microbiome to the intestinal and peritoneal microbiome in women with endometriosis and idiopathic infertility
Time Frame: up to 6 moths
|
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)
|
up to 6 moths
|
Relation of intestinal, peritoneal and uterine microbiome and symptoms
Time Frame: up to 6 moths
|
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)
|
up to 6 moths
|
Composition of intestinal, peritoneal and uterineand quality of life
Time Frame: up to 6 moths
|
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
|
up to 6 moths
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Robert Jach, Prof. Ph.D., Jagiellonian University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2023
Primary Completion (Estimated)
May 1, 2025
Study Completion (Estimated)
May 1, 2025
Study Registration Dates
First Submitted
March 22, 2023
First Submitted That Met QC Criteria
April 10, 2023
First Posted (Actual)
April 24, 2023
Study Record Updates
Last Update Posted (Estimated)
November 17, 2023
Last Update Submitted That Met QC Criteria
November 16, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1072.6120.24.2023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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