[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100502635":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":25,"centralContacts":29,"locations":37,"responsibleParty":57,"collaborators":24,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":24,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":24,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":24,"overallStatus":40,"whyStopped":24,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Jagiellonian University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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\u002F 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.",[13],"Diagnostic Test: Next Generation Sequencing (NGS)",{"label":15,"type":10,"description":16,"interventionNames":17},"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\u002F washings from the peritoneal cavity (2 ml) and collection of endometrial tissue by aspiration biopsy of the uterine cavity (1 ml) for NGS examination.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DIAGNOSTIC_TEST","Next Generation Sequencing (NGS)","Biological materials (stool, peritoneal\u002Fovarian 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.",[9,15],null,[26],{"name":27,"affiliation":5,"role":28},"Robert Jach, Prof. Ph.D.","STUDY_CHAIR",[30,35],{"name":31,"role":32,"phone":33,"phoneExt":24,"email":34},"Iwona M. Gawron, Ph.D.","CONTACT","+48 124248571","iwona.gawron@uj.edu.pl",{"name":27,"role":32,"phone":33,"phoneExt":24,"email":36},"robert.jach@uj.edu.pl",[38],{"facility":39,"status":40,"city":41,"state":24,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Jagiellonian University Medical College, Department of Gynecology and Obstetrics","RECRUITING","Krakow","31-501","Poland","PL",{"type":46,"coordinates":47},"Point",[48,49],19.93658,50.06143,{"lat":49,"lon":48},[52,54],{"name":31,"role":32,"phone":53,"phoneExt":24,"email":34},"+48 12 4248570",{"name":55,"role":32,"phone":56,"phoneExt":24,"email":36},"Robert Jach, Prof.","+48 12 4248571",{"type":58,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"PRINCIPAL_INVESTIGATOR","Iwona Magdalena Gawron","Ph.D., Principal Investigator","100502635","endometriosis-and-peritoneal-dysbiosis-100502635",false,"NCT05824819","Endometriosis and Peritoneal Dysbiosis","\"Is the Reduced Quality of Life of Women With Endometriosis the Result of Peritoneal Dysbiosis?\"","Inclusion Criteria:\n\n* age 18-45 years\n* indications for surgical treatment of endometriosis by laparoscopy and\u002For indications for invasive diagnostics by laparoscopy due to idiopathic infertility.\n\nExclusion Criteria:\n\n* abdominal surgeries performed within 6 months prior hospitalisation\n* active infection of the genital tract\n* inflammatory bowel disease\n* antibiotic therapy and use of probiotics within 3 months before surgery","FEMALE","18 Years","45 Years",{"count":72,"type":73},100,"ESTIMATED","INTERVENTIONAL",[76],"NA","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.",[9,79],"Infertility Unexplained","2025-04-13",{"date":82,"type":83},"2025-04-15","ACTUAL",{"date":85,"type":83},"2023-05-01",{"date":87,"type":73},"2025-12-30",{"name":5,"class":6},1]