[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100598972":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":39,"centralContacts":48,"locations":58,"responsibleParty":82,"collaborators":84,"id":86,"slug":87,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":94,"sex":95,"minAge":96,"maxAge":97,"enrollmentInfo":98,"targetDuration":26,"studyType":101,"phases":102,"briefSummary":104,"conditions":105,"keywords":109,"overallStatus":115,"whyStopped":26,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":125},{"fullName":5,"class":6},"University Hospital, Grenoble","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Endometriosis group","ACTIVE_COMPARATOR","Patients in \"endometriosis group\" are aged 18-42 years and suffer symptomatic endometriosis that requires a surgery indication (due to persistent symptoms despite medical treatment and\u002For risk of organ damage). These patients generally undergo hormonal therapy, but this must be discontinued at least one month prior to surgery. The surgery is scheduled to take place during the luteal phase.\n\nPatients don't take a immunosuppressor, antibiotic or present inflammatory bowel disease, recent infection, pregnancy",[13,14,15],"Procedure: surgery (any volume) and \u002F or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines","Biological: Blood test","Biological: Stool samples",{"label":17,"type":10,"description":18,"interventionNames":19},"Control group","Patients in \"control group\" are aged 18-42 years and don't suffer endometriosis that requires a gynecological surgery indication (permanent contraception, benine surgery). The surgery is scheduled to take place during the luteal phase. Patients don't take a immunosuppressor, antibiotic or present inflammatory bowel disease, recent infection, pregnancy",[13,14,15],[21,27,32,36],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","surgery (any volume) and \u002F or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines","The surgery is performed on both arms as part of the current \u002F recommended treatment. But during this surgery, an extension of the samples is performed. In both arms, the surgeons take samples of the endometrium, peritoneum and peritoneal lavage. For patients with endometriosis, the lesion is also sampled.",[17,9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"BIOLOGICAL","Blood test","Before surgery, the patient will need a blood test at the recommendation of the anaesthetist. This allows us to see the level of oestrogen and progesterone in the blood.",[17,9],{"type":28,"name":33,"description":34,"armGroupLabels":35,"otherNames":26},"Stool samples","Before the surgery, the patient will take a stool sample.",[17,9],{"type":28,"name":33,"description":37,"armGroupLabels":38,"otherNames":26},"After 1 year's follow-up, the patient will take a stool sample.",[9],[40,44],{"name":41,"affiliation":42,"role":43},"Laurence Chaperot, PhD","Etablissement Français du Sang","STUDY_DIRECTOR",{"name":45,"affiliation":46,"role":47},"Thierry Michy, Dortor","Centre Universitaire Grenoble Alpes","PRINCIPAL_INVESTIGATOR",[49,54],{"name":50,"role":51,"phone":52,"phoneExt":26,"email":53},"Alexandre Buisson, Doctor","CONTACT","+33679825389","abuisson2@chu-grenoble.fr",{"name":55,"role":51,"phone":56,"phoneExt":26,"email":57},"Lora Pejot, ARC","+33476766561","lpejot@chu-grenoble.fr",[59],{"facility":60,"status":26,"city":61,"state":62,"zip":63,"country":64,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":71,"contacts":72},"CHUGA","Grenoble","Isère","38000","France","FR",{"type":67,"coordinates":68},"Point",[69,70],5.71479,45.17869,{"lat":70,"lon":69},[73,74,78,80],{"name":50,"role":51,"phone":52,"phoneExt":26,"email":53},{"name":75,"role":51,"phone":26,"phoneExt":76,"email":77},"Laura Chambon, Chef de projet Clinique","+33476768935","LChambon@chu-grenoble.fr",{"name":79,"role":47,"phone":26,"phoneExt":26,"email":26},"Thierry Michy, Doctor",{"name":50,"role":81,"phone":26,"phoneExt":26,"email":26},"SUB_INVESTIGATOR",{"type":83,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[85],{"name":42,"class":6},"100598972","innate-immunity-microbiota-and-inovative-treatments-in-endometriosis-100598972",false,"NCT07078435","Innate Immunity, MIcrobiota and Inovative Treatments in Endometriosis","Inflammation, Innate Immunity, MIcrobiota and Inovative Treatments in ENDOmetriosis","IMIEndo","Inclusion Criteria:\n\n* Women aged 18-42 years.\n* Surgery scheduled during the luteal phase.\n* Written informed consent provided.\n\nAdditional inclusion criteria for the \"endometriosis\" group:\n\n* Women with confirmed endometriosis and a surgical indication (due to persistent symptoms despite medical treatment and\u002For risk of organ damage).\n* Hormonal therapy discontinued at least one month prior to surgery.\n* Absence of isolated ovarian endometrioma.\n\nControl group inclusion criteria:\n\n\\- Women requiring benign gynecological surgery with no clinical or intraoperative evidence of endometriosis.\n\nNo inclusion criteria (both groups):\n\n* Presence of inflammatory bowel disease (Crohn's disease, ulcerative colitis) or other autoimmune disorders (e.g., lupus, Sjögren's syndrome, antiphospholipid syndrome, rheumatoid arthritis, spondyloarthritis),\n* Use of antibiotics within the month prior to surgery,\n* Recent infection (\\\u003C2 weeks),\n* Ongoing treatment with biologics or immunosuppressants,\n* Contraindication to surgery due to general condition or comorbidities,\n* Hormonal therapy within the month prior to surgery,\n* Abdominopelvic surgery involving peritoneal breach within the previous 6 months,\n* Pregnancy or breastfeeding,\n* Participation in another clinical study (RIPH 1 or 2).\n\nExclusion Criteria:\n\n* Intraoperative impossibility to perform surgery due to local conditions with an unfavorable benefit-risk balance for the patient.\n* Discovery of endometriosis during surgery in the control group.\n* Use of biologics or immunosuppressants within the first year after inclusion in the endometriosis group.\n* Antibiotic use in the month preceding the second stool sample (endometriosis group).",true,"FEMALE","18 Years","42 Years",{"count":99,"type":100},40,"ESTIMATED","INTERVENTIONAL",[103],"NA","Endometriosis is a chronic inflammatory, polygenic, and multifactorial disease affecting approximately 10% of women of reproductive age, corresponding to over one million women in France. Endometriosis profoundly impairs the health and quality of life of affected individuals and carries a significant socio-economic burden, making it a major public health concern. To date, the pathogenesis and prognostic factors of disease progression remain poorly understood. Despite current treatment options, which are based on hormonal therapy or surgery, resistance and recurrence are frequent, underscoring the urgent need for innovative therapeutic strategies.\n\nThe hypothesis of retrograde menstruation of endometrial cells, among other proposed theories, appears insufficient to fully explain the development of the disease. Immunological factors may be implicated. Endometriosis is characterized by the presence of endometriotic tissue outside the uterine cavity- within the peritoneal cavity or at distant sites-forming lesions that, like eutopic endometrium, contain infiltrating immune cells, with varying compositions across menstrual cycle phases. Although data remain scarce, the literature points to several key mechanisms:\n\nInflammation and innate immunity with the dendritic cells, that initiate and orchestrate immune responses, appear to be present in different proportions and exhibit altered phenotypes in endometriotic tissue compared to healthy tissue. Macrophages, essential for phagocytosis, tissue repair, and the resolution of inflammation, also show functional and phenotypic modulation. In particular, efferocytosis-their ability to clear apoptotic cells-is impaired, and an imbalance in M1\u002FM2 polarization has been described, potentially facilitating menstrual cell escape. The local microenvironment is characterized by altered cytokine and chemokine profiles. Natural Killer cells exhibit disrupted expression patterns of activating and degranulation capacity.\n\nMicrobiota: Many studies suggest a potential role for the intestinal microbiota in the initiation and\u002For promotion of endometriosis. Patients frequently exhibit gut dysbiosis, marked by reduced microbial diversity.\n\nResolution of Inflammation: Endometriosis may be associated with defective resolution of inflammation. Resolutive pharmacology involves the use of pro-resolving factors to exert a therapeutic effect by accelerating or stimulating the resolution of inflammation.\n\nThe interplay between local inflammation, the gut microbiota, and disease progression remains incompletely elucidated. A comprehensive phenotypic and functional characterization of immune cells-particularly innate immune cells (dendritic cells, macrophages, Natural Killer cells) - in parallel with microbiome profiling and clinical outcome data, may yield novel insights into disease mechanisms and support the development of pro-resolutive therapeutic strategies that may be of interest in endometriosis.\n\nStudy Design This will be a monocentric (at Grenoble University Hospital), open-label, prospective experimental study with a control arm.\n\nThe primary objective is to identify immune biomarkers associated with endometriosis.\n\nSecondary objectives include:\n\n1. Identification of immune biomarkers associated with clinical outcomes in endometriosis.\n2. Characterization of the immunogenetic KIR\u002FHLA (Killer Immunoglobulin-like Receptors \u002F Human Leukocyte Antigen) system in both study groups.\n3. Analysis of stromal cells, apoptosis, macrophage efferocytosis, and their responsiveness to pro-resolutive factors in both groups.\n4. Identification of a characteristic bacterial gut microbiota profile at diagnosis in women with endometriosis versus controls, and\u002For profiles associated with one-year clinical outcomes (favorable vs unfavorable), as well as temporal microbiota trajectories over one year in relation to clinical response.\n\nStudy Population:\n\nThe study will include women undergoing surgery for endometriosis versus control women undergoing benign gynecological surgery with no known history or intraoperative evidence of endometriosis, aged 18 to 42.\n\nStudy Procedures:\n\nWomen in the endometriosis group will undergo collection of endometriotic lesions, adjacent tissue, eutopic endometrium, and peritoneal lavage during surgery. Controls will provide biopsies of eutopic endometrium, unaffected peritoneum, and peritoneal lavage. For both groups, peripheral blood samples will be collected during routine care and stool samples obtained at baseline (Day 0). For the endometriosis group, a second stool sample will be collected at 12 months (M12).\n\nA clinical evaluation will be performed at inclusion for all participants and repeated at one year for the endometriosis group. Participation for control group subjects is limited to the day of surgery, whereas endometriosis group subjects will be followed for 12 months.",[106,107,108],"Endometriosis","Immunity","Microbiota",[110,111,112,113,114],"endometriosis","surgery","immunity","efferocytose","microbiota","NOT_YET_RECRUITING","2025-08-25",{"date":118,"type":119},"2025-09-02","ACTUAL",{"date":121,"type":100},"2025-09-09",{"date":123,"type":100},"2027-09-30",{"name":5,"class":6},1]