Innate Immunity, MIcrobiota and Inovative Treatments in Endometriosis

Launched by UNIVERSITY HOSPITAL, GRENOBLE · Jul 11, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how the immune system and gut bacteria might affect endometriosis, a condition where tissue similar to the lining of the uterus grows outside the uterus, causing pain and other symptoms. Researchers want to better understand the role of certain immune cells and how the balance of bacteria in the gut might influence the disease. The goal is to find new markers in the immune system that could help predict how endometriosis develops and responds to treatment, and to explore new treatments that help reduce inflammation in the body.

Women aged 18 to 42 who are having surgery for endometriosis or other non-cancerous gynecological conditions may be eligible. To join, women with endometriosis must have confirmed disease and be stopping hormonal treatments before surgery. Women without endometriosis will serve as a comparison group. Participants will provide tissue samples during surgery, blood and stool samples, and will have a health check at the start and, for those with endometriosis, again after one year. The study aims to follow women with endometriosis for a year to see how their immune system and gut bacteria change over time and relate to their symptoms. This research could help develop better, more targeted treatments for endometriosis in the future.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Women aged 18-42 years.
• • Surgery scheduled during the luteal phase.
• • Written informed consent provided.
• Additional inclusion criteria for the "endometriosis" group:
• • Women with confirmed endometriosis and a surgical indication (due to persistent symptoms despite medical treatment and/or risk of organ damage).
• • Hormonal therapy discontinued at least one month prior to surgery.
• • Absence of isolated ovarian endometrioma.
• Control group inclusion criteria:
• • - Women requiring benign gynecological surgery with no clinical or intraoperative evidence of endometriosis.
• No inclusion criteria (both groups):
• • 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),
• • Use of antibiotics within the month prior to surgery,
• • Recent infection (\<2 weeks),
• • Ongoing treatment with biologics or immunosuppressants,
• • Contraindication to surgery due to general condition or comorbidities,
• • Hormonal therapy within the month prior to surgery,
• • Abdominopelvic surgery involving peritoneal breach within the previous 6 months,
• • Pregnancy or breastfeeding,
• • Participation in another clinical study (RIPH 1 or 2).
• Exclusion Criteria:
• • Intraoperative impossibility to perform surgery due to local conditions with an unfavorable benefit-risk balance for the patient.
• • Discovery of endometriosis during surgery in the control group.
• • Use of biologics or immunosuppressants within the first year after inclusion in the endometriosis group.
• • Antibiotic use in the month preceding the second stool sample (endometriosis group).