NCT07259681

Gut Microbiome in Gynecological Cancer Patients With Pelvic Toxicity: Controls Versus Ozone Treatment. (MicrOzoGineTox)

Intestinal Microbiome Profiles in Women With Gynecological Tumors and Pelvic Toxicity Secondary to Radiotherapy and Chemotherapy: Comparison With Controls and Effect of Rectal Ozone Treatment.

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 38 (estimated)
• Sponsor: Bernardino Clavo, MD, PhD · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Patients treated for gynecological tumors with radiotherapy (RT) and/or chemotherapy (CT) frequently develop pelvic toxicity (TPIRQT), a condition that can become persistent, progressive, and refractory to standard treatments. This toxicity, affecting the rectum (proctitis), bladder (cystitis), and vagina (mucositis), severely deteriorates quality of life. Standard options for refractory cases are limited; at our center, rectal ozone therapy is used with high rates of symptomatic improvement (66-75%). Emerging evidence suggests a link between gut microbiota and the development of TPIRQT. However, it is unknown how rectal ozone therapy may influence the gut microbiome or if this modulation is part of its therapeutic mechanism. This prospective observational study will investigate the potential relationship between gut microbiome profiles (composition and diversity), the presence and severity of TPIRQT, and the response to rectal ozone therapy.

Detailed description

Patients treated for gynecological tumors with radiotherapy (RT) and/or chemotherapy (CT) frequently develop pelvic toxicity (TPIRQT), a condition that can become persistent, progressive, and refractory to standard treatments. This toxicity, affecting the rectum (proctitis), bladder (cystitis), and vagina (mucositis), severely deteriorates quality of life. Standard options for refractory cases are limited; at our center, rectal ozone therapy is used with high rates of symptomatic improvement (66-75%). Emerging evidence suggests a link between gut microbiota and the development of TPIRQT. However, it is unknown how rectal ozone therapy may influence the gut microbiome or if this modulation is part of its therapeutic mechanism. This prospective observational study will investigate the potential relationship between gut microbiome profiles (composition and diversity), the presence and severity of TPIRQT, and the response to rectal ozone therapy.

Conditions

• Pelvic Toxicity
• Radiation Toxicity
• Chemotherapy Toxicity
• Gynecological Tumors
• Radiation Proctitis
• Radiation Cystitis
• Vaginal Mucositis
• Vulvar Mucositis
• Quality of Life
• Dysbiosis

Timeline

• Start date: 2026-01-15
• Primary completion: 2028-01-15
• Completion: 2028-03-31
• First posted: 2025-12-02
• Last updated: 2025-12-22

Locations

2 sites across 1 country: Spain