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

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.

NCT Number	NCT07259681
Lead Sponsor	Bernardino Clavo, MD, PhD Collaborators: Hospital Universitario de Gran Canaria Doctor Negrín, Complejo Hospitalario Universitario Insular Materno Infantil, Fundación Canaria Instituto de Investigación Sanitaria de Canarias, Instituto Universitario de Enfermedades Tropicales y Salud Pública de Canarias, Universidad de La Laguna, Centers for International Business Education and Research
Conditions	Pelvic Toxicity, Radiation Toxicity, Chemotherapy Toxicity, Gynecological Tumors, Radiation Proctitis, Radiation Cystitis, Vaginal Mucositis, Vulvar Mucositis +2 more
Enrollment	38 participants
Start Date	2026-01-15
Primary Completion	2028-01-15 (estimated)
Study Completion	2028-03-31 (estimated)
Updated on ClinicalTrials.gov	2025-12-22