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

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.

Conditions

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

Sponsors & Collaborators

• Dr. Negrin University Hospital

  collaborator OTHER

• Complejo Hospitalario Universitario Insular Materno Infantil (CHUIMI)

  collaborator UNKNOWN

• Fundacion Canaria Instituto de Investigacion Sanitaria de Canarias

  collaborator OTHER

• Instituto Universitario de Enfermedades Tropicales y Salud Pública de Canarias, Universidad de La Laguna

  collaborator UNKNOWN

• CIBER (Infectious diseases)

  collaborator UNKNOWN

• Bernardino Clavo, MD, PhD

  lead OTHER

Principal Investigators

• Bernardino Clavo, MD, PhD · Hospital Universitario de Gran Canaria Dr. Negrín, (FIISC), Las Palmas, Spain

• Jacob Lorenzo-Morales, Prof · Instituto Universitario de Enfermedades Tropicales y Salud Publica de Canarias, Universidad La Laguna

• Francisco Rodríguez-Esparragón, BSc, PhD · Hospital Universitario de Gran Canaria Dr. Negrín, (FIISC), Las Palmas, Spain

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-01-15

Primary Completion

2028-01-15

Completion

2028-03-31

Countries

• Spain

Study Locations