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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorBernardino Clavo, MD, PhD

About this trial

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.

Eligibility criteria

Qualifiers

Adult women (>=18 years).

Diagnosed with gynecological tumors (any location and stage).

Previously treated with radiotherapy and/or chemotherapy.

Must accept and sign the specific informed consent for this study.

Disqualifiers

Not meeting all inclusion criteria.

Presence of active inflammatory bowel disease (e.g., Crohn's Disease, Ulcerative Colitis) or a history of major gastrointestinal resection (excluding appendectomy) that could significantly alter gut anatomy and microbiota.

Any uncontrolled intercurrent illness or psychiatric condition that, in the investigator's opinion, would limit compliance with study requirements or interfere with the interpretation of results.

Unwillingness or inability to provide written informed consent for study participation.

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

38 Participants
are grouped into 2 trial groups

Sponsors and collaborators

Bernardino Clavo, MD, PhD

Lead sponsor

Dr. Negrin University Hospital

Sponsor institution

Dr. Negrin University Hospital

Collaborator

Complejo Hospitalario Universitario Insular Materno Infantil (CHUIMI)

Collaborator

Fundación Canaria Instituto de Investigación Sanitaria de Canarias

Collaborator

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

Collaborator

Centers for International Business Education and Research

Collaborator