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

Study acronym: MicrOGineTox
StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Recruitment opened Show 4 more changesShow less
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: details revised at 2 of 3 entries
    • Site details revised at 2 of 2 sites
    • Publications: details revised at 9 of 9 entries
  2. Study title shortened, about 4 wordsv3
  3. Re-verified, no change to tracked fieldsv2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
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
(from sponsor)		 Pelvic Toxicity, Radiation Toxicity, Chemotherapy Toxicity, Gynecological Tumors, Radiation Proctitis, Radiation Cystitis, Vaginal Mucositis, Vulvar Mucositis +2 more
Related terms Dysbiosis, Radiation Injuries
Enrollment 38 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov