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NCT07259681: MicrOGineTox
Gut Microbiome in Gynecological Cancer Patients With Pelvic Toxicity: Controls Versus Ozone Treatment. (MicrOzoGineTox)
trial in Pelvic Toxicity in 38 participants. Not yet recruiting.
15 January 2028
Quick facts
| Lead sponsor | Bernardino Clavo, MD, PhD |
|---|---|
| Status | Not yet recruiting |
| Study type | OBSERVATIONAL |
| Enrollment | 38 |
| Start date | 15 January 2026 |
| Primary completion | 15 January 2028 |
| Estimated completion | 31 March 2028 |
| Sites | 2 locations across Spain |
Conditions studied
- Pelvic Toxicity — all drugs for Pelvic Toxicity →
- Radiation Toxicity — all drugs for Radiation Toxicity →
- Chemotherapy Toxicity — all drugs for Chemotherapy Toxicity →
- Gynecological Tumors — all drugs for Gynecological Tumors →
Sponsor
Bernardino Clavo, MD, PhD — full company profile →
Who can join
18 and older, female only, with Pelvic Toxicity or Radiation Toxicity. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own 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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07259681
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Bernardino Clavo, MD, PhD trials
Trials by the same sponsor.
- NCT07325851 — Patients Referred to the Chronic Pain Unit for Palliative Treatment With Ozone Therapy Between 2026 and 2029. · not yet recruiting
- NCT06816095 — Gene and Molecular Pathways of Ozone Treatment Response in Gynecological Tumor Patients With Chronic Pelvic Pain Seconda · recruiting
- NCT06799351 — Gut Microbiome Profiles in Patients with Chemotherapy-induced Neuropathy in the RCT OzoParQT (NCT06706544). · Phase 2, PHASE3 · recruiting
- NCT06706544 — Ozone Treatment in Paresthesia (Numbness, Tingling) Secondary to Chemotherapy-induced Peripheral Neuropathy · Phase 2, PHASE3 · recruiting
- NCT05417737 — Patients Referred to the Chronic Pain Unit for Palliative Treatment With Ozone Therapy Between 2022 and 2025 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07259681 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Bernardino Clavo, MD, PhD
- Last refreshed: 22 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07259681.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing