Not Yet RecruitingNot Applicable

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

Spain38 participantsStarted 2026-01-15

Plain-language 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.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.
. Must present chronic TPIRQT with \>= 3 months of duration after habitual symptomatic treatment.
. Must have a toxicity Grade of 2 (moderate symptoms, limiting instrumental ADL) or higher, according to the CTCAE v.5.0 scale.

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Comparison of gut microbiome profile (composition and diversity) between TPIRQT and Control groups

Timeframe: Baseline (single time point for controls, pre-ozone for cases)

Change in gut microbiome profile (composition and diversity) in patients with TPIRQT after rectal ozone therapy.

Timeframe: Baseline (pre-ozone therapy) , 4 Months (post-ozone therapy)

Correlation of gut microbiome profile with grade of pelvic toxicity.

Timeframe: Baseline (for Control group); Baseline, 4 Months (for TPIRQT group).

Trial details

NCT IDNCT07259681

SponsorBernardino Clavo, MD, PhD

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2028-01-15

Contact for this trial

Bernardino Clavo, MD, PhD

34928449278 bernardinoclavo@gmail.com

View on ClinicalTrials.gov More Pelvic Toxicity trials