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Could ozone therapy soothe pelvic pain by changing gut bacteria?

NCT ID NCT07259681

Knowledge-focused Sponsor: Bernardino Clavo, MD, PhD Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at 38 women who had pelvic side effects (like pain in the rectum, bladder, or vagina) after radiation or chemotherapy for gynecological cancers. Researchers will compare their gut bacteria to healthy controls and see if rectal ozone therapy changes the microbiome and eases symptoms. The goal is to understand why some women get severe, lasting side effects and how ozone might help.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
rectal ozone therapy
What this could lead to
If successful, this study could reveal how gut bacteria relate to pelvic side effects from cancer treatment and whether ozone therapy works by changing the microbiome, pointing toward better management strategies.
What could go wrong
This is a small, early observational study (38 people) that does not test a new treatment directly. It may only show associations, not cause and effect, and results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 38 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients with gynecological tumors treated with RT and/or CT with or without chronic pelvic toxicity (TPIRQT).

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria for all patients (Cases and Controls): 1. Adult women (\>=18 years). 2. Diagnosed with gynecological tumors (any location and stage). 3. Previously treated with radiotherapy and/or chemotherapy. 4. Must accept and sign the specific informed consent for this study. Additional Inclusion Criteria for inclusion in the TPIRQT Group (Cases): 5. Must present chronic TPIRQT with \>= 3 months of duration after habitual symptomatic treatment. 6. Must have a toxicity Grade of 2 (moderate symptoms, limiting instrumental ADL) or higher, according to the CTCAE v.5.0 scale. Exclusion Criteria for all patients (Cases and Controls): 1. Not meeting all inclusion criteria. 2. 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. 3. 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. 4. Unwillingness or inability to provide written informed consent for study participation.

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Conditions

The condition(s) this trial relates to.

chemotherapy-induced toxicity Dysbiosis female reproductive organ cancer female reproductive system neoplasm mucositis radiation cystitis radiation injury radiation proctitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chemotherapy toxicity Dysbiosis Gynecological tumors Pelvic toxicity Quality of life Radiation cystitis Radiation proctitis Radiation toxicity Vaginal mucositis Vulvar mucositis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hospital Universitario de Gran Canaria Dr. Negrín, (FIISC)

    Las Palmas de Gran Canaria, Las Palmas, 35019, Spain

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

    San Cristóbal de La Laguna, Tenerife, 38296, Spain

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