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Could ozone up the backside save Kids' brains?

NCT ID NCT07153627

Disease control Sponsor: Al-Azhar University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests whether giving ozone gas through the rectum can help protect the brain in children who have suffered a brain injury. 120 children aged 1 month to 18 years will either receive up to 80 rectal ozone sessions plus standard rehab, or rehab alone. The main goal is to see if it reduces muscle stiffness and brain inflammation.

What this could mean

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

Active substance
ozone gas
What this could lead to
If it works, this could offer a new way to reduce brain damage and improve recovery in children after a brain injury.
What could go wrong
This is an early-stage trial with no phase, and the treatment is unusual (rectal ozone). It may not prove effective, and side effects are possible.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 120 people

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

Started

May 2025

Expected to finish

Oct 2025

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.

Ages

1 month to 18 years

Sex

Anyone

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: * Age from 1 month to 18 years. * Both sexes. * Children admitted to the pediatric intensive care unit (PICU) with acquired neurological insult. * Children with neurological sequelae * Children who are exposed to acquired brain injury, e.g., traumatic brain injury, cardiac arrest, intracranial hemorrhage, central nervous system infections, stroke, tumor, or hypoxia, with neurological sequelae diagnosed by neurological examination and magnetic resonance imaging (MRI), to detect that disorder early. Exclusion Criteria: * Patients with no degree of disability or sequelae. * Patients not fit for Rectal ozone therapy. * Patients with active epilepsy and recurrent seizures. * Children with a positive family history of degenerative brain insults. * Children with behavioral problems.

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Conditions

The condition(s) this trial relates to.

brain injury central nervous system disorder injury

As listed by the trial registrant

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

Children CNS INSULT Neuroprotector Rectal ozone

How to take part

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

  1. The places running it

    1 site. 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

  • Al-Azhar University

    RECRUITING

    Cairo, 11651, Egypt

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