Rectal OzoneNCT07153627
Rectal Ozone as Neuroprotector Post CNS Insult in Children
A study testing Rectal ozone sessions and Conventional rehabilitation program in people with Rectal Ozone and Neuroprotector, run by Al-Azhar University at 1 site in Egypt.
Trial summary
This study aims to evaluate the efficacy of rectal ozone therapy as a neuroprotective modality in Pediatric acquired brain injury. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Rectal Ozone, Neuroprotector, CNS
- What is being tested?
- Rectal ozone sessions and Conventional rehabilitation program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2025to 1 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Al-Azhar University
Cairo, 11651
Ahmed M Asfour, Master, 00201017440223, drahmedasfour14@gmail.com
Osama A Elagami, MD
About this study
This study aims to evaluate the efficacy of rectal ozone therapy as a neuroprotective modality in Pediatric acquired brain injury.
Read the detailed description
Acquired brain injury (ABI) from primary neurologic diagnoses accounts for 20% of all pediatric critical care admissions and more than 60,000 hospital admissions annually.
Ozone (O3) gas was discovered in the 1840s, and soon after that, the scientific community began to expand past the notion that it was just another gas of the Earth's atmosphere.
- Conditions
- Rectal Ozone, Neuroprotector, CNS, Insult, Children
- Being tested
- Rectal ozone sessions, Conventional rehabilitation program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rectal ozone sessionsOther
Patients will receive 40 Rectal ozone sessions or until improvement (maximum 80 sessions), in addition to their conventional rehabilitation program.
Conventional rehabilitation programOther
Patients will receive their conventional rehabilitation program only (physiotherapy sessions three times per week for the treatment period (six months).
| Study group | Role | What they receive |
|---|---|---|
| Group I | Experimental | Patients will receive 40 Rectal ozone sessions or until improvement (maximum 80 sessions), in addition to their conventional rehabilitation program. Receives: Other: Rectal ozone sessions |
| Group 2 | Active comparator | Patients will receive their conventional rehabilitation program only (physiotherapy sessions three times per week for the treatment period (six months). Receives: Other: Conventional rehabilitation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of muscle Tone
Assessment of muscle tone (degree of spasticity) of affected child according to Modified Ashworth's Scale. Ashworth's scale is a 6-point scale, from 0 to 4, with higher scores indicating greater spasticity.
Measured: 6 months post-sessions
Secondary outcomes (4)
Incidence of reduction in neuroinflammation
Incidence of reduction in neuroinflammation will be recorded.
Measured: 6 months post-sessions
Assessment of quality of life
Assessment of quality of life including emotional well-being or social interaction will be recorded.
Measured: 6 months post-sessions
Incidence of adverse effects
Incidence of adverse effects will be recorded.
Measured: 6 months post-sessions
Measurement of age-related response variability
Age-related response variability by evaluating how different age groups respond to treatment will be recorded.
Measured: 6 months post-sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start1 May 2025
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal OzoneStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Abd ELgawad Mohamed Asfour, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07153627
- Sponsor's protocol ID
- KFSIRB200-623
- Status last verified
- Aug 2025
- First submitted
- 19 Aug 2025
- Last updated
- 4 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rectal Ozone as Neuroprotector Post CNS Insult in Children
- ClinicalTrials.gov ID
- NCT07153627
- Acronym / sponsor ID
- KFSIRB200-623
- Conditions
- Rectal Ozone, Neuroprotector, CNS, Insult, Children
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 4 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the efficacy of rectal ozone therapy as a neuroprotective modality in Pediatric acquired brain injury.
Detailed description
Acquired brain injury (ABI) from primary neurologic diagnoses accounts for 20% of all pediatric critical care admissions and more than 60,000 hospital admissions annually.
Ozone (O3) gas was discovered in the 1840s, and soon after that, the scientific community began to expand past the notion that it was just another gas of the Earth's atmosphere.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | Experimental | Other: Rectal ozone sessionsPatients will receive 40 Rectal ozone sessions or until improvement (maximum 80 sessions), in addition to their conventional rehabilitation program. |
| Group 2 | Active comparator | Other: Conventional rehabilitation programPatients will receive their conventional rehabilitation program only (physiotherapy sessions three times per week for the treatment period (six months). |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rectal ozone sessionsPatients will receive 40 Rectal ozone sessions or until improvement (maximum 80 sessions), in addition to their conventional rehabilitation program. | Other | Group I |
| Conventional rehabilitation programPatients will receive their conventional rehabilitation program only (physiotherapy sessions three times per week for the treatment period (six months). | Other | Group 2 |
Primary outcome
Assessment of muscle Tone
Time frame: 6 months post-sessions
Assessment of muscle tone (degree of spasticity) of affected child according to Modified Ashworth's Scale. Ashworth's scale is a 6-point scale, from 0 to 4, with higher scores indicating greater spasticity.
4 secondary outcomes
Incidence of reduction in neuroinflammation
Time frame: 6 months post-sessions
Assessment of quality of life
Time frame: 6 months post-sessions
Incidence of adverse effects
Time frame: 6 months post-sessions
Measurement of age-related response variability
Time frame: 6 months post-sessions
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rectal ozone sessions and Conventional rehabilitation program in people with Rectal Ozone and Neuroprotector, run by Al-Azhar University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed M Asfour, Master (00201017440223, drahmedasfour14@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of muscle Tone (time frame: 6 months post-sessions). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025; AzTrials last refreshed its copy on 6 Nov 2026.