ProbioticNCT07848165
Probiotic Role in Prevention of Ventilator Associated Pneumonia in Critically- Ill Children Admitted at Pediatric Intensive Care Unit
A study testing Probiotics and Standard management in people with Probiotic and Ventilator Associated Pneumonia, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of the work is to evaluate the impact of Probiotics supplementation on prevention of ventilator associated pneumonia in critically ill children admitted at Pediatric Intensive Care Unit at Tanta University Hospitals. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Probiotic, Ventilator Associated Pneumonia, Critically- Ill Children
- What is being tested?
- Probiotics and Standard management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2026to 1 Feb 2027
- 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
- Critically ill children from 1 month to 18 years.
- Both sexes.
- Ventilated not due to chest infection.
Who cannot join
- Children recently received enteral vaccines.
- Children receiving chronic immunosuppressive such as chemotherapy agents. and immunosuppressive medications, and high dose corticosteroids (more than 1 milligram per kilogram).
- Children with contraindications of enteral feeding.
- Children with gastrointestinal bleeding.
- Children with open wounds following major surgery.
- Children with short gut syndrome.
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
Tanta University
Tanta, Al Gharbia, 31739
Yomna G El-Feky, MD, 00201005562005, Youmna.elfeky@med.tanta.edu.eg
About this study
Official title: Assessment of Probiotic Role in Prevention of Ventilator Associated Pneumonia in Critically- Ill Children Admitted at Pediatric Intensive Care Unit
The aim of the work is to evaluate the impact of Probiotics supplementation on prevention of ventilator associated pneumonia in critically ill children admitted at Pediatric Intensive Care Unit at Tanta University Hospitals.
Read the detailed description
Critically ill children are the children whom requiring, or potentially requiring, high reliance or serious consideration whether in medical, surgical or trauma-related fields.
Based on the time of onset of Ventilator Associated Pneumonia (VAP), it can be divided into two types. Early-onset VAP occurs during the first four days of mechanical ventilation and is usually caused by antibiotic sensitive bacteria. Late-onset VAP develops five or more days after initiation of MV and is caused by multidrug-resistant (MDR) pathogens .VAP is associated with a high rate of all-cause mortality and a prolonged duration of mechanical ventilation and intensive care unit stay.
- Being tested
- Probiotics, Standard management
- Medical subject headings
- Pneumonia, Ventilator-Associated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticsDrug
Critically ill ventilated children will receive standard management plus probiotics.
Standard managementOther
Critically ill ventilated children will receive standard management only.
| Study group | Role | What they receive |
|---|---|---|
| Group I | Experimental | Critically ill ventilated children will receive standard management plus probiotics. Receives: Drug: Probiotics |
| Group II | Active comparator | Critically ill ventilated children will receive standard management only. Receives: Other: Standard management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of ventilator-associated pneumonia
Incidence of ventilator-associated pneumonia (VAP) diagnosed according to predefined CDC/NHSN pediatric criteria
Measured: During the first 28 days after initiation of mechanical ventilation
Secondary outcomes (3)
Duration of mechanical ventilation
Duration of invasive mechanical ventilation will be measured in days from initiation of mechanical ventilation until successful extubation.
Measured: Up to 28 days
Pediatric intensive care unit length of stay
Pediatric intensive care unit (PICU) length of stay will be measured in days from PICU admission until PICU discharge.
Measured: Up to 28 days
Incidence of mortality
Incidence of mortality will be recorded.
Measured: Up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study start1 Jul 2026
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ProbioticStudies of the same condition, open and under way.
- 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
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yomna Gaber El-Feky, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07848165
- Sponsor's protocol ID
- 36264MS985/6/25
- Status last verified
- Sep 2026
- First submitted
- 19 Sep 2026
- Last updated
- 29 Sep 2026
- 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 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Probiotic Role in Prevention of Ventilator Associated Pneumonia in Critically- Ill Children Admitted at Pediatric Intensive Care Unit
- ClinicalTrials.gov ID
- NCT07848165
- Acronym / sponsor ID
- 36264MS985/6/25
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 29 Sep 2026 (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.
The aim of the work is to evaluate the impact of Probiotics supplementation on prevention of ventilator associated pneumonia in critically ill children admitted at Pediatric Intensive Care Unit at Tanta University Hospitals.
Detailed description
Critically ill children are the children whom requiring, or potentially requiring, high reliance or serious consideration whether in medical, surgical or trauma-related fields.
Based on the time of onset of Ventilator Associated Pneumonia (VAP), it can be divided into two types. Early-onset VAP occurs during the first four days of mechanical ventilation and is usually caused by antibiotic sensitive bacteria. Late-onset VAP develops five or more days after initiation of MV and is caused by multidrug-resistant (MDR) pathogens .VAP is associated with a high rate of all-cause mortality and a prolonged duration of mechanical ventilation and intensive care unit stay.
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 | Drug: ProbioticsCritically ill ventilated children will receive standard management plus probiotics. |
| Group II | Active comparator | Other: Standard managementCritically ill ventilated children will receive standard management only. |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Critically ill children from 1 month to 18 years.
- Both sexes.
- Ventilated not due to chest infection.
Key exclusion criteria (6 listed)
- Children recently received enteral vaccines.
- Children receiving chronic immunosuppressive such as chemotherapy agents. and immunosuppressive medications, and high dose corticosteroids (more than 1 milligram per kilogram).
- Children with contraindications of enteral feeding.
- Children with gastrointestinal bleeding.
- Children with open wounds following major surgery.
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 |
|---|---|---|
| ProbioticsCritically ill ventilated children will receive standard management plus probiotics. | Drug | Group I |
| Standard managementCritically ill ventilated children will receive standard management only. | Other | Group II |
Primary outcome
Incidence of ventilator-associated pneumonia
Time frame: During the first 28 days after initiation of mechanical ventilation
Incidence of ventilator-associated pneumonia (VAP) diagnosed according to predefined CDC/NHSN pediatric criteria
3 secondary outcomes
Duration of mechanical ventilation
Time frame: Up to 28 days
Pediatric intensive care unit length of stay
Time frame: Up to 28 days
Incidence of mortality
Time frame: Up to 28 days
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 29 Sep 2026.
- 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.
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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 Probiotics and Standard management in people with Probiotic and Ventilator Associated Pneumonia, run by Tanta 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 3 inclusion and 6 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 29 Sep 2026. 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 Yomna G El-Feky, MD (00201005562005, Youmna.elfeky@med.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of ventilator-associated pneumonia (time frame: During the first 28 days after initiation of mechanical ventilation). 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 29 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.