Ventriculitis, InfectiousPhase 4NCT06151392
Effect of Probiotic and Zinc Supplementations on the Clinical Outcome in Pediatric Patients With Ventriculitis
A Phase 4 study testing Probiotic Formula and Zinc in people with Ventriculitis, Infectious, run by Ain Shams University at 1 site in Egypt.
Trial summary
The aim of the study is to evaluate the effect of non-antibiotic-based supplemental interventions in the management of ventriculitis among pediatric patients. The study objective is to detect the efficacy of probiotics and zinc when taken simultaneously with antibiotic treatment as immunomodulatory in increasing the… Read more about this study
- Who is it for?
- Ages 1 month to 4 years
- Conditions the study is for
- Ventriculitis, Infectious
- What is being tested?
- Probiotic Formula and Zinc
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2023to 1 Jul 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 4 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric patients admitted to neurosurgery department with the diagnosis of ventriculitis will be enrolled in the study.
Who cannot join
- Patients suffering from any comorbidities other than ventriculitis such as cardiovascular, autoimmune diseases. etc .
- Patients with allergy to zinc.
- Patients with allergy to probiotics.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is to evaluate the effect of non-antibiotic-based supplemental interventions in the management of ventriculitis among pediatric patients.
The study objective is to detect the efficacy of probiotics and zinc when taken simultaneously with antibiotic treatment as immunomodulatory in increasing the recovery rate in pediatric population affected with ventriculitis.
Read the detailed description
Study design: A comparative, randomized, open label, controlled interventional clinical trial.
Setting:The study will be conducted at the Neurosurgery department with the Ain Shams University Hospitals.
Pediatric Patients admitted to the neurosurgery department according to the inclusion criteria will be enrolled in the study and divided into four groups using simple randomization method.
Group A: Patients administer probiotics along with the standard care of therapy for a duration of 14 days.
Lacteol fort ® Sachets manufactured by Rameda contains Lactobacillus LB corresponding to lactobacillus delbruekii and lactobacillus fermentum 10 billion units per sachet.
Dose: 5 billion units once or twice daily. Dosing and duration regimens were guided from Lexicomp Online, Pediatric and Neonatal Lexi-Drugs. https://online.lexi.com. Also, from other studies using probiotics.
Group B: Patients administering zinc supplementation along with the standard care of therapy for the duration of 14 days.
Zn origin® 10 mg/5 mL syrup is manufactured by Egyptian Group for Pharmaceutical Industries. For Origin International Pharma, every 100 mL syrup constituted of 0.8793 g Zn sulfate heptahydrate which contained 0.2 g elemental Zn. Dose:
Infants <3 months: 250 mcg elemental zinc/kg/day. Infants ≥3 months: 100 mcg elemental zinc/kg/day. Dosing and duration regimens were guided from Lexicomp Online, Pediatric and Neonatal Lexi-Drugs. https://online.lexi.com. Also, from other studies using zinc.
Group C: Patients administering probiotics and zinc supplementation along with the standard care of therapy for the duration of 14 days.
Group D: Patients administer only the standard care of therapy (control group). Patient data collection
- Demographic data:
Including age, sex, weight, height, body mass index.
- Medication and medical history:
Including patient's medical history, past surgical history, family medical history, and medications the patient is taking or may have recently stopped taking.
A patient's medical history may also include information about allergies, surgeries, immunizations, health habits, such as feeding and sleeping habits.
- Laboratory examinations The following laboratory data to be measured at baseline and after duration of treatment period of 14 days.
- CSF culture. Cultures and sensitivity tests from the suspected site of infection were withdrawn from all patients at baseline. Antibiotic susceptibility was carried out using agar diffusion and broth dilution method according to clinical and laboratory standards institute (CLSI) guidelines.
- CSF chemistry (protein and glucose level). Studies showed that CSF composition comparison had higher leukocyte count in ventriculitis cases. Also, a significantly higher CSF protein and lower CSF glucose value in ventriculitis cases.
- C-reactive protein (CRP). measured by an immunonephelometric method. CRP is considered an acute phase protein which is synthesized in liver in the presence of infection, it is usually effective in the follow-up of the infection severity.
- Procalcitonin biomarker. measured by an immunoluminometric assay. It is a 116-amino acid prohormone and is the precursor of hormone calcitonin produced by thyroid gland under normal conditions, the serum concentration of PCT increases significantly during infections. It is secreted from the liver and circulating macrophages in response to infections and could be used for the diagnosis and follow-up.
- Complete blood picture (CBC) including TLC, RBC, Monocytes and Macrophages.
- ESR
- Interleukin-6
- Signs and symptoms
Follow up the patient signs and symptoms of ventriculitis from hospital admission and during duration of treatment. The Centers for Disease Control and Prevention's National Healthcare Safety Network (CDC/NHSN) definition of healthcare-associated ventriculitis or meningitis includes at least 1 of the following criteria :
Organism cultured from CSF. At least 2 of the following symptoms with no other recognized cause in patients aged >1 year: fever >38°C or headache, meningeal signs, or cranial nerve signs, or at least 2 of the following symptoms with no other recognized cause in patients aged ≤1 year: fever >38°C or hypothermia a <36°C, apnea, bradycardia, or irritability and at least 1 of the following:
- Increased white cells, elevated protein, and decreased glucose in CSF
- Organisms seen on Gram stain of CSF
- Organisms cultured from blood
- Positive nonculture diagnostic laboratory test from CSF, blood, or urine.
- Safety and Tolerability Evaluation of the safety of probiotic supplementation and zinc in pediatric patients with ventriculitis in terms of side effects and adverse drug events.
- Patients' follow-up Patients will be followed up during their hospital stay through laboratory examination at baseline and at end of study (14 days).
- Conditions
- Ventriculitis, Infectious
- Being tested
- Probiotic Formula, Zinc
- Keywords
- Probiotic, Zinc, Pediatrics, Ventriculitis
- Medical subject headings
- Cerebral Ventriculitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic FormulaDrug
Also called lactobacillus
probiotic will be administered to pediatric patients with ventriculitis to study their possible effect in treatment
ZincDrug
Also called zinc sulfate
Zinc will be administered to pediatric patients with ventriculitis to study their possible effect in treatment
| Study group | Role | What they receive |
|---|---|---|
| Probiotic group | Active comparator | probiotic will be administered to this group of pediatric patients with ventriculitis Receives: Drug: Probiotic Formula |
| Zinc group | Active comparator | Zinc will be administered to this group of pediatric patients with ventriculitis Receives: Drug: Zinc |
| Probiotic and Zinc group | Active comparator | probiotic and Zinc will be administered to this group of pediatric patients with ventriculitis Receives: Drug: Probiotic Formula; Drug: Zinc |
| Control group | No intervention | interventional drug will not be administered to this group of pediatric patients with ventriculitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
CSF culture
time-to-event of negative CSF culture .
Measured: after 14 days of treatment
normalization of the CSF chemistry
including normal CSF protein and normal CSF glucose levels
Measured: after 14 days of treatment
safety of probiotic and zinc supplementation
Number of participants with treatment-related adverse events
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
length of hospital stay
number of days the patient stay in the hospital
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2023
- Study start1 Jul 2023
- Primary completion1 Jul 2026
- Study completion1 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventriculitis, InfectiousStudies of the same condition, open and under way.
- More trials run by Ain Shams 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06151392
- Sponsor's protocol ID
- 195
- Status last verified
- Jul 2026
- First submitted
- 22 Jul 2023
- Last updated
- 30 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Probiotic and Zinc Supplementations on the Clinical Outcome in Pediatric Patients With Ventriculitis
- ClinicalTrials.gov ID
- NCT06151392
- Acronym / sponsor ID
- 195
- Conditions
- Ventriculitis, Infectious
- Keywords
- Probiotic, Zinc, Pediatrics, Ventriculitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Jul 2026 (actual)
- Study completion
- 1 Jul 2026 (actual)
- First posted
- 30 Nov 2023 (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 study is to evaluate the effect of non-antibiotic-based supplemental interventions in the management of ventriculitis among pediatric patients.
The study objective is to detect the efficacy of probiotics and zinc when taken simultaneously with antibiotic treatment as immunomodulatory in increasing the recovery rate in pediatric population affected with ventriculitis.
Detailed description
Study design: A comparative, randomized, open label, controlled interventional clinical trial.
Setting:The study will be conducted at the Neurosurgery department with the Ain Shams University Hospitals.
Pediatric Patients admitted to the neurosurgery department according to the inclusion criteria will be enrolled in the study and divided into four groups using simple randomization method.
Group A: Patients administer probiotics along with the standard care of therapy for a duration of 14 days.
Lacteol fort ® Sachets manufactured by Rameda contains Lactobacillus LB corresponding to lactobacillus delbruekii and lactobacillus fermentum 10 billion units per sachet.
Dose: 5 billion units once or twice daily. Dosing and duration regimens were guided from Lexicomp Online, Pediatric and Neonatal Lexi-Drugs. https://online.lexi.com. Also, from other studies using probiotics.
Group B: Patients administering zinc supplementation along with the standard care of therapy for the duration of 14 days.
Zn origin® 10 mg/5 mL syrup is manufactured by Egyptian Group for Pharmaceutical Industries. For Origin International Pharma, every 100 mL syrup constituted of 0.8793 g Zn sulfate heptahydrate which contained 0.2 g elemental Zn. Dose:
Infants <3 months: 250 mcg elemental zinc/kg/day. Infants ≥3 months: 100 mcg elemental zinc/kg/day. Dosing and duration regimens were guided from Lexicomp Online, Pediatric and Neonatal Lexi-Drugs. https://online.lexi.com. Also, from other studies using zinc.
Group C: Patients administering probiotics and zinc supplementation along with the standard care of therapy for the duration of 14 days.
Group D: Patients administer only the standard care of therapy (control group). Patient data collection
- Demographic data:
Including age, sex, weight, height, body mass index.
- Medication and medical history:
Including patient's medical history, past surgical history, family medical history, and medications the patient is taking or may have recently stopped taking.
A patient's medical history may also include information about allergies, surgeries, immunizations, health habits, such as feeding and sleeping habits.
- Laboratory examinations The following laboratory data to be measured at baseline and after duration of treatment period of 14 days.
- CSF culture. Cultures and sensitivity tests from the suspected site of infection were withdrawn from all patients at baseline. Antibiotic susceptibility was carried out using agar diffusion and broth dilution method according to clinical and laboratory standards institute (CLSI) guidelines.
- CSF chemistry (protein and glucose level). Studies showed that CSF composition comparison had higher leukocyte count in ventriculitis cases. Also, a significantly higher CSF protein and lower CSF glucose value in ventriculitis cases.
- C-reactive protein (CRP). measured by an immunonephelometric method. CRP is considered an acute phase protein which is synthesized in liver in the presence of infection, it is usually effective in the follow-up of the infection severity.
- Procalcitonin biomarker. measured by an immunoluminometric assay. It is a 116-amino acid prohormone and is the precursor of hormone calcitonin produced by thyroid gland under normal conditions, the serum concentration of PCT increases significantly during infections. It is secreted from the liver and circulating macrophages in response to infections and could be used for the diagnosis and follow-up.
- Complete blood picture (CBC) including TLC, RBC, Monocytes and Macrophages.
- ESR
- Interleukin-6
- Signs and symptoms
Follow up the patient signs and symptoms of ventriculitis from hospital admission and during duration of treatment. The Centers for Disease Control and Prevention's National Healthcare Safety Network (CDC/NHSN) definition of healthcare-associated ventriculitis or meningitis includes at least 1 of the following criteria :
Organism cultured from CSF. At least 2 of the following symptoms with no other recognized cause in patients aged >1 year: fever >38°C or headache, meningeal signs, or cranial nerve signs, or at least 2 of the following symptoms with no other recognized cause in patients aged ≤1 year: fever >38°C or hypothermia a <36°C, apnea, bradycardia, or irritability and at least 1 of the following:
- Increased white cells, elevated protein, and decreased glucose in CSF
- Organisms seen on Gram stain of CSF
- Organisms cultured from blood
- Positive nonculture diagnostic laboratory test from CSF, blood, or urine.
- Safety and Tolerability Evaluation of the safety of probiotic supplementation and zinc in pediatric patients with ventriculitis in terms of side effects and adverse drug events.
- Patients' follow-up Patients will be followed up during their hospital stay through laboratory examination at baseline and at end of study (14 days).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Probiotic group | Active comparator | Drug: Probiotic Formulaprobiotic will be administered to this group of pediatric patients with ventriculitis |
| Zinc group | Active comparator | Drug: ZincZinc will be administered to this group of pediatric patients with ventriculitis |
| Probiotic and Zinc group | Active comparator | Drug: Probiotic Formula, Drug: Zincprobiotic and Zinc will be administered to this group of pediatric patients with ventriculitis |
| Control group | No intervention | –interventional drug will not be administered to this group of pediatric patients with ventriculitis |
Who may qualify
- Ages
- 1 month to 4 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Pediatric patients admitted to neurosurgery department with the diagnosis of ventriculitis will be enrolled in the study.
Key exclusion criteria (3 listed)
- Patients suffering from any comorbidities other than ventriculitis such as cardiovascular, autoimmune diseases. etc .
- Patients with allergy to zinc.
- Patients with allergy to probiotics.
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 |
|---|---|---|
| Probiotic FormulaAlso: lactobacillusprobiotic will be administered to pediatric patients with ventriculitis to study their possible effect in treatment | Drug | Probiotic and Zinc group, Probiotic group |
| ZincAlso: zinc sulfateZinc will be administered to pediatric patients with ventriculitis to study their possible effect in treatment | Drug | Probiotic and Zinc group, Zinc group |
Primary outcome
CSF culture
Time frame: after 14 days of treatment
time-to-event of negative CSF culture .
normalization of the CSF chemistry
Time frame: after 14 days of treatment
including normal CSF protein and normal CSF glucose levels
safety of probiotic and zinc supplementation
Time frame: through study completion, an average of 1 year
Number of participants with treatment-related adverse events
1 secondary outcome
length of hospital stay
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Probiotic Formula and Zinc in people with Ventriculitis, Infectious, run by Ain Shams 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 1 inclusion and 3 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: finished, as of the sponsor's last update on 30 Oct 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CSF culture (time frame: after 14 days of treatment). The study lists 3 primary outcomes in all. 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 30 Oct 2026.