Effect of Probiotic and Zinc Supplementations on the Clinical Outcome in Pediatric Patients With Ventriculitis

November 21, 2023 updated by: Ain Shams University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

A. Demographic data:

Including age, sex, weight, height, body mass index.

B. 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.

C. Laboratory examinations The following laboratory data to be measured at baseline and after duration of treatment period of 14 days.

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. Complete blood picture (CBC) including TLC, RBC, Monocytes and Macrophages.
  6. ESR
  7. Interleukin-6

D. 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.

E. 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.

F. 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 Type

Interventional

Enrollment (Estimated)

140

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

• Pediatric patients admitted to neurosurgery department with the diagnosis of ventriculitis will be enrolled in the study.

Exclusion Criteria:

  • Patients suffering from any comorbidities other than ventriculitis such as cardiovascular, autoimmune diseases. etc .
  • Patients with allergy to zinc.
  • Patients with allergy to probiotics.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Probiotic group
probiotic will be administered to this group of pediatric patients with ventriculitis
Drug: Probiotic Formula
probiotic will be administered to pediatric patients with ventriculitis to study their possible effect in treatment
Other Names:
  • lactobacillus
Active Comparator: Zinc group
Zinc will be administered to this group of pediatric patients with ventriculitis
Drug: Zinc
Zinc will be administered to pediatric patients with ventriculitis to study their possible effect in treatment
Other Names:
  • zinc sulfate
Active Comparator: Probiotic and Zinc group
probiotic and Zinc will be administered to this group of pediatric patients with ventriculitis
Drug: Probiotic Formula
probiotic will be administered to pediatric patients with ventriculitis to study their possible effect in treatment
Other Names:
  • lactobacillus
Drug: Zinc
Zinc will be administered to pediatric patients with ventriculitis to study their possible effect in treatment
Other Names:
  • zinc sulfate
No Intervention: Control group
interventional drug will not be administered to this group of pediatric patients with ventriculitis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CSF culture
Time Frame: after 14 days of treatment
time-to-event of negative CSF culture .
after 14 days of treatment
normalization of the CSF chemistry
Time Frame: after 14 days of treatment
including normal CSF protein and normal CSF glucose levels
after 14 days of treatment
safety of probiotic and zinc supplementation
Time Frame: through study completion, an average of 1 year
Number of participants with treatment-related adverse events
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
length of hospital stay
Time Frame: through study completion, an average of 1 year
number of days the patient stay in the hospital
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

July 22, 2023

First Submitted That Met QC Criteria

November 21, 2023

First Posted (Actual)

November 30, 2023

Study Record Updates

Last Update Posted (Actual)

November 30, 2023

Last Update Submitted That Met QC Criteria

November 21, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 195 (CTEP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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