Ignite Creation Date:
2024-05-06 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06151392
Status:
RECRUITING
Last Update Posted:
2023-11-30
First Post:
2023-07-22
Brief Title:
Effect of Probiotic and Zinc Supplementations on the Clinical Outcome in Pediatric Patients With Ventriculitis
Sponsor:
Ain Shams University
Organization:
Ain Shams University
Study Overview
Official Title:
Effect of Probiotic and Zinc Supplementations on the Clinical Outcome in Pediatric Patients With Ventriculitis
Status:
RECRUITING
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 recovery rate in pediatric population affected with ventriculitis
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
SettingThe 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 httpsonlinelexicom 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 mg5 mL syrup is manufactured by Egyptian Group for Pharmaceutical Industries For Origin International Pharma every 100 mL syrup constituted of 08793 g Zn sulfate heptahydrate which contained 02 g elemental Zn Dose
Infants 3 months 250 mcg elemental zinckgday Infants 3 months 100 mcg elemental zinckgday Dosing and duration regimens were guided from Lexicomp Online Pediatric and Neonatal Lexi-Drugs httpsonlinelexicom 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 patients medical history past surgical history family medical history and medications the patient is taking or may have recently stopped taking
A patients 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 Preventions National Healthcare Safety Network CDCNHSN 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 38C 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 38C or hypothermia a 36C 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
SettingThe 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 httpsonlinelexicom 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 mg5 mL syrup is manufactured by Egyptian Group for Pharmaceutical Industries For Origin International Pharma every 100 mL syrup constituted of 08793 g Zn sulfate heptahydrate which contained 02 g elemental Zn Dose
Infants 3 months 250 mcg elemental zinckgday Infants 3 months 100 mcg elemental zinckgday Dosing and duration regimens were guided from Lexicomp Online Pediatric and Neonatal Lexi-Drugs httpsonlinelexicom 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 patients medical history past surgical history family medical history and medications the patient is taking or may have recently stopped taking
A patients 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 Preventions National Healthcare Safety Network CDCNHSN 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 38C 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 38C or hypothermia a 36C 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None