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

NCT06151392 | Recruiting Phase 4

• 1 other identifier: 195
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventriculitis, Infectious

Keywords

Probiotic; Zinc; Pediatrics; Ventriculitis

Outcome Measures

Primary Outcomes (3)

• CSF culture

  time-to-event of negative CSF culture .

  after 14 days of treatment

• normalization of the CSF chemistry

  including normal CSF protein and normal CSF glucose levels

  after 14 days of treatment

• safety of probiotic and zinc supplementation

  Number of participants with treatment-related adverse events

  through study completion, an average of 1 year

Secondary Outcomes (1)

• length of hospital stay

  through study completion, an average of 1 year

Study Arms (4)

Probiotic group

ACTIVE COMPARATOR

probiotic will be administered to this group of pediatric patients with ventriculitis

Drug: Probiotic Formula

Zinc group

ACTIVE COMPARATOR

Zinc will be administered to this group of pediatric patients with ventriculitis

Drug: Zinc

Probiotic and Zinc group

ACTIVE COMPARATOR

probiotic and Zinc will be administered to this group of pediatric patients with ventriculitis

Drug: Probiotic Formula; Drug: Zinc

Control group

NO INTERVENTION

interventional drug will not be administered to this group of pediatric patients with ventriculitis

Interventions

Probiotic Formula DRUG

probiotic will be administered to pediatric patients with ventriculitis to study their possible effect in treatment

Also known as: lactobacillus

Probiotic and Zinc group; Probiotic group

Zinc DRUG

Zinc will be administered to pediatric patients with ventriculitis to study their possible effect in treatment

Also known as: zinc sulfate

Probiotic and Zinc group; Zinc group

Eligibility Criteria

• Age: 1 Month - 4 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain shams university

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Cerebral Ventriculitis

Interventions

Lacteol; Zinc; Zinc Sulfate

Condition Hierarchy (Ancestors)

Central Nervous System Viral Diseases; Central Nervous System Infections; Infections; Encephalitis; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuroinflammatory Diseases

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Zinc Compounds

Central Study Contacts

Lobna Saad, PHD student

CONTACT

01008006749; lobnadarwish@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2023
• First Posted: November 30, 2023
• Study Start: July 1, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 25, 2025

Record last verified: 2024-12

Locations

EG (1)