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

ConditionVentriculitis, Infectious
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age1-4
SponsorAin Shams University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • Probiotic Formula

    Drug

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

  • Zinc

    Drug

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

Treatment groups

140 Participants
are divided into 4 treatment groups
Group A: Probiotic groupActive comparator 1 intervention
Group B: Zinc groupActive comparator 1 intervention
Group C: Probiotic and Zinc groupActive comparator 2 interventions
Group D: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

CSF culture

time-to-event of negative CSF culture .

Time frame
after 14 days of treatment
2

normalization of the CSF chemistry

including normal CSF protein and normal CSF glucose levels

Time frame
after 14 days of treatment
3

safety of probiotic and zinc supplementation

Number of participants with treatment-related adverse events

Time frame
through study completion, an average of 1 year

Secondary outcomes

1

length of hospital stay

number of days the patient stay in the hospital

Time frame
through study completion, an average of 1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ain Shams University

Lead sponsor

Source ClinicalTrials.gov
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