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Effect of Probiotics on Cytokines in Sepsis in Children

NCT05467605 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2023-02-09

No results posted yet for this study

Summary

To assess the effect of probiotics on cytokine's level(interleukin 6 and Transforming growth factor-β1)in children admitted to PICU with sepsis.

Conditions

  • Sepsis, Severe

Interventions

DIETARY_SUPPLEMENT

probiotics( Lactobacillus acidophilus, lactobacillus delbruekii and lactobacillus fermentum 10 billions),

therapeutic intervention, Children will be randomized into two groups using sealed envelopes on admission after meeting inclusion criteria, group ONE will receive multi strain probiotic product which contains(Lactobacillus acidophilus, lactobacillus delbruekii and lactobacillus fermentum 10 billions),

OTHER

maltose dissolved in distilled water

the other group placebo (GROUP TWO ) will receive maltose dissolved in 10 ml distilled water .

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • AYMAN EMIL, MD · Professor of Pediatrics, Cairo University

  • HANAA RADY, MD · Professor of Pediatrics, Cairo University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
30 Days
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-22
Primary Completion
2023-01-20
Completion
2023-02-05

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05467605 on ClinicalTrials.gov