Effect of Probiotics on Cytokines in Sepsis in Children

NCT05467605 | Completed

• 1 other identifier: probiotics in pediatric sepsis
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 1- To assess the effect of probiotics on cytokine levels(interleukin 6 and Transforming growth factor-β1) in probiotic group

  To assess the effect of probiotics on cytokine levels(interleukin 6 and Transforming growth factor-β1) in probiotic group and To assess the change on cytokine levels (interleukin 6 and Transforming growth factor-β1) from day 1 to 7 in critically ill children with sepsis in two groups.

  one week

Secondary Outcomes (3)

• assessment of other sepsis parameters

  up to 2 weeks

• assessment of patient general condition during pediatric intensive care admission

  through admission till discharge from PICU up to one month

• assessment of patient general condition during pediatric intensive care admission

  through admission till discharge from PICU up to one month

Study Arms (2)

CASE, GROUP ONE

ACTIVE COMPARATOR

Group 1 (group who will receive probiotics): one sachet contains(Lactobacillus acidophilus, lactobacillus delbruekii and lactobacillus fermentum 10 billions), dissolved in 10 ml distilled water twice a day for 7days orally or through nasogastric/orogastric tube depending on clinical status of patients.

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

CONTROL, GROUP 2

PLACEBO COMPARATOR

GROUP 2 will receive only maltose dissolved in 10 ml of distilled water twice a day for 7 days orally or though nasogastric/orogastric tube depending on clinical status of patients.

Other: maltose dissolved in distilled water

Interventions

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

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),

Also known as: LACTEOL FORTE

CASE, GROUP ONE

maltose dissolved in distilled water OTHER

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

CONTROL, GROUP 2

Eligibility Criteria

• Age: 30 Days - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• The study will include children admitted to PICU with sepsis defined as presence of suspected or proven infection with two or more criteria for systemic inflammatory response syndrome (SIRS)

You may not qualify if:

• Children having contraindications to start enteral feeding.
• Children with known chronic gastrointestinal illness.
• Children known with immunodeficiency.
• Children on prior steroids or immunotherapy.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University Faculty of Medicine

Cairo, Egypt

Location

Related Publications (2)

• Angurana SK, Bansal A, Singhi S, Aggarwal R, Jayashree M, Salaria M, Mangat NK. Evaluation of Effect of Probiotics on Cytokine Levels in Critically Ill Children With Severe Sepsis: A Double-Blind, Placebo-Controlled Trial. Crit Care Med. 2018 Oct;46(10):1656-1664. doi: 10.1097/CCM.0000000000003279.

  PMID: 29957709 RESULT

• Chaudhry H, Zhou J, Zhong Y, Ali MM, McGuire F, Nagarkatti PS, Nagarkatti M. Role of cytokines as a double-edged sword in sepsis. In Vivo. 2013 Nov-Dec;27(6):669-84.

  PMID: 24292568 RESULT

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• AYMAN EMIL, MD

  Professor of Pediatrics, Cairo University

  STUDY DIRECTOR

• HANAA RADY, MD

  Professor of Pediatrics, Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: June 27, 2022
• First Posted: July 20, 2022
• Study Start: July 22, 2022
• Primary Completion: January 20, 2023
• Study Completion: February 5, 2023
• Last Updated: February 9, 2023

Record last verified: 2023-02

Locations

EG (1)