Effect of Probiotics on Cytokines in Sepsis in Children
Condition: Sepsis, Severe
MeSH terms: Sepsis; Toxemia
Study type: Interventional

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.
    

Detailed description: 
      Sepsis, defined as an infection with deregulated host response leading to life-threatening
      organ dysfunction. Historically, the term sepsis has been used to characterize
      life-threatening infections usually caused by bacterial pathogens if untreated progress to
      shock and death, It contributes to 19% of all deaths globally, with the highest age-specific
      incidence in children younger than 5 years of age. Pediatric sepsis resulted in 0.7% of all
      hospital encounters. Epidemiologic studies found an incidence of pediatric sepsis in up to 8%
      of all pediatric intensive care unit (PICU) admissions, contributing to 1in 4 deaths in
      PICUs.

      Despite many advances in diagnosis and management, sepsis is associated with significant
      morbidity and mortality in pediatric population. The pathophysiology of systemic inflammatory
      response syndrome (SIRS)and sepsis is characterized by hyperactive and deregulated endogenous
      inflammatory mediators in a sequential manner resulting in a cytokine cascade.

      Cytokines are regulators of the immune response to infection and play a key role in
      regulating inflammation and trauma. There are two types of cytokines. Pro-inflammatory
      cytokines and anti-inflammatory cytokines.

      Pro-inflammatory cytokines(tumor necrosis factor [TNF]-α, interferon-γ, interleukin[IL]-1α,
      IL-1β, IL-6, IL-8, IL-12, IL-17) are important for initiation of an effective inflammatory
      response against pathogens, whereas their excess production can lead to multiple organ
      dysfunction syndrome (MODS) and mortality, on the other side, anti-inflammatory cytokines
      (IL-4, IL-10, IL-13,transforming growth factor [TGF]-β) are required for controlling and
      down-regulating the inflammatory response and if severe can lead to depression of the immune
      system.

      The levels of these cytokines rise within few hours of onset of sepsis and remain elevated
      for days together depending on severity and duration of sepsis, baseline host factors, timing
      of sampling relative to onset of sepsis/septic shock, and inter-individual variation.

      The gastrointestinal system seems to play a key role in the pathogenesis MODS owing to a
      breakdown of intestinal barrier function and increased translocation of bacteria and
      bacterial components into the systemic circulation.

      During critical illness, alterations occur in gut micro flora owing to change in circulating
      stress hormones, gut ischemia, immune suppression, the use of antibiotics, and lack of
      nutrients due to delay in starting enteral feeding.

      Probiotics are living micro-organisms that, when administered in adequate amounts, can help
      maintain the integrity of the intestinal barrier function by modulating the immune response.
      Such administration has been included in the management of critically ill patients as a
      therapeutic approach.

      Various studies highlighted that probiotics can modulate intestinal micro biota by colonizing
      human GIT, preventing overgrowth of pathogens, normalizing altered intestinal flora, reducing
      bacterial translocation, influencing immune system, and balancing control of pro-inflammatory
      and anti-inflammatory Cytokines.
    

Intervention name(s): probiotics( Lactobacillus acidophilus, lactobacillus delbruekii and lactobacillus fermentum 10 billions),; maltose dissolved in distilled water
Intervention type(s): Dietary Supplement; Other
Intervention description(s): 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),; the other group placebo (GROUP TWO ) will receive maltose dissolved in 10 ml distilled water .
Other intervention name(s): LACTEOL FORTE
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Supportive Care