Severe sepsis. Severe sepsis
Conditions
Interventions
Intervention 1: Intervention group: Probiotic (KidiLact ZistTakhmir Company)
Lactobacillus rhamnosus, Lactobacillus rotrilactobacillus Acidophilus, Lactobacillus bulgarico, Lactobacillus caseibifidobacterium infantis, Bifidobacterium brohbifidobacterium, Bifidobacterium bifido
Probiotics will be given in doses of one sachet twice a day with an interval of 12 hours for 7 days orally or through enteral feeding through a Nasogastric or Orogastric tube depending on the clinical
Placebo wasgiven in doses of one 1 gram sachet twice a day with an interval of 12 hours for 7 days orally or through enteral feeding through Nasogastric or Orogastric tube depending on the clinical co
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
1 Years to 12 Years
Inclusion criteria
Inclusion criteria: Aged 1-12 years old Diagnosis of severe sepsis according to pediatric sepsis consensus conference 2005 criteria in children admitted to PICU
Exclusion criteria
Exclusion criteria: PICU admission more than 72 hours Ileus, overt gastrointestinal bleeding, anatomic obstruction of the gastrointestinal tract (eg, volvulus, intestinal atresia), recent esophageal or gastrointestinal surgery Gastrointestinal diseases such as celiac disease, inflammatory bowel disease (IBD), short bowel syndrome (SBS), irritable bowel syndrome (IBS) Use of feeding routes leading to jejunum such as jejunostomy Probiotic use one month before entering the study Use of steroids and other immunosuppressive drugs Suffering from immunosuppressive diseases such as malignant tumors, acquired immunodeficiency syndrome, etc. Severe acute malnutrition (According to the World Health Organization: Z-Score weight for height/length and BMI less than -3 SD average child growth standards WHO
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum Zonulin. Timepoint: Measurement of the serum level of zonulin in the initial study (before the start of the intervention) and 7 days after the start of probiotic consumption. Method of measurement: ELISA.;Serum LPS-Binding Protein. Timepoint: Measurement of the serum level of lipopolysaccharide binding protein (LBP) in the initial study (before the start of the intervention) and 7 days after the start of probiotic consumption. Method of measurement: ELISA.;Serum IL-6. Timepoint: Measurement of the serum level of Interleukin 6 (IL-6) in the initial study (before the start of the intervention) and 7 days after the start of probiotic consumption. Method of measurement: ELISA.;Serum IL-10. Timepoint: Measurement of the serum level of Interleukin 10 (IL-10) in the initial study (before the start of the intervention) and 7 days after the start of probiotic consumption. Method of measurement: ELISA.;Serum CRP. Timepoint: Measurement of the serum level of C-reactive protein (CRP) in the initial study (before the start of the intervention) and 7 days after the start of probiotic consumption. Method of measurement: ELISA. | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of starting nutrition. Timepoint: The effect of probiotic supplementation on the length of starting nutrition duration of the study (7 days). Method of measurement: Questionnaire forms.;The number of days to reach the nutritional goal. Timepoint: The effect of probiotic supplementation on the number of days to reach the nutritional goal duration of the study (7 days). Method of measurement: Questionnaire forms.;Nutrition intolerance. Timepoint: The effect of probiotic supplementation on nutrition intolerance duration of the study (7 days). Method of measurement: Questionnaire forms.;Need to vasoactive agents. Timepoint: The effect of probiotic supplementation on need to vasoactive agents duration of the study (7 days). Method of measurement: Questionnaire forms.;The length of vasoactive use. Timepoint: The effect of probiotic supplementation on the length of vasoactive use duration of the study (7 days). Method of measurement: Questionnaire forms.;Vasoactive inotropic score. Timepoint: The effect of probiotic supplementation on vasoactive inotropic score duration of the study (7 days). Method of measurement: Calculation.;Need to mechanical ventilation. Timepoint: The effect of probiotic supplementation on need to mechanical ventilation duration of the study (7 days). Method of measurement: Questionnaire forms.;The length of using mechanical ventilation. Timepoint: The effect of probiotic supplementation on the length of using mechanical ventilation duration of the study (7 days). Method of measurement: Questionnaire forms.;Antibiotics use. Timepoint: The effect of probiotic supplementation on antibiotics use duration of the study (7 days). Method of measurement: Questionnaire forms.;The length of antibiotic use. Timepoint: The effect of probiotic supplementation on the length of antibiotic use duration of the study (7 days). Method of measurement: Questionnaire forms.;Treatment-related infection incidence. Timepoint: The effect of probiotic supplementation | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMaryam Safabakhsh
Tehran University of Medical Sciences
Outcome results
None listed