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IRCT20170202032367N10 IRCT 2023-08-15 Tehran University of Medical Sciences Probiotic supplementation and sepsis The effects of probiotic supplementation on intestinal permeability, inflammatory factors and clinical status in pediatrics with severe sepsis: a randomized double blind clinical trial 2023-08-23 anticipated 44 Complete https://irct.ir/trial/71965 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random allocation will be done by Stratified Permuted Block Randomization method. Stratification is done based on the NPO variable. Eligible people who meet the criteria for entering the study, are selected, and then the two groups are randomly divided into 4 or 6 intervention blocks at a ratio of 1:1. Then, the list of blocks is divided equally between the two strata. Block randomization (4 or 6 people in each block) is done using the website www.randomization.com. In this way, the letters A and B will be spread between the patient codes. Numbers will be assigned to patients according to the order of participants' entry, and patients will be enrolled in the study based on special letters (A and B), Blinding description: Blinding of patients: due to the fact that in this study, the patients are children under 12 years old and usually do not have optimal GCS, people in each group do not know the type of intervention. In order to blind the researcher, the probiotic supplements and placebo will be delivered to the supervisor by the bio-fermentation company. Probiotic and placebo supplements are similar in appearance and packaging. 3 Severe sepsis. Intervention 1: Intervention group: Probiotic (KidiLact ZistTakhmir Company); Lactobacillus rhamnosus, Lactobacillus rotrilactobacillus Acidophilus, Lactobacillus bulgarico, Lactobacillus caseibifidobacterium infantis, Bifidobacterium brohbifidobacterium, Bifidobacterium bifidombifidobacterium, Lactistreptococcus thermophilus, 109 CFU per sachet, 1 gram, twice a day; 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 condition of the patients. became. To prepare the supplement, mix the contents of one sachet in 5 ml of sterile water and use immediately. Intervention 2: Control group: placebo (corn starch); 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 condition of the patients. will be. To prepare, mix the contents of one sachet in 5 ml of sterile water and use immediately. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information
public Maryam Safabakhsh
School of Nutritional Sciences & Dietetics, Tehran University of Medical Sciences, No: 44 Hojjat-dost Alley, Naderi St.
Tehran Iran (Islamic Republic of) 1419733151 +98 912 263 8696 maryam.safa@yahoo.com Tehran University of Medical Sciences scientific Maryam Safabakhsh
School of Nutritional Sciences & Dietetics, Tehran University of Medical Sciences, No: 44 Hojjat-dost Alley, Naderi St.
Tehran Iran (Islamic Republic of) 1419733151 +98 912 263 8696 maryam.safa@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Aged 1-12 years old Diagnosis of severe sepsis according to pediatric sepsis consensus conference 2005 criteria in children admitted to PICU 1 year 12 years Both 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 R65.2 Severe sepsis Treatment - Drugs Placebo Intervention group: Probiotic (KidiLact ZistTakhmir Company); Lactobacillus rhamnosus, Lactobacillus rotrilactobacillus Acidophilus, Lactobacillus bulgarico, Lactobacillus caseibifidobacterium infantis, Bifidobacterium brohbifidobacterium, Bifidobacterium bifidombifidobacterium, Lactistreptococcus thermophilus, 109 CFU per sachet, 1 gram, twice a day; 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 condition of the patients. became. To prepare the supplement, mix the contents of one sachet in 5 ml of sterile water and use immediately. Control group: placebo (corn starch); 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 condition of the patients. will be. To prepare, mix the contents of one sachet in 5 ml of sterile water and use immediately. 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. 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 on treatment-related infection incidence duration of the study (7 days). Method of measurement: Questionnaire forms. Type of treatment-related infection. Timepoint: The effect of probiotic supplementation on type of treatment-related infection duration of the study (7 days). Method of measurement: Questionnaire forms. Change in incidence of Multiple Organ Dysfunction Syndrome (MODS). Timepoint: The effect of probiotic supplementation on change in incidence of Multiple Organ Dysfunction Syndrome (MODS) duration of the study (7 days). Method of measurement: Calculation. The length of PICU stay. Timepoint: The effect of probiotic supplementation on the length of PICU stay duration of the study (7 days). Method of measurement: Questionnaire forms. Mortality. Timepoint: The effect of probiotic supplementation on mortality duration of the study (7 days). Method of measurement: Questionnaire forms. Tehran University of Medical Sciences Approved 2023-08-09 Children's Medical Center-Tehran University of Medical sciences Children's Medical Center, Dr Gharib St, Keshavarz Blvd, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)