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IRCT20211006052684N1 IRCT 2021-10-19 Esfahan University of Medical Sciences Effect of probiotics on multiple trauma patients PROTIN Effect of enteral probiotics on prognostic scores and C-reactive protein levels in critically ill multiple trauma patients: A double-blind placebo-controlled randomized clinical trial 2021-10-23 anticipated 80 Complete https://irct.ir/trial/59149 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Stratified randomization based on sex and APACHE II scores will be used and a random list will be generated using Excel. The random list of will be generated using the random function of Excel software. The person giving the intervention will not have access to the list and after list generation, drugs/placebo, anonymously, will be handed over to the person involved in intervention allocation, Blinding description: Drugs and placebo will be kept with a person who is not involved in patient selection and allocating the intervention. After enrolment of qualified individuals based on inclusion and exclusion criteria, drug/placebo boxes will be released to the person giving the intervention. After data analysis, the placebo and intervention group will be revealed. 3 Traumatic patients. Intervention 1: Intervention group: Two Lactocare probiotic capsules from Zisttakhmir pharmaceuticals will be given to the intervention group every 12 hours for a total of 7 days. The route of administration will be oral or by a nasogastric tube. Each Lactocare capsule contains fructooligosaccharide as prebiotic and Lactobacillus casei, Lactobacillus acidophilus, Lactobacillus rhamnosus, Lactobacillus bulgaricus, Bifidobacterium breve, Bifidobacterium longum, and Streptococcus thermophilus as the probiotic blend (probiotic blend: 10^9 colony forming unit (CFU)). The total number of capsules given to each patient for the total intervention time will be 28 capsules. Intervention 2: Control group: two placebo capsules identical to the original Lactocare probiotic capsules will be given to each patient in the control group every 12 hours for a total of 7 days. The placebo capsules will be provided by Zisttakhmir Pharmaceutical company. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Amirhossein Akhavan Sigari
Alzahra University Hospital, Soffe Blvd
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3668 8092 amirsigari@aol.com Esfahan University of Medical Sciences scientific Amirhossein Akhavan Sigari
Alzahra University Hospital, Soffe Blvd
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3668 8092 amirsigari@aol.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Patients who are admitted to the intensive care unit (ICU) due to trauma Patients older than 18 and younger than 70 years Patients who are expected to stay in the ICU for 7 days or more 18 years 70 years Both Patients who do not consent to participate in the study. Patients who have absolute contraindication to enteral feeding or the use of probiotics. Pregnant patients Patients with an APACHE II score of more than 34 (mortality rate of 85% and higher) T07 Unspecified multiple injuries Treatment - Drugs Placebo Intervention group: Two Lactocare probiotic capsules from Zisttakhmir pharmaceuticals will be given to the intervention group every 12 hours for a total of 7 days. The route of administration will be oral or by a nasogastric tube. Each Lactocare capsule contains fructooligosaccharide as prebiotic and Lactobacillus casei, Lactobacillus acidophilus, Lactobacillus rhamnosus, Lactobacillus bulgaricus, Bifidobacterium breve, Bifidobacterium longum, and Streptococcus thermophilus as the probiotic blend (probiotic blend: 10^9 colony forming unit (CFU)). The total number of capsules given to each patient for the total intervention time will be 28 capsules. Control group: two placebo capsules identical to the original Lactocare probiotic capsules will be given to each patient in the control group every 12 hours for a total of 7 days. The placebo capsules will be provided by Zisttakhmir Pharmaceutical company. Quantitative C-reactive protein (QCRP). Timepoint: Before and 7 days after the beginning of intervention. Method of measurement: Laboratory Kit. The Acute Physiology and Chronic Health Evaluation II score (APACHE II). Timepoint: Before and 7 days after the beginning of intervention. Method of measurement: Based on the APACHE II score table. The Simplified Acute Physiology Score (SAPS II). Timepoint: Before and 7 days after the beginning of intervention. Method of measurement: Based on the SAPS II score table. Sequential Organ Failure Assessment (SOFA). Timepoint: Before and 7 days after the beginning of intervention. Method of measurement: Based on the SOFA score table. 28-day mortality. Timepoint: 28 days after the start of the intervention. Method of measurement: Questionnaire. Time to discharge. Timepoint: At the time of patient discharge. Method of measurement: Total days from the start of intervention to discharge. Esfahan University of Medical Sciences Approved 2021-09-26 Research Ethics Committees of School of Medicine - Isfahan University of Medical Sciences Alzahra University Hospital, Soffe Blvd Isfahan Isfehan Iran (Islamic Republic of)