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IRCT20210708051822N1 IRCT 2021-08-02 Iran University of Medical Sciences Effect of probiotics in the therapy of Pediatrics Burn پروبیوتیک در سوختگی Effect of probiotics in the therapy of Pediatrics thermal Burn: A prospective double- blind, controlled clinical trial 2021-08-23 anticipated 100 Complete https://irct.ir/trial/57410 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: After hospitalization, patients will be divided in two group of case (probiotic) and control(placebo) by simple randomization, Blinding description: The packages of probiotic and placebo will be designed in the same form. Only principle investigator knows the content of packages . Patient and investigator or clinician are blind. 2-3 Thermal Burn in children. Intervention 1: Intervention group: Probiotic supply group that will receive oral package including 1- lactobacillus rhamnosus 2- lactobacillus rotteri 3- lactobacillus acidophilus 4-lactobacillusbulgaricus 5- lactobacillus casei 6-Bifidobacterium infantis 7-Bifidobacterium breve 8-Bifidobacterium bifidum 9-Bifidobacterium lactis 10- Streptococcus thermophilus with density of CFU 109 plus prebiotic of Fructooligosaccharides. This package is Gluten free and produced by Farabiotic Company . This oral powder will be used twice daily for 14 days by 50 cases of control group. Intervention 2: Control group: They will receive a package of placebo including food material and in the same form of probiotic package. The oral placebo is produced by Farabiotic company and will be used by 50 cases of control group twice daily for 14 days. 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 are no more information.
public Hossein Masoumi Asl
No 9, Frereshte yekom Ave, Fereshteghak St, Marzdaran Blv, Tehran
تهران Iran (Islamic Republic of) 1463774188 +98 21 4438 0119 masoumiasl.h@iums.ac.ir Iran University of Medical Sciences scientific Hossein Masoumi Asl
No. 9, Fereshte yekom, fereshteghan st. , Marzdaran Blv, Tehran
Tehran Iran (Islamic Republic of) 1463774188 +98 21 4438 0119 masoumiasl.h@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Children between 1-15 years old Burn with total body surface area 10-50% Burn with deep area between 5-10% 1 year 15 years Both Children with chronic GI diseases Children with chronic diseases for example diabetes Children with upper respiratory tract or inhalation injury Children with hereditary and congenital immune system disorders children with chemical and electrical burn T20-T32 Burn and corrosion Treatment - Other Treatment - Other Intervention group: Probiotic supply group that will receive oral package including 1- lactobacillus rhamnosus 2- lactobacillus rotteri 3- lactobacillus acidophilus 4-lactobacillusbulgaricus 5- lactobacillus casei 6-Bifidobacterium infantis 7-Bifidobacterium breve 8-Bifidobacterium bifidum 9-Bifidobacterium lactis 10- Streptococcus thermophilus with density of CFU 109 plus prebiotic of Fructooligosaccharides. This package is Gluten free and produced by Farabiotic Company . This oral powder will be used twice daily for 14 days by 50 cases of control group. Control group: They will receive a package of placebo including food material and in the same form of probiotic package. The oral placebo is produced by Farabiotic company and will be used by 50 cases of control group twice daily for 14 days. The rate of infection in thermal burn of children. Timepoint: Zero (admission day), 4, 7 and 14 day and until one year after hospitalization. Method of measurement: To calculate the number of positive culture reported by laboratory in thermal burn of children according to patients file. The length of hospital stay in thermal burn of children. Timepoint: Time of discharge or death. Method of measurement: To calculate the length of hospital stay on the time of discharge or death according to patients file. The need to skin graft in thermal burn of children. Timepoint: From discharge until one year. Method of measurement: To calculate the number of skin graft from discharge until one year according to patients file. Mortality due to thermal burn of children. Timepoint: From hospitalization until one year. Method of measurement: The mortality rate ( the proportion of death to number of hospitalized patients) in thermal burn of children. Length of hospital stay. Timepoint: Date of discharge and one year after burn. Method of measurement: Number of hospitalized days. The need to skin graft. Timepoint: From discharge until one year after burn. Method of measurement: The number of skin grafts. Iran University of Medical Sciences Approved 2021-06-12 Research Ethics Committees of Iran University of Medical Sciences Ethics Committees of Iran University of Medical Sciences, Central building of Iran University of Medical Sciences, next to Milad tower, Hemmat highway, Tehran Tehran Tehran Iran (Islamic Republic of)