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IRCT20220313054269N1 IRCT 2022-05-24 Islamic Azad University, Science and Research Branch Effect of synbiotic in treatment of diabetes The effect of combination therapy with insulin and synbiotic on platelet indices in children with type 1 diabetes 2022-05-28 anticipated 76 Complete https://irct.ir/trial/63186 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: To randomize the treatment between two groups, Permuted Block Randomization Method with the Size 4, will be used. Considering the time of patients entry into the study and that A is (Intervention group) and B is (Control group), A Part of the Random Allocation will be as follows: Randomization is done with SAS software version 9. Seed: 253569775886591 Block sizes: 4 Actual list length: 76 block identifier, block size, sequence within block, treatment • 1, 4, 1, Group B • 1, 4, 2, Group A • 1, 4, 3, Group B • 1, 4, 4, Group A • 2, 4, 1, Group B • 2, 4, 2, Group A • 2, 4, 3, Group B • 2, 4, 4, Group A Groups assignment will be performed by the closed envelopes. The researcher registers the participants and the statistician determines the allocation sequence using the relevant softwares, Blinding description: In this double-blind, randomized, clinical trial, blinding will be performed for the researcher (outcome assessor) and the participants. The researcher (outcome assessor) doesn't know which participant is in the intervention or control group and the participants don't know which group they are in. 3 Type 1 diabetes. Intervention 1: Intervention group: Synbiotic (Kidilact sachet of Zist-Takhmir company with the power of 10^9 CFU, containing Lactobacillus rhamnosus, Lactobacillus reuteri, Lactobacillus acidophilus, Lactobacillus bulgaricus, Lactobacillus casei, Bifidobacterium infantis, Bifidobacterium breve, Bifidobacterium bifidum, Bifidobacterium lactis, Sterptococcus thermophilus Suchets and Fructooligosaccharide) is given to the intervention's group participants in the same 1 gram powder form sachets. Everyday, participants mix one sachet weighing 1 gram with 250ml water and drink it 15-20 mins before the evening meal. Intervention 2: Control group: Placebo (Product of Zist-Takhmir company, Containing Lactose monohydrate 80 Mesh, Inulin, Talc, Magnesium stearate, Colloidal silicon dioxide, Sucralose, Corn flour and Xanthan gum) is given to the intervention's group participants in the same 1 gram powder form sachets. Everyday, participants mix one sachet weighing 1 gram with 250ml water and drink it 15-20 mins before the evening meal. No - There is not a plan to make this available Justification or reason for not sharing IPD is Confidentiality of patients information
public Sara Sarrafizadeh
Science and Research Branch, Daneshgah Square, Simon Bulivar Blvd, Ashrafi Esfahani Expy
Tehran Iran (Islamic Republic of) 1477893855 +98 21 4486 7161 sara.sarrafi@gmail.com Islamic Azad University, Science and Research Branch scientific Setila Dalili
17 Shahrivar Educational, Therapeutic and Research Center, South of the City Park, Siadati Ave, Namjou Blvd
Rasht Iran (Islamic Republic of) 4144654379 +98 13 3336 9019 setiladalili1346@yahoo.com Rasht University of Medical Sciences Iran (Islamic Republic of) Girls and Boys 4-18 Years Being Treated with Injectable Insulin Fasting Blood Sugar (FBS) ≥ 126 mg/dl Glucose, 2 hour Post Prandial (2hpp) ≥ 200 mg/dl Glycated Hemoglobin (HbA1c) ≥ 6.5% Blood Sugar (BS) ≥ 200 mg/dl Along with Polydipsia and Polyuria 4 years 18 years Both Taking antibiotics, Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), immunosuppressants during the last month Taking products containing probiotics and synbiotics in the last month Metabolic disease Gastrointestinal disease Cardiovascular disease (CVD) Renal disease E10.9 Type 1 diabetes mellitus without complications Treatment - Drugs Placebo Intervention group: Synbiotic (Kidilact sachet of Zist-Takhmir company with the power of 10^9 CFU, containing Lactobacillus rhamnosus, Lactobacillus reuteri, Lactobacillus acidophilus, Lactobacillus bulgaricus, Lactobacillus casei, Bifidobacterium infantis, Bifidobacterium breve, Bifidobacterium bifidum, Bifidobacterium lactis, Sterptococcus thermophilus Suchets and Fructooligosaccharide) is given to the intervention's group participants in the same 1 gram powder form sachets. Everyday, participants mix one sachet weighing 1 gram with 250ml water and drink it 15-20 mins before the evening meal. Control group: Placebo (Product of Zist-Takhmir company, Containing Lactose monohydrate 80 Mesh, Inulin, Talc, Magnesium stearate, Colloidal silicon dioxide, Sucralose, Corn flour and Xanthan gum) is given to the intervention's group participants in the same 1 gram powder form sachets. Everyday, participants mix one sachet weighing 1 gram with 250ml water and drink it 15-20 mins before the evening meal. Blood Platelet Count (PLT). Timepoint: Blood Platelet counting at the beginning of the intervention (Before the start of the intervention) and 12 weeks after the start of synbiotic and/or placebo usage. Method of measurement: Sysmex XS800 hematology analyzer. Platelet Percentage (PCT). Timepoint: Platelet Percentage calculating at the beginning of the intervention (Before the start of the intervention) and 12 weeks after the start of synbiotic and/or placebo usage. Method of measurement: Sysmex XS800 hematology analyzer. Mean Platelet Volume (MPV). Timepoint: Mean Platelet Volume calculating at the beginning of the intervention (Before the start of the intervention) and 12 weeks after the start of synbiotic and/or placebo usage. Method of measurement: Sysmex XS800 hematology analyzer. Platelet Distribution Width (PDW). Timepoint: Platelet Distribution Width calculating at the beginning of the intervention (Before the start of the intervention) and 12 weeks after the start of synbiotic and/or placebo usage. Method of measurement: Sysmex XS800 hematology analyzer. Vice-Chancellor for Research & Technology, Islamic Azad University, Science and Research Branch Approved 2021-11-02 Ethics committee of Islamic Azad University, Science and Research Branch Science and Research Branch, Daneshgah Square, Simon Bulivar Blvd, Ashrafi Esfahani Expy Tehran Tehran Iran (Islamic Republic of)