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IRCT20210712051866N1 IRCT 2022-05-04 Rasht University of Medical Sciences Effect of synbiotic on diabetes control The effect of synbiotic on blood glucose level and HbA1c in children with type 1 diabetes. A parallel, double-blind, randomized clinical trial 2022-05-22 anticipated 86 Complete https://irct.ir/trial/61742 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In order to Randomize the treatment between the groups, Permuted Block Randomization Method with the Size 4, will be used. Considering the Time of Entry into the Study and Considering that A is (Intervention Group) and B is (Placebo Group), A Part of the Random Allocation will be in the Following Order: Randomization will be done with SAS software version 9. Seed: 253569775886591 Block sizes: 4 Actual list length: 86 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 A Assignment of Groups will be performed through Closed Envelopes. The Resident Implementing the Project will register the Participants and the Allocation Sequence will be done by A Statistician through the Relevant Softwares, Blinding description: Researcher and participants are blind in this study (double-blind). The Researcher does not know which participant is in the intervention or control group. The participant does not know whether he/ she is in the intervention or control group. Both groups will receive sachet with the same shape and color with different contents. Intervention and control sachets will be noted as A and B by a pharmacist unaware about the research and will be given to the researcher. 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 same pre-weighed powder form foil packages. Everyday, participants mix one sachet weighing 1 gram with 250ml water and drink it 15-20 mins before the evening meal. For the first 2 weeks, participants are asked to take only half-dose to reduce gastrointestinal side effects, after which they take the full-dose for the remaining 10 weeks. 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 control's group participants in same pre-weighed powder form foil packages. Everyday, participants mix one sachet weighing 1 gram with 250ml water and drink it 15-20 mins before the evening meal. For the first 2 weeks, participants are asked to take only half-dose to reduce gastrointestinal side effects, after which they take the full-dose for the remaining 10 weeks. No - There is not a plan to make this available Justification or reason for not sharing IPD is Regarding to the ethical considerations
public Afagh Hassanzadeh Rad
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 afaghrad@gums.ac.ir Rasht University of Medical Sciences 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 At least 6 Months after the Diagnosis of Diabetes Being Treated with Injectable Insulin Fasting Blod Sugar (FBS) ≥ 126 mg/dl Glocuse, 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 Renal disease Gastrointestinal disease Cardiovascular disease (CVD) Pulmonary disease Taking antibiotics, Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), immunosuppressants during the last month; Taking products containing probiotics and synbiotics or antioxidants in the last month E10.1 Type 1 diabetes mellitus with ketoacidosis Treatment - Other 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 same pre-weighed powder form foil packages. Everyday, participants mix one sachet weighing 1 gram with 250ml water and drink it 15-20 mins before the evening meal. For the first 2 weeks, participants are asked to take only half-dose to reduce gastrointestinal side effects, after which they take the full-dose for the remaining 10 weeks. 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 control's group participants in same pre-weighed powder form foil packages. Everyday, participants mix one sachet weighing 1 gram with 250ml water and drink it 15-20 mins before the evening meal. For the first 2 weeks, participants are asked to take only half-dose to reduce gastrointestinal side effects, after which they take the full-dose for the remaining 10 weeks. Blood glucose level. Timepoint: Blood glucose level measurement 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: BT-3000 chemistry analyzer. Glycated hemoglobin (HbA1c). Timepoint: Glycated hemoglobin (HbA1c) measurement 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: BT-3000 chemistry analyzer. Hypoglycemia incidence. Timepoint: Determining the hypoglycemia incidence at any time of performing the intervention. Method of measurement: Glucometer. Incidence of Diabetic Ketoacidosis (DKA). Timepoint: Determining the Incidence of Diabetic Ketoacidosis (DKA) at any time of performing the intervention. Method of measurement: Ketone bodies level and Arterial Blood Gas. The need for injectable insulin. Timepoint: Determining the need for injectable insulin at any time of performing the intervention. Method of measurement: Based on the patient's blood sugar using a glucometer. The Vice-Chancellor of Research at Guilan University of Medical Sciences Approved 2022-02-23 Ethics Committee of Guilan University of Medical Sciences In front of 17 Shahrivar Hospital, Siadati Ave, Namjou Blvd Rasht Guilan Iran (Islamic Republic of)