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IRCT20201203049576N1 IRCT 2020-12-28 Tehran University of Medical Sciences The effect of probiotics supplementation in type 1 diabetic patients The effect of probiotics supplementation on glycemic control and metabolic parameters in type 1 diabetic patients 2021-01-03 anticipated 64 Complete https://irct.ir/trial/52752 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block Randomization: Block randomization is intended to ensure that exactly the same number of participants enter the intervention and comparison groups at consecutive intervals. For this purpose, the subjects will be divided into double blocks in terms of age, the number of units of injection insulin (maximum 6 units difference), and duration of type 1 diabetes (maximum 3 years difference). Then the people in each block will be divided into intervention and comparison groups. In order to randomly assign individuals to groups, each person is given a code and these codes are poured into a pot. An out-of-study person is then asked to draw the codes out of the pot using a lottery. The first code of each block will be assigned to the intervention group, the second code will be assigned to the comparison group, Blinding description: In this study, participants, researchers, and physicians do not know the type of intervention of placebo capsules or probiotic capsules. In this regard, one code is assigned to the placebo capsule and one code to the probiotic capsule, which is reserved by the manufacturer, and at the end of the study, the intervention and comparison groups will be identified. In this way, two people who are in a block will be given two types of capsules with different codes. Each person will be given capsules with one code and that code will be written first. After the study, the relevant person in charge of the company will be contacted and the code related to the placebo capsules and the code related to the probiotic capsules will be asked and the members of the intervention and comparison group will be identified. Placebo capsules will be no different from supplement capsules in shape, smell, color, and taste. N/A Type 1 diabetes mellitus. Intervention 1: The intervention group will receive a probiotic supplement capsule. This supplement will be produced by the tak gene zist company, which consists of 6 bacterial strains including Lactobacillus acidophilus, Lactobacillus casei, Bacillus coagulans, Bifidobacterium lactis, Bifidobacterium longum, Bifidobacterium Bifidiom [3 × 109 (CFU / gr)] and maltodextrin. This supplement should be taken daily by participants for 12 weeks. Intervention 2: Control group: This group will take the placebo capsule, which contains maltodextrin and does not contain probiotic bacteria, daily for 12 weeks. This capsule will be produced by the tak gene zist company. Yes - There is a plan to make this available What will be shared: Only part of the participants' personal data such as information about the main outcome or the like can be shared. When: Access period starts 8 months after the results are published To whom: The data will be available to researchers working in academic and scientific institutions and to those working in industry. Conditions: No use or analysis of data and documentation is possible for any person. Where to obtain: Dr. Ahmad Esmailzadeh is the supervisor of the project and the data will be preserved with him. If necessary, you can refer to the Faculty of Nutrition and Dietetics of Tehran University of Medical Sciences. How to obtain: The request must be in the form of a letter and stamped by the relevant body or university, and after the necessary checks, the data will be provided to them. Comments:
public Saeedeh Nourimajd
No. 44, Hojjatdoost Alley, Naderi St, Keshavarz Boulevard, Tehran University of Medical Sciences and Health Services, Faculty of Nutrition and Dietetics
Tehran Iran (Islamic Republic of) 1416643931 +98 21 8895 5975 s.nourimajd@gmail.com Tehran University of Medical Sciences scientific Dr. Ahmad Esmaillzadeh
No. 44, Hojjatdoost Alley, Naderi St, Keshavarz Boulevard, Tehran University of Medical Sciences and Health Services, Faculty of Nutrition and Dietetics
Tehran Iran (Islamic Republic of) 1416643931 +98 21 8895 5975 a.esmaillzadeh@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Having type 1 diabetes (fasting blood sugar greater than 125 mg / dL and HbA1C greater than 6.5% if confirmed by an endocrinologist) Age over 7 and under 18 years At least one year after developing type 1 diabetes Willingness to participate in the study 7 years 18 years Both Having liver, kidney, inflammatory, or immunodeficiency diseases Taking antibiotics over the last two months Consuming foods containing probiotics or probiotic supplements over the past month Taking dietary supplements or non-steroid anti-inflammatory drugs during 1 month before the study E10 Type 1 diabetes mellitus Treatment - Drugs Placebo The intervention group will receive a probiotic supplement capsule. This supplement will be produced by the tak gene zist company, which consists of 6 bacterial strains including Lactobacillus acidophilus, Lactobacillus casei, Bacillus coagulans, Bifidobacterium lactis, Bifidobacterium longum, Bifidobacterium Bifidiom [3 × 109 (CFU / gr)] and maltodextrin. This supplement should be taken daily by participants for 12 weeks. Control group: This group will take the placebo capsule, which contains maltodextrin and does not contain probiotic bacteria, daily for 12 weeks. This capsule will be produced by the tak gene zist company Hemoglobin A1c (HbA1C). Timepoint: At the beginning of the study and at the end of the study (after 12 weeks). Method of measurement: Enzymatically using commercial kits. Fasting blood sugar level (FBS). Timepoint: At the beginning of the study and at the end of the study (after 12 weeks). Method of measurement: By glucose oxidase method and using commercial kits. Serum triglyceride levels (TG). Timepoint: At the beginning of the study and at the end of the study (after 12 weeks). Method of measurement: Using glycerol phosphate oxidase and commercial kits. Serum high-density lipoprotein cholesterol level (HDL-C). Timepoint: At the beginning of the study and at the end of the study (after 12 weeks). Method of measurement: HDL-C concentration after deposition of lipoproteins with apo lipoprotein B. Total cholesterol. Timepoint: At the beginning of the study and at the end of the study (after 12 weeks). Method of measurement: By cholesterol oxidase and cholesterol esterase methods and using commercial kits. Serum low-density lipoprotein cholesterol level (LDL-C). Timepoint: At the beginning of the study and at the end of the study (after 12 weeks). Method of measurement: Using the Friedewald formula. Number of units of injection insulin. Timepoint: At the beginning of the study and at the end of the study (after 12 weeks). Method of measurement: Questions and registrations. Blood pressure. Timepoint: At the beginning of the study and at the end of the study (after 12 weeks). Method of measurement: Sphygmomanometer. Anthropometric indicators. Timepoint: At the beginning of the study and at the end of the study (after 12 weeks). Method of measurement: Meters, scales. Tehran University of Medical Sciences Approved 2020-11-30 Ethics committee of Tehran University of Medical Sciences No. 44, Hojjatdoost Alley, Naderi St, Keshavarz Boulevard, Tehran University of Medical Sciences and Health Services, Faculty of Nutrition and Dietetics Tehran Tehran Iran (Islamic Republic of)