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IRCT20220727055564N1 IRCT 2022-08-04 Zahedan University of Medical Sciences Evaluation of Lactocare probiotic effects on the immune system in patients with type II diabetes Evaluation of therapeutic effects of lactocare® probiotic on clinical symptoms, frequency of T cell subsets and expression of HOTAIR and MEG3 genes in patients with type II diabetes in comparison with control group 2022-10-23 anticipated 80 Complete https://irct.ir/trial/65025 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: In this study, the expression level of HOTAIR and MEG3 genes as well as the flow cytometry of T Helper-1, T Helper-2, T Helper-17 and Treg cells before and after the intervention (daily consumption of lactocare probiotic and placebo) will be investigated, Randomization description: Random assignment of patients to two groups will be done by permuted block stratified randomization method. In this way, eligible referring patients are classified according to the age and gender in order of entry. Then, they are assigned to the desired group based on 2-blocks (consisting of two groups A and B) that are randomly selected from among all the possible states of permutations. These blocks were created using R software version 4.0.2, Blinding description: In this research, the double-blind method will be used. So that the participants, the person responsible for providing the drug or placebo and the person responsible for recording the results (laboratory expert) will not be aware of the intervention type. In this trial, the intervention group will receive lactocare probiotic and the control group will receive the placebo, and patients will not be informed to which group they have been assigned. 2 type 2 diabetes. Intervention 1: Intervention group: One capsule of lactocare probiotic, daily for 90 days. Intervention 2: Control group: one capsule of placebo daily for 90 days. Yes - There is a plan to make this available What will be shared: Information about the clinical part of the study is made available to patients after identifying individuals, and other information, including molecular, laboratory, and clinical studies, is provided in detail to academic researchers for further research. Be helpful in this regard. When: The start of the information access period is approximately 4 to 6 months after the publishing the results. To whom: Data from this study are available to participating patients, academic researchers, drug companies, and physicians. Conditions: It is explained to the patients that if the information obtained from this study is aimed at improving the clinical conditions, it should not be suggested to other patients to takelactocare probiotic medicine because the study is conducted with special criteria and under the supervision of pharmacology and immunology experts and doctors. Internal specialist or endocrinology subspecialist is designed. For academic researchers in order to obtain more information in this field, for example, they can have more maneuver in their future research on the number of samples, the duration of the trial, the dosage of lactocare probiotic drug, and even design stronger studies by using molecular information and methods. do Also, the study information may be useful for the drug manufacturing company to improve the quality of the drug. Where to obtain: To obtain patient information, please refer to Dr. Mehdi Atabaki, Ph.D. in Immunology at Bo Ali Zahedan Hospital. Address: Shariati St., Shohada Square, Bu Ali Hospital with zip code: 9816743111 Phone: +98 930 304 3900 Access to other information will be possible by requesting via email to atabaki80@gmail.com. How to obtain: Study information 6 months after the publication of all domestic and foreign articles and receiving complete information from researchers who intend to do research in this field, the information will be provided to them in time frames and according to the preservation of the law of copying and pasting. Comments:
public Mahdi Atabaki
Daneshgah Street
Zahedan Iran (Islamic Republic of) 9816743463 +98 54 3337 2151 atabaki80@gmail.com Zahedan University of Medical Sciences scientific Mahdi Atabaki
Daneshgah street
Zahedan Iran (Islamic Republic of) 9816743463 +98 54 3337 2151 atabaki80@gmail.com Zahedan University of Medical Sciences Iran (Islamic Republic of) Having a willingness and informed consent to participate in the study Having clinical symptoms of type 2 diabetes Confirmation of type 2 diabetes based on clinical symptoms and diagnostic tests by a specialist doctor No recent history of inflammatory diseases No history of receiving anti-inflammatory drugs No history of taking corticosteroid drugs Absence of immune system diseases and immune deficiencies no limit no limit Both History of heart diseases including: blood pressure, heart failure, heart attack in the last month History of autoimmune diseases including: type 1 diabetes, multiple sclerosis, MS, lupus erythematosus, various types of vasculitis, rheumatism, Crohn's disease, etc. History of liver diseases including: liver cirrhosis and hepatitis in the past year History of underlying lung diseases such as: asthma, bronchiolitis, respiratory allergies, bronchiectasis, COPD History of organ transplant in the last three months People with a history of alcohol consumption Taking immunosuppressive drugs E11.9 Type 2 diabetes without complications Treatment - Drugs Placebo Intervention group: One capsule of lactocare probiotic, daily for 90 days Control group: one capsule of placebo daily for 90 days Frequency of T helper 1 cell population. Timepoint: Measuring the frequency of T helper 1 cells at the beginning of the study (before the start of the intervention) and 3 months after the start of lactocare probiotic or placebo. Method of measurement: T Helper 1 is the main cell in inflammatory responses and produces interferon-gamma, which is measured by flow cytometry. Frequency of T helper 2 cell population. Timepoint: Measuring the frequency of T helper2 cells at the beginning of the study (before the start of the intervention) and 3 months after the start of lactocare probiotic or placebo. Method of measurement: T helper 2 is the main cell in the protection of inflammatory responses and the producer of interleukin 4, which is measured by flow cytometry. Frequency of T helper cell population 17. Timepoint: Measuring the frequency of T helper 17 cells at the beginning of the study (before the start of the intervention) and 3 months after the start of lactocare probiotic or placebo. Method of measurement: T Helper 17 is a cell effective in inflammatory responses and produces interleukin 17, which is measured by flow cytometry. Frequency of regulatory T cell population. Timepoint: Measurement of the frequency of regulatory T cells at the beginning of the study (before the start of the intervention) and 3 months after the start of lactocare probiotic or placebo. Method of measurement: Regulatory T, a cell effective in protecting inflammatory responses, with foxp3 factor measured by flow cytometry. Maternal expressed gene 3 (lnc-MEG3). Timepoint: Measurement of the lnc-MEG3 gene expression level at the beginning of the study (before the start of the intervention) and 3 months after the start of taking lactocare probiotic drug or placebo. Method of measurement: Investigating the expression level of lnc-MEG3, which is an LncRNA that affects the functions of the immune system, compared to U6 small nuclear 1 is measured by real time PCR method. Gene Expression (lnc-HOTAIR) HOX Transcript Antisense RNA. Timepoint: Measurement of the lnc-HOTAIR gene expression level at the beginning of the study (before the start of the intervention) and 3 months after the start of taking lactocare probiotic drug or placebo. Method of measurement: Investigating the level of expression of lnc-HOTAIR, which is an LncRNA that affects the functions of the immune system, compared to U6 small nuclear 1, is measured by real time PCR method. FBS( fasting blood glucose). Timepoint: Measurement of FBS amount at the beginning of the study (before the start of the intervention) and 3 months after the start of taking lactocare probiotic drug or placebo. Method of measurement: Fasting blood glucose measured by the glucose oxidase/peroxidase method. Triglyceride (TG). Timepoint: Measuring the amount of triglycerides at the beginning of the study (before the start of the intervention) and 3 months after the start of taking lactocare probiotic drug or placebo. Method of measurement: Triglyceride is a form of fat storage in the blood circulation that is measured by an enzyme method. Cholesterol (CHOL). Timepoint: Cholesterol measurement at the beginning of the study (before the start of the intervention) and 3 months after the start of lactocare probiotic drug or placebo. Method of measurement: Total cholesterol in LDL, VLDL and HDL particles in blood circulation, which is measured by enzyme method. High-density lipoprotein (HDL-c). Timepoint: HDL measurement at the beginning of the study (before the intervention) and 3 months after the start of lactocare probiotic drug or placebo. Method of measurement: Cholesterol contained in HDL particles in the circulation, which is measured by an enzymatic method. Low-density lipoprotein (LDL-c). Timepoint: Measuring the amount of LDL at the beginning of the study (before the start of the intervention) and 3 months after the start of taking lactocare probiotic or placebo. Method of measurement: Cholesterol contained in LDL particles in the blood circulation, which is measured by an enzymatic method. Clinical symptoms of patients with type 2 diabetes mellitus in the studied groups. Timepoint: The clinical symptoms of patients with type 2 diabetes will be measured at the beginning of the study (before the intervention) and 90 days after the start of lactocare probiotic medicine. Method of measurement: The clinical symptoms of type 2 diabetes patients will be measured by examining nutrition (in terms of consumption or non-consumption of probiotic products), culture (having or not having eating and social habits) by an internal medicine specialist or an endocrinologist. Zahedan University of Medical Sciences Approved 2022-07-27 Ethics Committee of Zahedan University of Medical Sciences Campus of Zahedan University of Medical Sciences, Dr. Hesabi Square, Zahedan, Iran Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)