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IRCT20121028011288N15 IRCT 2018-06-27 Tabriz University of Medical Sciences The Effects of Lactobacillus rhamnosus in patients with Myocardial Infarction (MI) Effects of Lactobacillus rhamnosus supplementation on inflammatory and oxidative biomarkers, gut microbiota profile, gut metabolites and cardiac remodeling in patients with Myocardial Infarction (MI) 2018-06-10 anticipated 44 Complete https://irct.ir/trial/30121 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The eligible participants will be randomly allocated to intervention and placebo groups using a software generated random permuted blocks. The generated random sequence will be kept in a protected location and administered by an independent third party who is blind to the trial throughout the study, Blinding description: In this double-blind study, no patient and investigator will be aware of the treatment assignments for the duration of the study. For blinding the trial, the Lactobacillus rhamnosus capsules and placebo, will be identical in appearance, packaging, and labeling. All capsules will be packed and encoded by the company (Takgene Company). 3 Myocardial Infarction (MI). Intervention 1: Intervention group: Patients in this group will receive probiotic capsule for 12 weeks. Probiotic capsule is a containing 1.6× 109 CFU of lactobacillus rhamnosus (a product by TacZist Co. and made in The Iran) and used once a day with lunch. Intervention 2: Control group:Patients in this group will receive maltodextrin capsules for 12 weeks which are same size and shape ( product by TacZist Co. and made in The Iran) and used once a day with lunch. Yes - There is a plan to make this available What will be shared: Data collected for the primary outcomes will be shared. When: Accessibility to data is possible 8 months after publication. To whom: The data will only be available for people working in academic institutions. Conditions: The data of the present study will only be accessible by other researchers, for conducting Meta analysis. Where to obtain: 1. Dr. Mohammad Alizadeh, Faculty of Nutrition and Food Sciences, Tabriz University of Medical Sciences, +989141894102, mdalizadeh@tbzmed.ac.ir 2. Jalal Moludi, Faculty of Nutrition and Food Sciences, Tabriz University of Medical Sciences, +989399516760, jmoludi@yahoo.com How to obtain: The applicator can send a request to the person responsible for the study by email and within 10 days the document will be sent to the requesting person. Comments:
public Jalal Moludi
Golgasht street, Tabriz university of medical sciences
Tabriz Iran (Islamic Republic of) 5166614711 +98 41 3381 1902 jmoludi@yahoo.com Tabriz University of Medical Sciences scientific Dr. Mohammad Alizadeh
Golgasht street, Tabriz university of medical sciences
Tabriz Iran (Islamic Republic of) 5166614711 +98 41 3335 7581 mdalizadeh@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Patients with Myocardial Infarction and successful precancerous intervention (PCI) age range from 30-60 years body mass index (BMI) higher than 25 kg/m2 will be included in the study. 30 years 60 years Both patient with chronic renal failure; hemodialysis previous myocardial infraction patients receiving immunosuppressive, anti-inflammatory and corticosteroid drugs; history of supplementation with pre/pro/symbiotic or antioxidants during previous two months will not be included in the study. with Being irritable bowel syndrome; Crohn's disease or ulcerative colitis Heart failure (functionclass III and IV), Heart valve diseases Subjects with diabetes I21 ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction Treatment - Drugs Placebo Intervention group: Patients in this group will receive probiotic capsule for 12 weeks. Probiotic capsule is a containing 1.6× 109 CFU of lactobacillus rhamnosus (a product by TacZist Co. and made in The Iran) and used once a day with lunch. Control group:Patients in this group will receive maltodextrin capsules for 12 weeks which are same size and shape ( product by TacZist Co. and made in The Iran) and used once a day with lunch. Depression severity. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Beck Depression Inventory scale. Physical activity level. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Via IPAQ questionnaire. Quality of life. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Via MacNew questionnaire. Lipid profile including HDL, LDL, TC and TG. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: HDL, TC and TG via enzymatic kit, LDL via friedewald equation. Serum levels of Gut metabolites (TLR4, Zonulin and LPS). Timepoint: Baseline and 12 weeks after intervention. Method of measurement: TLR4, Zonulin and LPS measurements by ELISA. Oxidative stress indices. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Measurement of serum levels of Total antioxidant capacity (TAC) and malondialdehyde (MDA) by spectrophotometry. Serum level of Gut metabolite ( TMAO). Timepoint: Baseline and 12 weeks after intervention. Method of measurement: TMAO level by MS / MS. Inflammatory stress indices. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Measurement of inflammatory indices of hs-CRP, IL1B and IL-10 in serum by ELISA. Level of ox-LDL. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Measurement of ox-LDL via ELISA kit. Levels of TGF. Beta. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Measurement of TGF. Beta via ELISA kit. Levels of NTpro BNP. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Measurement of NTpro BNP via ELISA kit. Levels of MMP-9. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Measurement of NTpro BNP via ELISA kit. Levels of Procolagen I. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Measurement of Procolagen I via ELISA kit. Echocardiographic indices of cardiac remodeling including left ventricular end diastolic diameter (LVEDD), right ventricular end diastolic diameter (RVEDD), left ventricular end-diastolic volume (LVEDV), right ventricular end-diastolic volume (RVEDV) and Ejection Fraction ( EF). Timepoint: Baseline and 12 weeks after intervention. Method of measurement: 3-Dimentional Echocardiography. Dietary inflammatory index (DII ). Timepoint: At the beginning of the study and 12 weeks later. Method of measurement: via Food Frequency Questionnaire. Tabriz University of Medical Sciences Approved 2018-05-21 Ethics Committee of Tabriz University of Medical Sciences Tabriz University of Medical Sciences, Attar Neyshabouri Av., Golgasht St. Tabriz East Azarbaijan Iran (Islamic Republic of)