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IRCT20091114002709N55 IRCT 2020-11-04 Iran University of Medical Sciences The effect of synbiotic use on heart failure The effect of synbiotic consumption on serum paraoxonase 1(PON1), Soluble CD163/Soluble TNF-like weak inducer of apoptosis(sCD163/sTWEAK) and lipid profile in patients with chronic heart failure 2020-08-13 anticipated 90 Complete https://irct.ir/trial/50073 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization is done in the form of random blocks of volume 4 and the random list is compiled by statistical software. Randomization and blinding of the study are performed to maintain concealment. In case of deviation from the protocol, the data is analyzed by the Intention to Treat (ITT) method , so that statistical analysis of clinical trials of data obtained from participants at the end will be performed using randomization that was randomized at the beginning of the study, Blinding description: Study subjects and researchers will be blinded to the intervention. Synbiotics and placebo capsules are similar in appearance, odor, weight and packaging and only the code on the package (A or B) is different. 3 Chronic heart failure. Intervention 1: Intervention group: Patients will be given 1 capsule of lactocare synbiotic daily for 10 weeks. Lactocare Synbiotic Capsules are manufactured by Zist Takhmir Company .Lactocare is an oral capsule containing high levels of beneficial bacteria (Lactobacilli, Bifidobacteria and Streptococcus) with prebiotic fructo-oligosaccharide (contributing to growth and probiotic activity). Intervention 2: Control group: Patients consume one placebo capsule daily for 3 weeks. Placebo capsules Are produced by Zist Takhmir company. Yes - There is a plan to make this available What will be shared: Some of the data will be shared, such as information about the main consequences and etc. When: The access period will be 6 months after publication of the results To whom: The obtained data from current study will be available only for researchers working in academic and scientific institutions. Conditions: Six months after the publication of the papers from this study, the data obtained will be available to the applicant researchers for further analysis. Where to obtain: Applicants can be contacted with correspond author by e-mail or postal address to receive the requested data. Postal address: Nutrition department, School of health, Iran University of Medical Sciences, Hemmat expressway, Tehran Phon number:0098 21 8862 2755 E-mail: Farzadshidfar@yahoo.com How to obtain: Applicants will be able to access the obtained data from current study by sending an email to the corresponding author, after a maximum of one week. Comments:
public Dr.Farzad Shidfar
School of health, Iran university of medical science, Shahid Hemmat highway
Tehran Iran (Islamic Republic of) 1449614535 +98 21 8862 2755 Shidfar.f@iums.ac.ir Iran University of Medical Sciences scientific Dr.Farzad Shidfar
School of health, Iran university of medical science, Shahid Hemmat highway
Tehran Iran (Islamic Republic of) 1449614535 +98 21 8862 2755 Shidfar.f@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Age range from 30 to 70 yearsPatients with systolic heart failure (LVEF <40%) approved by a cardiologist and receiving at least 3 months of standard heart failure treatment , Medications have reached the maximum tolerated dose and their medication dose will remain constant throughout the study.class 1,2 and 3 of NYHA classificationWillingness to participate in the study and sign informed written consentLack of other diseases including chronic and acute liver disorders (hepatitis B, C, etc.), diabetes, thyroid disorders, severe renal dysfunction (300 mmol /l ≤ creatinine ), pulmonary diseases, inflammatory and autoimmune diseases, Cancer, acute infectionNot using any nutritional supplements for the past two months.No substance abuse and smokingNot taking Corticosteroids in the past 4 weeksFailure to receive antibiotics in the past 3 monthsNo history of gastrointestinal surgeryNo anti-inflammatory drugs except low-dose aspirin (one 80 mg daily)No artificial heart valveNo history of rheumatic heart diseaseNot being pregnant and breastfeedingLack of insulin BMI< 30 30 years 70 years Both Not willing to continue cooperationuse of less than 80% of supplements given to the patient during the study period Acceptance rate = The number of capsules given to the patient - the Number of capsules not used / The number of capsules given to the patientother disease such as metabolic diseases,Cancer and inflammatory diseases during the study that Need special treatment or antibiotic use.Changes in the type and dose of drug which is using by the patient . I50.9 Cardiac, heart or myocardial failure NOS Treatment - Drugs Placebo Intervention group: Patients will be given 1 capsule of lactocare synbiotic daily for 10 weeks. Lactocare Synbiotic Capsules are manufactured by Zist Takhmir Company .Lactocare is an oral capsule containing high levels of beneficial bacteria (Lactobacilli, Bifidobacteria and Streptococcus) with prebiotic fructo-oligosaccharide (contributing to growth and probiotic activity) Control group: Patients consume one placebo capsule daily for 3 weeks. Placebo capsules Are produced by Zist Takhmir company. SCD163 to sTWEAK ration. Timepoint: Before intervention and 10 weeks after the start of intervention. Method of measurement: ELISA kit. Paraoxonase 1. Timepoint: Before intervention and 10 weeks after the start of intervention. Method of measurement: ELISA kit. Triglyceride. Timepoint: Before intervention and 10 weeks after the start of intervention. Method of measurement: colorimetri. Total cholestrol. Timepoint: Before intervention and 10 weeks after the start of intervention. Method of measurement: colorimetri. LDL-c. Timepoint: Before intervention and 10 weeks after the start of intervention. Method of measurement: colorimetri. HDL-C. Timepoint: Before intervention and 10 weeks after the start of intervention. Method of measurement: colorimetri. Iran University of Medical Sciences Approved 2020-10-26 Ethics committee of Iran University of Medical Sciences Hemat Express way, Iran University of Medical Sciences Tehran Tehran Iran (Islamic Republic of) Approved 2019-05-03 Ethics committee of Iran University of Medical Sciences Hemat Express way, Iran University of Medical Sciences Tehran Tehran Iran (Islamic Republic of) Approved 2020-03-03 Ethics committee of Iran University of Medical Sciences Hemat Express way, Iran University of Medical Sciences Tehran Tehran Iran (Islamic Republic of)