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IRCT20131013014994N7 IRCT 2022-04-27 Kermanshah University of Medical Sciences The effect of synbiotic supplementation on plasma levels of Advanced Glycation End Products and cardiovascular risk factors in hemodialysis patients: a double-blind clinical trial The effect of synbiotic supplementation on plasma levels of Advanced Glycation End Products and cardiovascular risk factors in hemodialysis patients: a double-blind clinical trial 2022-05-22 anticipated 34 Complete https://irct.ir/trial/60222 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Eligible participants will be assigned to the two intervention and placebo groups after signing the informed consent form through random blocks of 4 people and in a one-to-one ratio using RAS software. The randomization process is performed by a statistician and patients and researchers will be blinded to the process. Individuals will be matched at the beginning of the study based on diet, sex, age, and duration of dialysis in each block, Blinding description: For this double-blind study, placebo and synbiotic capsules are coded A and B by the supplement provider. The codes are kept in a sealed envelope so that patients and researchers will be blinded by how they are assigned to the supplement or placebo and the study arms until the end of the study. Synbiotic and placebo capsules will be the same size, color, odor and packaging. 3 hemodialysis patients. Intervention 1: During a 12-week intervention in hemodialysis patients, the intervention group received two synbiotic capsules daily, after lunch and dinner. Each synbiotic capsule (under the brand name GeriLact; Bio Fermentation Company, Tehran, Iran) contains Lactobacillus rhamnosus, Lactobacillus casei, lactobacillus acidophilus, Lactobacillus bulgaricus, Lactobacillus fermentum, Lactobacillus plantarus and Lactobacillus plantarum at a dose of 10(9) CFU (10 to the power of 9 CFU) as a probiotic and 21 mg of fructooligosaccharide as a prebiotic. Intervention 2: In patients undergoing hemodialysis in the control group, two placebo capsules daily (Bio Fermentation Company, Tehran, Iran) after lunch and dinner (each capsule contains 350 mg of inulin, maltodextrin and all excipients in the synbiotic product except the active ingredient) Will receive. Synbiotic and placebo capsules will be the same size, color, odor and packaging. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information
public Hadi Abdollahzad
Isaar Square, Faculty of Nutrition Sciences and Food Industry
kermanshah Iran (Islamic Republic of) 6719851552 +98 83 3710 2008 abdollahzad@kums.ac.ir Kermanshah University of Medical Sciences scientific Hadi abdollahzad
Isaar Square, Faculty of Nutrition Sciences and Food Industry
kermanshah Iran (Islamic Republic of) 6719851552 +98 83 3710 2008 abdollahzad@kums.ac.ir Kermanshah University of Medical Sciences Iran (Islamic Republic of) Perform HD treatment at least twice a week for a maximum of 4 hours each time Treatment under HD for at least 6 months No pregnancy or breastfeeding No immune system defects No history of active cancers No history of severe chronic diseases and acute medical conditions such as lung disease, cardiovascular disease, liver disease and acute pancreatitis No addiction to alcohol or drugs Lack of severe digestive disorders and diseases, HIV disease, mental problems Ability to drink at least 200 ml of water per day Life expectancy and survival for at least 3 months Confirmation of written consent no limit no limit Both Patients with severe edema People who had infection 4 weeks ago People who took synbiotics, probiotics, prebiotics, or antibiotics during the 4 weeks before the study Candidates for kidney and organ transplantation or peritoneal dialysis during 3 months of study Taking immunosuppressive drugs or anticoagulants and chemotherapy drugs Sensitivity to complementary compounds The patient's unwillingness to participate in the study Lack of complete answers to questions Report side effects from taking synbiotics R88.0 Cloudy (hemodialysis) (peritoneal) dialysis effluent Treatment - Drugs Placebo During a 12-week intervention in hemodialysis patients, the intervention group received two synbiotic capsules daily, after lunch and dinner. Each synbiotic capsule (under the brand name GeriLact; Bio Fermentation Company, Tehran, Iran) contains Lactobacillus rhamnosus, Lactobacillus casei, lactobacillus acidophilus, Lactobacillus bulgaricus, Lactobacillus fermentum, Lactobacillus plantarus and Lactobacillus plantarum at a dose of 10(9) CFU (10 to the power of 9 CFU) as a probiotic and 21 mg of fructooligosaccharide as a prebiotic.. In patients undergoing hemodialysis in the control group, two placebo capsules daily (Bio Fermentation Company, Tehran, Iran) after lunch and dinner (each capsule contains 350 mg of inulin, maltodextrin and all excipients in the synbiotic product except the active ingredient) Will receive. Synbiotic and placebo capsules will be the same size, color, odor and packaging. Plasma levels of advanced glycation end products in hemodialysis patients. Timepoint: First study (before the intervention) and end of the study (end of week 12). Method of measurement: Blood sample- Advanced Glycation End Products (AGE) ELISA Kit. Plasma homocysteine levels in hemodialysis patients. Timepoint: Beginning of the study (before the intervention) and end of the study (end of week 12). Method of measurement: Blood sample - High performance liquid chromatography. Plasma fibrinogen levels in hemodialysis patients. Timepoint: Beginning of the study (before the intervention) and end of the study (end of week 12). Method of measurement: Blood sample - coagulation factor. Gastrointestinal function. Timepoint: Beginning of the study (before the intervention) and end of the study (end of week 12). Method of measurement: THE GASTROINTESTINAL SYMPTOM RATING SCALE (GSRS). Fasting blood sugar and HgA1C. Timepoint: Beginning of the study (before the intervention) and end of the study (end of week 12). Method of measurement: Blood sample. Kermanshah University of Medical Sciences Approved 2022-04-12 Research Ethics Committee of Kermanshah University of Medical Sciences Shahid Beheshti Boulevard - Central Building of Kermanshah University of Medical Sciences Kermanshah Kermanshah Iran (Islamic Republic of)