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IRCT20170609034406N4 IRCT 2020-02-07 Tabriz University of Medical Sciences The effect of probiotic on uremic toxins and quality of life in chronic hemodialysis patients The effect of probiotic (Saccharomycesboulardi) on uremic toxins and quality of life in patients with chronic hemodialysis. 2019-04-03 anticipated 60 Complete https://irct.ir/trial/37957 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Supportive. 2 hemodialysis patients. Intervention group: The treatment group consists of 60 patients receiving Daily Yeast 500 mg produced by Zist takhmir factory, once daily for 4 months. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Afshin Gharekhani
Faculty of pharmacy-Tabriz university of medical science-Golgasht Avenue
Tabriz Iran (Islamic Republic of) 5147663419 +98 41 3335 5921 gharekhania@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Afshin Gharekhani
Faculty of pharmacy-Tabriz university of medical science-Daneshgah avenue-Golgasht
Tabriz Iran (Islamic Republic of) 5147663419 +98 41 3230 5153 gharekhania@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Age over 18 years Begining of hemodialysis from previous 3 months for three times a week Ability to understand and sign a consent form Use of biocompatible dialysis membrane Properly functioning arteriovenous fistula or catheter 18 years no limit Both Pregnancy and lactation Use of broad-spectrum antibiotics in the last 3 months or now Allergy to probiotics The presence of any chronic, active, uncontrolled or severe chronic inflammatory disease (autoimmune diseases, connective tissue disease, malignancy, HIV, liver disease and pulmonary disease) The presence of chronic or acute infection in a recent month Concurrently presence in another trial (drug or supplement) A history of stroke or myocardial infarction in the last 3 months Receiving medications which are effective on inflammatory factors (corticosteroids or other immunosuppressive drugs, nonsteroidal anti-inflammatory drugs, contraceptives, pentoxifylline) Z49.01 Extracorporeal dialysis Treatment - Drugs Intervention group: The treatment group consists of 60 patients receiving Daily Yeast 500 mg produced by Zist takhmir factory, once daily for 4 months Serum level of Indoxyl Sulphate. Timepoint: Before intervention-At the end of intervention. Method of measurement: ELISA kit. Serum level of P-cresyl sulphate. Timepoint: Before intervention-At the end of intervention. Method of measurement: ELISA kit. Serum level of P-cresol. Timepoint: Before intervention-At the end of intervention. Method of measurement: ELISA kit. Quality of life. Timepoint: Before intervention-At the end of intervention. Method of measurement: Short form (36) quality of life survey. Tabriz University of Medical Sciences Approved 2019-01-07 Ethics Committee of Tabriz University of Medical Sciences Center of Research and Technology, No 2 Central Building , Tabriz University of Medical Sciences , Golgasht Street Tabriz East Azarbaijan Iran (Islamic Republic of)