]>
IRCT20230701058626N1 IRCT 2023-11-30 Shiraz University of Medical Sciences investigating the effect of probiotic supplements on blood pressure changes in patients undergoing hemodialysis at Namazi Hospital in Shiraz. Randomized clinical trial investigating the effect of probiotic supplements on blood pressure changes in patients undergoing hemodialysis Randomized clinical trial 2023-12-12 anticipated 152 Complete https://irct.ir/trial/73836 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization method will be done using the permutation blocks method using the site www.sealedenvelop.com based on 38 random blocks of size 4 for the calculated sample size of 152 people, and the random sequence generated is prepared in the EXCEL file, Blinding description: Medicines and placebo are given to the nurses of the dialysis department in completely similar packages (marked with numbers one to four) based on block randomization, and they are not aware of the contents of the packages. Based on the numbers and list of patients, he distributes medicines and placebo to the patients, and the patients do not know about the contents of the packages. The analyzer knows the contents of the packets. N/A Hemodialysis patients. Intervention 1: Sachet containing probiotic L-Plantarum with a dose of 1*109, to be taken orally one sachet daily for 12 weeks. Intervention 2: A sachet containing the probiotic Streptococcus thermophilus with a dose of 1*109 to be taken orally once a day for 12 weeks. Intervention 3: A sachet containing a combination of two probiotics, L. plantarum and Streptococcus thermophilus, with a dose of 2*109, which should be taken orally for 12 weeks. Intervention 4: Control group: placebo. Yes - There is a plan to make this available What will be shared: Information on the effects of probiotics on blood pressure values in dialysis patients will be shared When: After publication of the article To whom: All researchers Conditions: For guidance for research in this field and in the form of general results Where to obtain: The corresponding author of the article - Shiraz Nephro- urology l Research Center How to obtain: The corresponding author of the article - Shiraz Nephro- urology l Research Center Comments:
public Zeinab Karimi
Shiraz, Khalili Street, Mohammad Rasoolullah Research Tower
Shiraz Iran (Islamic Republic of) 7193635899 0098 71 3612261 zkarimi@sums.ac.ir Shiraz University of Medical Sciences scientific Zeinab Karimi
Shiraz, Khalili Street, Mohammad Rasulullah Research Tower
Shiraz Iran (Islamic Republic of) 7193635899 +98 71 3612 2261 zkarimi@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Patients with chronic kidney disease who undergo hemodialysis for more than three months are included in the study 18 years 70 years Both Active cancer Active infection Pregnancy Sensitivity to probiotic compounds Z99.2 Dependence on renal dialysis Treatment - Drugs Treatment - Drugs Treatment - Drugs Placebo Sachet containing probiotic L-Plantarum with a dose of 1*109, to be taken orally one sachet daily for 12 weeks. A sachet containing the probiotic Streptococcus thermophilus with a dose of 1*109 to be taken orally once a day for 12 weeks. A sachet containing a combination of two probiotics, L. plantarum and Streptococcus thermophilus, with a dose of 2*109, which should be taken orally for 12 weeks. Control group: placebo Arterial blood pressure. Timepoint: before and after treatment. Method of measurement: Arterial blood pressure of patients undergoing dialysis is taken and recorded in three stages before, during and after dialysis. 1. Determining the average arterial blood pressure before, during, and after receiving probiotics and placebo in experimental groups. Timepoint: before, during, and after receiving probiotics and placebo. Method of measurement: Digital pressure gauge. Determining the average angiotensin-converting enzyme (ACE) activity before and after receiving probiotics and placebo in experimental groups. Timepoint: before and after receiving probiotics and placebo. Method of measurement: Spectrophotometry. Determining the average total antioxidative capacity (TAC), and total oxidative state (TOS) measure before and after receiving probiotics and placebo in experimental groups. Timepoint: before and after receiving probiotics and placebo. Method of measurement: Spectrophotometry. Determining the average complete blood count (CBC) before and after receiving probiotics and placebo in experimental groups. Timepoint: before and after receiving probiotics and placebo. Method of measurement: Autolyzer. Shiraz University of Medical Sciences Approved 2023-11-12 Ethics committee of Shiraz University of Medical Sciences Shiraz, Zand Street, in front of Palestine Street, central building of Shiraz University of Medical Sciences Shiraz Fars Iran (Islamic Republic of)