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IRCT20250609066136N1 IRCT 2025-08-12 Shahid Beheshti University of Medical Sciences effect of probiotic supplementation in transplant patients Investigating the effect of probiotic supplementation on progression of Carotid intima-media thickness after kidney transplantation, a triple blinded clinical trial study 2025-09-23 anticipated 60 Recruiting https://irct.ir/trial/85434 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: The study population will be completely randomly divided into 2 groups three months after the transplant and when kidney function has stabilized based on the physician's diagnosis. Randomization will be performed using a stratified blocked randomization method based on gender and age as the blocks. Blocks will be considered as 4, Blinding description: The study will be conducted in a triple-blind manner, so that the main investigator, the study population, and the results analyst will not be aware of the type of randomization in the groups and the type of intervention. The company producing the probiotic and placebo will send the product to the researcher in a coded form, and the researcher will not be aware of the coding until the end of the analysis. When the results are analyzed, the codes will be announced by the company and it will be clear what type of intervention each person received. N/A Condition 1: kidney transplant. Condition 2: Atherosclerosis. Intervention 1: Intervention group: Will receive one probiotic supplement daily produced by Zist Tahmir Company. This supplement contains the following bacterial strains: Lactobacillus rhamnosus Lactobacillus plantarum Lactobacillus casei Lactobacillus helveticus Lactobacillus acidophilus Lactobacillus bulgaricus 109CFU Blend Lactobacillus gasseri Bifidobacterium bifidum Bifidobacterium lactis Bifidobacterium breve Bifidobacterium longum Streptococcus thermophile .Carotid intima-media thickness will be measured before the intervention and at the end of three months of probiotic consumption using Doppler ultrasound. Participants will be excluded from the study if they do not tolerate the probiotic. Intervention 2: Control group: will receive one placebo produced by Zist Takhimr Company daily. Carotid intima-media thickness will be measured before the intervention and at the end of three months of probiotic consumption using Doppler ultrasound. Participants will be excluded from the study if they do not tolerate the probiotic. Yes - There is a plan to make this available What will be shared: Information related to the main outcome can be shared. When: Access period starts one month after the result publication. To whom: people working in academic institutions Conditions: Data integration with other sources is only permitted with the approval of the ethics committee. Only analyses that do not result in re-identification of individuals are permitted. Where to obtain: Vice-Chancellor for Research and Technology, Shahid Beheshti University of Medical Sciences, Velenjak, Arabi St., Tehran, Postal Code 4631-19395 How to obtain: Request to Vice President for Research and Technology, Shahid Beheshti University of Medical Sciences Comments:
public Somaye-Sadat Heidari
Research Institute for Urology and  Nephrology, No. 103, 9th Boostan St, Pasdaran St
Tehran Iran (Islamic Republic of) 1666668111 +98 21 2259 4197 somayesadat_heidary@yahoo.com Shahid Beheshti University of Medical Sciences scientific Somaye_Sadat Heidari
Research Institute for Urology and  Nephrology, No. 103, 9th Boostan St, Pasdaran St
Tehran Iran (Islamic Republic of) 1666668111 +98 21 2256 4197 somayesadat_heidary@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) First kidney transplant at least three months after transplantation no impairment in allograft function prior to study entry 18 years 65 years Both Multiple transplants graft loss during the first three months hepatitis smoking, diabetes pregnancy history of cardiovascular diseasث graft rejection before and after study malignancy liver cirrhosis Z94.0 I65.2 Kidney transplant status Occlusion and stenosis of carotid artery Other Placebo Intervention group: Will receive one probiotic supplement daily produced by Zist Tahmir Company. This supplement contains the following bacterial strains: Lactobacillus rhamnosus Lactobacillus plantarum Lactobacillus casei Lactobacillus helveticus Lactobacillus acidophilus Lactobacillus bulgaricus 109CFU Blend Lactobacillus gasseri Bifidobacterium bifidum Bifidobacterium lactis Bifidobacterium breve Bifidobacterium longum Streptococcus thermophile .Carotid intima-media thickness will be measured before the intervention and at the end of three months of probiotic consumption using Doppler ultrasound. Participants will be excluded from the study if they do not tolerate the probiotic. Control group: will receive one placebo produced by Zist Takhimr Company daily. Carotid intima-media thickness will be measured before the intervention and at the end of three months of probiotic consumption using Doppler ultrasound. Participants will be excluded from the study if they do not tolerate the probiotic. Intima- media carotid thickness. Timepoint: before and 3 months after intervention initiation. Method of measurement: Doppler sonography. Shahid Beheshti University of Medical Sciences Approved 2024-03-07 Research Ethics committee of Urology and Nephrology Research center, Shahid Beheshti University of M Shahid Beheshti University of Medical Sciences, Arabi St, Velenjak Tehran Tehran Iran (Islamic Republic of)