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IRCT20201005048927N1 IRCT 2025-04-27 Shiraz University of Medical Sciences Investigating the effect of probiotic supplements on uremic pruritus in patients undergoing hemodialysis. Investigating the effect of Streptococcus thermophilus, Lactiplantibacillus plantarum and the combination of these two probiotics on uremic pruritus in patients undergoing hemodialysis : A double-blind randomized clinical trial 2025-03-21 anticipated 56 Complete https://irct.ir/trial/82905 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Initially, block randomization will be conducted. Grouping of patients will be carried out in a double-blind manner. The drugs and placebo will be provided to the dialysis unit nurse in similar packaging (labeled with numbers one to four) based on block randomization, and they will not be aware of the contents of the packages. Based on the numbers and the patient list, they will distribute the drugs and placebo among the patients, who will also be unaware of the contents of the packages. On the other hand, data collection will be performed by another researcher who has not been involved in the patient allocation process from the beginning and is unaware of it, Blinding description: Participants (the form of the drug in the control group and the three intervention groups are selected to be completely identical in terms of appearance and method of consumption), nurses in the dialysis unit who distribute the medication, a researcher who completes the questionnaires, a researcher who collects data related to patients such as information related to the dialysis records of patients, a researcher who conducts the tests. 3 Condition 1: chronic kidney disease. Condition 2: uremic pruritus. Intervention 1: Intervention group:Lactiplantibacillus plantarum group: Oral medication in the form of drops equivalent to CFU=1*109 of Lactiplantibacillus plantarum bacteria administered daily for 12 weeks.Probiotics are prepared by Pardis Roshd Company under the supervision of a food industry specialist. Intervention 2: Intervention group: Thermophilous Streptococcus group: Oral medication in the form of drops equivalent to CFU=1*109 of Thermophilous Streptococcus bacteria administered daily for 12 weeks. Probiotics are prepared by Pardis Roshd Company under the supervision of a food industry specialist. Intervention 3: Intervention group:Oral medication in the form of drops equivalent to CFU=28 109 evenly from Lactiplantibacillus plantarum and Thermophilous Streptococcus bacteria administered daily for 12 weeks. Probiotics are prepared by Pardis Roshd Company under the supervision of a food industry specialist. Intervention 4: Control group: Oral medication in the form of drops (placebo) with maltodextrin administered daily for 12 weeks. Prepared by Pardis Roshd Company under the supervision of a food industry specialist. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Mahboobe Rastgoo
No.243, Substreet 26.3, West Saheli, Shiraz.
Shiraz Iran (Islamic Republic of) 7143618995 +98 71 3225 3578 mahboob.rastgoo@gmail.com Shiraz University of Medical Sciences scientific Mahboobe Rastgoo
No.243, Substreet 26.3, West Saheli, Shiraz.
Shiraz Iran (Islamic Republic of) 7143618995 +98 71 3225 3578 mahboob.rastgoo@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Age over 18 years Continuous hemodialysis for more than three months They should have suffered from itching for at least 6 weeks. 18 years no limit Both Liver disease History of seizures Skin disease associated with itching Hemolytic blood disease First complaint of itching Use of any type of antibiotic Participation in another clinical trial in the past month pregnancy active cancer Active infection Sensitivity to probiotic compounds N18 L29.9 Chronic kidney disease (CKD) Pruritus, unspecified Treatment - Drugs Treatment - Devices Treatment - Drugs Placebo Intervention group:Lactiplantibacillus plantarum group: Oral medication in the form of drops equivalent to CFU=1*109 of Lactiplantibacillus plantarum bacteria administered daily for 12 weeks.Probiotics are prepared by Pardis Roshd Company under the supervision of a food industry specialist. Intervention group: Thermophilous Streptococcus group: Oral medication in the form of drops equivalent to CFU=1*109 of Thermophilous Streptococcus bacteria administered daily for 12 weeks. Probiotics are prepared by Pardis Roshd Company under the supervision of a food industry specialist. Intervention group:Oral medication in the form of drops equivalent to CFU=28 109 evenly from Lactiplantibacillus plantarum and Thermophilous Streptococcus bacteria administered daily for 12 weeks. Probiotics are prepared by Pardis Roshd Company under the supervision of a food industry specialist. Control group: Oral medication in the form of drops (placebo) with maltodextrin administered daily for 12 weeks. Prepared by Pardis Roshd Company under the supervision of a food industry specialist. Uremic pruritus( method of Scale Analogue Visual and the Persian version of the 5-Scale Itching Questionnaire). Timepoint: At the beginning of the study (before the intervention starts), during the intervention (6 weeks after the intervention starts), and after the intervention (immediately after 12 weeks from the start of the intervention). Method of measurement: To assess itching, the Scale Analogue Visual method and the Persian version of the 5-Scale Itching Questionnaire, whose validity and reliability have been confirmed by Yousef Nejad, will be used. C-REACTIVE PROTEIN. Timepoint: At the beginning of the study (before the intervention starts) and at the end of the intervention (after completing 12 weeks). Method of measurement: ELISA. Interlukine-6. Timepoint: At the beginning of the study (before the intervention starts) and at the end of the intervention (after completing 12 weeks). Method of measurement: ELISA. Shiraz University of Medical Sciences Approved 2025-03-15 Shiraz university of medical science Shiraz, Zand Street, opposite Palestine Street, Central Building of Shiraz University of Medical Sciences. Shiraz Fars Iran (Islamic Republic of)