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IRCT20210117050055N1 IRCT 2021-02-21 Sabzevar University of Medical Sciences Effect of synbiotics supplement on fatigue and sleep quality in hemodialysis patients with chronic kidney disease Effect of synbiotics supplement on fatigue and sleep quality in hemodialysis patients with chronic kidney disease 2021-04-04 anticipated 60 Complete https://irct.ir/trial/53770 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: The randomization method in this study is based on quadratic blocks. Thus, fifteen blocks of four are formed and inside each block, two people are considered as intervention and two people as control. They will be in the control (receiving placebo) and intervention (receiving synbiotic supplement) groups, Blinding description: Participants and staff in the dialysis and data analysis department are unaware of the allocation of study groups. 3 chronic kidney disease. Intervention 1: Intervention group: Intervention: Recipient of Lactococare synbiotic dietary supplement capsule (500 mg) containing 12 beneficial bacterial(Lactobacillus rhamnosus, Lactobacillus holoticus, Lactobacillus casei, Bifidobacterium lactis, Lactobacillus acidophilus, Bifidobacterium brochus, Lactobacillus bulgaricus, Bifidobacterium langobacum, Lactobacillus, Lactobacillus) strains with fructooligosaccharide as prebiotic (Made by Zist Tahkmir Iran Company). Intervention 2: Control group: Control group: receiving placebo capsules containing corn starch (500 mg) with a similar appearance to synbiotic capsules (Made by Zist Tahkmir Iran Company). Yes - There is a plan to make this available What will be shared: Information on fatigue and sleep quality will be published in connection with the use of synbiotic supplements When: one year after the publication date To whom: The data will be available only to researchers working in academic and scientific institutions. Conditions: Do not use the submitted data to print articles. Where to obtain: Dr. Ali Asghar Jasmi. Email jesmiaa@gmail.com Phone:5144018300پس از How to obtain: The request will be submitted to the supervisor Dr. Ali Asghar Jasmi and his approval and registration in the Secretariat of Documents or Files. Comments:
public Mina Jangpoor
No. 31, Towhid shahr Ave, Shohada Gomnam Blvd, campus of Sabzevar University of Medical Sciences, sabzevar
Sabzevar Iran (Islamic Republic of) 9617913112 +98 51 4401 8300 mina.jangpoor@gmail.com Sabzevar University of Medical Sciences scientific Dr. Ali Asghar Jasmi
No.31, Towhid shahr Ave, Shohada Gomnam Blvd, campus of Sabzevar University of Medical Sciences, sabzevar
Sabzevar Iran (Islamic Republic of) 9617913112 +98 51 4401 8300 jesmiaa@gmail.com Sabzevar University of Medical Sciences Iran (Islamic Republic of) A patient with a diagnosis of chronic kidney disease who undergoing hemodialysis for at least 3 months. signing informed consent for participation in the study Patient with arteriovenous fistula or permanent catheter or venous arterial graft The patient undergoing hemodialysis 3 times a week for 4 hours each time Patient with KT / V> 1 Do not suffer from hearing and vision disorders No neurological disorders and a history of hospitalization in the psychiatric ward age range of 18 to 65 years 18 years 65 years Both Active infection during the last 30 days Pregnant or lactating mothers Taking antibiotics, prebiotics, probiotics, synbiotics, vitamin supplements or antioxidants during the last 30 days Suffering from autoimmune diseases or connective tissue disorders History of cardiovascular diseases Diabetic foot infection Gastrointestinal diseases (inflammatory bowel disease, ulcerative colitis, Crohn's disease, celiac disease, lactose intolerance or allergy, irritable bowel syndrome) Liver disease (such as hepatitis B, hepatitis C) suffering from various types of malignancies Smoking more than 10 cigarettes per day Participate in other drug interventions hemoglobin less than 8 mg/dl PSQI score less than 6 (good sleep quality) acquisition of CFS score less than 18 N18.4 Chronic kidney disease, stage 4 (severe) Treatment - Other Placebo Intervention group: Intervention: Recipient of Lactococare synbiotic dietary supplement capsule (500 mg) containing 12 beneficial bacterial(Lactobacillus rhamnosus, Lactobacillus holoticus, Lactobacillus casei, Bifidobacterium lactis, Lactobacillus acidophilus, Bifidobacterium brochus, Lactobacillus bulgaricus, Bifidobacterium langobacum, Lactobacillus, Lactobacillus) strains with fructooligosaccharide as prebiotic (Made by Zist Tahkmir Iran Company) Control group: Control group: receiving placebo capsules containing corn starch (500 mg) with a similar appearance to synbiotic capsules (Made by Zist Tahkmir Iran Company) Fatigue. Timepoint: 2 months. Method of measurement: Chalders Fatigue Scale. Sleep quality. Timepoint: 2 months. Method of measurement: Pittsburgh Sleep Quality Scale. Sabzevar University of Medical Sciences Approved 2021-01-13 Ethics Committee of Sabzevar University of Medical Sciences No. 31, Towhid shahr Ave, Shohada Gomnam Blvd, campus of Sabzevar University of Medical Sciences, sabzevar sabzevar Razavi Khorasan Iran (Islamic Republic of)