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IRCT20191223045865N2 IRCT 2023-06-19 Bojnourd University of Medical Sciences The effect of probiotics on lupus The effect of treatment with probiotics on modulating autoimmune inflammation in patients with systemic lupus erythematosus 2023-06-20 anticipated 23 Complete https://irct.ir/trial/70735 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization: In this study, Block Randomization method with 13 blocks size 4 will be used. We will use Excel software and function (rand) to prepare random sequences. The steps of doing randomization using Excel: 1. Make a column group with A,A,B,B,C,C 2. In another column: =rand(). Assign random numbers to each letter. While doing this, use "paste values" to stop recalculating the randomization. =rand() 3. Sorting. Sort the random numbers from the lowest to the highest with selecting expand selection. 4. Sequence. Copy group column and paste it in sequence. 5. Repeat above steps 11 times And a repeat with block size 2. 6. Finish. Save the record. Concealment: A specific numerical code will be assigned to each of the randomly created sequences. Randomization will be done by the study epidemiologist and information will be only given to a study staff at the time of initiation of the intervention, Blinding description: This study is a double-blind randomized clinical trial, in other words, in this study, the researcher and the patient do not know the type of drug used (probiotic and placebo). In this study, drugs are sent in two separate boxes with codes A and B. The nature of the boxes will be reported only after taking the drug and collecting clinical and laboratory data. 3 Systemic lupus erythematosus (SLE). Intervention 1: Intervention group: In addition to common treatments for systemic lupus erythematosus, this group is given three probiotics Lactobacillus roteri, Lactobacillus rhamnosus and Bifidobacterium in a capsule daily. The duration of the intervention is 2 months. Intervention 2: Control group: In addition to common treatments for systemic lupus erythematosus, this group instead of probiotics placebo is given in a capsule daily. The duration of the intervention is 2 months. Yes - There is a plan to make this available What will be shared: All data will be shared, including the amount of medication, duration of medication use, and all outcomes. When: All data will be published after the study is done To whom: Data will be made available to all researchers upon request Conditions: Analyzed data and clinical results of treatment effect in patients are accessible Where to obtain: Clinical trial registrar How to obtain: Request from the trial registrar by email Comments:
public Bojnourd University of Medical Sciences
Central Building of North Khorasan University of Medical Sciences, Dolat Blvd, Bojnourd
Bojnourd Iran (Islamic Republic of) 74877-94149 +98 58 3151 0000 Mehdi.barati10@yahoo.com Bojnourd University of Medical Sciences scientific Medhdi Barati
Central Building of North Khorasan University of Medical Sciences, Dolat Blvd, Bojnourd
Bojnourd Iran (Islamic Republic of) 74877-94149 +98 58 3151 0000 Mehdi.barati10@yahoo.com Bojnourd University of Medical Sciences Iran (Islamic Republic of) Men and women with mild to moderate systemic lupus erythematosus based on Systemic Lupus Erythematosus Disease Activity Index score 20 years 55 years Both The patient did not receive antibacterial medication at the time of the studyPatients with lupus and no underlying disease such as kidney transplant who receive immunosuppressive drugs other than systemic lupus erythematosus for any reason. M32 Systemic lupus erythematosus (SLE) Treatment - Drugs Placebo Intervention group: In addition to common treatments for systemic lupus erythematosus, this group is given three probiotics Lactobacillus roteri, Lactobacillus rhamnosus and Bifidobacterium in a capsule daily. The duration of the intervention is 2 months. Control group: In addition to common treatments for systemic lupus erythematosus, this group instead of probiotics placebo is given in a capsule daily. The duration of the intervention is 2 months. Interleukin 10. Timepoint: In this study, blood is taken from the patient before starting the treatment, and then treatment with probiotics is started. Probiotic treatment is done for two months, and then blood is taken from the patient once again and interleukin 10 is measured. Method of measurement: ELISA. Transforming Growth Factor-β. Timepoint: In this study, blood is taken from the patient before starting the treatment, and then treatment with probiotics is started. Probiotic treatment is done for two months, and then blood is taken from the patient once again and TGF-b is measured. Method of measurement: ELISA. Systemic Lupus Erythematosus Disease Activity Index (SLEDAI). Timepoint: In this study, before the start of the treatment, blood is taken from the patient and the SLE disease activity indedx (SLAEDAI) questionnaire is completed, and then the treatment with pobiotics is started, probiotic treatment is carried out for two months, and then the SLEDAI questionnaire is completed once again. Method of measurement: Questionnaire SELDAI K2000. Bojnourd University of Medical Sciences Approved 2023-05-18 Ethical committee of North Khorasan University of Medical Sciences Dolat Blvd Bojnourd North Khorasan Iran (Islamic Republic of)