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IRCT20201019049073N1 IRCT 2021-01-08 Mashhad University of Medical Sciences Evaluate of effect probiotic on treatment of systemic lupus erythematosus SLE(systemic lupus erythematosus) Evaluate the effect of probiotics on the improvement of autoimmune inflammation in patients with systemic lupus erythematosus 2020-10-28 anticipated 46 Complete https://irct.ir/trial/51718 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Basic scienece, Other design features: Our review of past studies showed that no similar studies have been conducted in this area.Therefore, this study can provide new results on the effect of probiotics on systemic lupus erythematosus disease, Randomization description: Method of block randomization Unit of randomization individual Tools used in randomization computer software The type of randomization in this study is simple random sampling. To select the participants in this study, 50 patients from whom the diagnosis of lupus has been confirmed are randomly included in the study. Then 25 patients are randomly divided into probiotic group and 25 patients into placebo group, Blinding description: Participants will receive the same drug or placebo. The main researcher is unaware of the effect of the drug on improving quality of life and effective immune responses. 3 SLE( Systemic lupus erythematosus ). Intervention 1: Intervention group: In addition to common therapies, one oral probiotic FamiLact 2plus daily includes the strains of Lactobacillus acidophilus, Lactobacillus casei, Lactobacillus rhamnosus, Lactobacillus salivarius, Lactobacillus reuteri, Bifidobacterium lactis, Bifidobacterium longum, Bifidobacterium bifidum. The duration of the intervention is 4 months. FamiLact 2Plus is from Zist Takhmir Company, made in Iran. Intervention 2: Control group: In addition to common treatments, one placebo is given daily.The duration of the intervention is 4 months. The placebo is from Zist Takhmir Company, made in Iran. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information.
public Arezoo Faridzadeh
Department of Immunology، faculty of medical, Mashhad Ferdowsi University, Ferdowsi square, Mashhad city
Mashhad Iran (Islamic Republic of) 9177948564 +98 51 3800 2000 Faridzadeha961@mums.ac.ir Mashhad University of Medical Sciences scientific Arezoo Faridzadeh
Department of Immunology، faculty of medical, Mashhad Ferdowsi University, Ferdowsi square, Mashhad city
mashhad Iran (Islamic Republic of) 9177948564 +98 51 3800 2000 Faridzadeha961@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) All patients with SLE have a SLEDAI score of 4.5 to 10. Patients should be between 18 and 45 years old. Patients are willing to cooperate in the project. 18 years 45 years Both Patients will be excluded from the study if there is a change in the dose or number of medications taken by patients. kinds of autoimmune diseases Treatment - Drugs Placebo Intervention group: In addition to common therapies, one oral probiotic FamiLact 2plus daily includes the strains of Lactobacillus acidophilus, Lactobacillus casei, Lactobacillus rhamnosus, Lactobacillus salivarius, Lactobacillus reuteri, Bifidobacterium lactis, Bifidobacterium longum, Bifidobacterium bifidum. The duration of the intervention is 4 months. FamiLact 2Plus is from Zist Takhmir Company, made in Iran. Control group: In addition to common treatments, one placebo is given daily.The duration of the intervention is 4 months. The placebo is from Zist Takhmir Company, made in Iran. IL17, Evaluation of FOXP3, T-bet, GATA-3 and ROR γt transcription factor gene expression by SYBR Green real-time RT-PCR method. Timepoint: Before intervention, 4 months after intervention. Method of measurement: Elisa test, SYBR Green real-time RT-PCR. Mashhad University of Medical Sciences Approved 2020-12-28 Ethics committee of Mshhad University of medical Sciences Ferdowsi University of Medical Sciences , Azadi Sq, Mashhad-Iran mashhad Razavi Khorasan Iran (Islamic Republic of)