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IRCT20221213056802N1 IRCT 2023-03-01 Mashhad University of Medical Sciences The effect of oral probiotic(LactoCare) on psoriasis patients Evaluation of the effect of oral probiotics on population, receptor expression, and related cytokines of T and B cells subsets in psoriasis patients 2023-04-19 anticipated 40 Complete https://irct.ir/trial/67384 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Following three months of taking the probiotic tablets, 10 cc of whole blood will be collected from both groups of patients (treatment and placebo) and the population of lymphocyte cells will be checked, Randomization description: By using random number generation software, a set of numbers from 1 to 40 will be generated randomly. These numbers are given to the patients in the form of a sealed envelope, and then the patients with odd numbers receive the odd-labeled intervention, and the patients with even numbers receive the even-labeled intervention, Blinding description: Participants have been blinded by supplementation of probiotic and placebo in similar packaging, shape, and color. Investigator and physician have also been blinded in terms of prescribing two types of intervention (probiotic and placebo were considered as odd and even-labeled interventions) through numbers obtained by random allocation software that would be done by one colleague. 2-3 Psoriasis. Intervention 1: Intervention group: patients are instructed to consume orally one LactoCare probiotic tablet(zist takhmir, Iran) daily for 3 months. Intervention 2: Control group: patients are instructed to consume orally one LactoCare probiotic placebo tablet(zist takhmir, Iran) daily for 3 months. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information
public Hanieh Kolahdooz Ghuchani
Immunology department, school of medicine, Kalantary street, Mashhad University Of Medical Science
Mashhad Iran (Islamic Republic of) 9177948564 009838691760 Haniz93@rocketmail.com Mashhad University of Medical Sciences scientific Seyed-Alireza Esmaili
Immunology department, school of medicine, Kalantary street, Mashhad University Of Medical Science
Mashhad Iran (Islamic Republic of) 9177948564 +98 51 3800 2379 esmaeiliar@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Age of 18 to 65 years Signing the informed consent form Patients with the diagnosis of the moderate to severe psoriasis based on Psoriasis Area and Severity Index( PASI score) 18 years 65 years Both Pregnant or lactation Suffering from other autoimmune disease and inflammation disease Suffering from cirrhosis and hepatic disease Suffering from metabolic syndrome Suffering from severe renal disease The consumption of antibiotics and any kind of probiotics 2 weeks ago Worsening of signs and symptoms of psoriasis during treatment L40.0 Psoriasis vulgaris Treatment - Drugs Placebo Intervention group: patients are instructed to consume orally one LactoCare probiotic tablet(zist takhmir, Iran) daily for 3 months Control group: patients are instructed to consume orally one LactoCare probiotic placebo tablet(zist takhmir, Iran) daily for 3 months The population of TH1. Timepoint: 3 months later the consumption of oral probiotics. Method of measurement: Flowcytometry. The population of TH2. Timepoint: 3 months later the consumption of oral probiotics. Method of measurement: Flowcytometry. The population of Treg. Timepoint: 3 months later the consumption of oral probiotics. Method of measurement: Flowcytometry. The population of B cells. Timepoint: 3 months later the consumption of oral probiotics. Method of measurement: Flowcytometry. The population of TH17. Timepoint: 3 months later the consumption of oral probiotics. Method of measurement: Flowcytometry. Mashhad University of Medical Sciences Approved 2022-03-02 Ethics committee of Mashhad University Of Medical Science Immunology department, School of Medicine, Kalantary street, Mashhad University of Medical Science Mashhad Razavi Khorasan Iran (Islamic Republic of)