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IRCT20180712040438N2 IRCT 2020-01-10 Tabriz University of Medical Sciences Effect of probiotic supplement in treatment of psoriasis Comparison of the efficacy of probiotic supplement in inflammatory markers, metabolic parameters and some clinical parameters in patients with psoriasis 2019-08-11 anticipated 44 Complete https://irct.ir/trial/41186 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: From among the patients who volunteer to participate in the study, 44 individuals will be selected by simple randomization. Then by using the Random Allocation Software, the subjects will be allocated into either probiotic or placebo group, stratified by sex and age. The sequence of randomization will be kept in a safe place by an independent party and is not aware of the study, Blinding description: In this double-blind study, no patient and investigator will be aware of the treatment assignments for the duration of the study. For blinding the trial, the Probiotic Capsule and placebo, will be identical in appearance, packaging, and labeling. All capsules will be packed and encoded by the company (Takgene Zist Company). 3 Psoriasis. Intervention 1: Intervention group: Patients in this group will receive probiotic supplements for 8 weeks. Probiotic supplement is a capsule containing multi-strain probiotic with at least 1.8× 10 9 colony forming units (CFU) (a product by TakZist Gene Co.and made in The Iran) and used once a day with lunch. Intervention 2: control group: participants will be instructed to take two capsules daily, each contains of starch as placebo for 8 weeks. Placebo capsules are completely similar to probiotic capsules so that they are hardly distinguished from each other (they are made by TAKGENE ZIST pharmaceutical company). We will contact the patients weekly to ensure that participants would act in compliance with the protocol of study, and remind them to take their capsules daily. Yes - There is a plan to make this available What will be shared: Data collected for the primary outcomes will be shared When: Accessibility to data is possible 8 months after publication. To whom: The data will only be available for people working in academic institutions. Conditions: The data of the present study will only be accessible by other researchers, for conducting Meta analysis Where to obtain: Jalal Moludi, Faculty of Nutrition and Food Sciences, Tabriz University of Medical Sciences, +989399516760, jmoludi@yahoo.com How to obtain: Any one who request our data should provide a brief explanation of the purpose and method of their meta-analysis study. The applicant's request will be reviewed by the researchers and if all agree, the requested data will be sent to the applicant via email in the form of an Excel file. All these steps will not take more than 10 days. Comments:
public Jalal Moludi
Tabriz University of Medical Science, Nutrition Faculty, Attar Neyshabori, Goldasht street, Tabriz, Iran
Tabriz Iran (Islamic Republic of) 5166614711 +98 41 3335 2148 Moludij@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Jalal Moludi
Faculty of Nutrition , Attar Neishabouri Avenue, Golgasht street,Tabriz, Postal Code: 5166614711
Tabriz Iran (Islamic Republic of) 5166614711 +98 41 3335 2148 moludij@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) diagnosed with psoriasis Subjects aged 15-50 years 18 years 50 years Both patient with chronic renal failure; hemodialysis receiving immunosuppressive, anti-inflammatory and corticosteroid drugs history of supplementation with pre/pro/symbiotic or antioxidants during previous two months L40.0 Psoriasis vulgaris Treatment - Drugs Placebo Intervention group: Patients in this group will receive probiotic supplements for 8 weeks. Probiotic supplement is a capsule containing multi-strain probiotic with at least 1.8× 10 9 colony forming units (CFU) (a product by TakZist Gene Co.and made in The Iran) and used once a day with lunch. control group: participants will be instructed to take two capsules daily, each contains of starch as placebo for 8 weeks. Placebo capsules are completely similar to probiotic capsules so that they are hardly distinguished from each other (they are made by TAKGENE ZIST pharmaceutical company). We will contact the patients weekly to ensure that participants would act in compliance with the protocol of study, and remind them to take their capsules daily. Interleukin 6 Level. Timepoint: Baseline and 2 months after intervention. Method of measurement: via ELISA kit. Interleukin 10 Level. Timepoint: Baseline and 2 months after intervention. Method of measurement: via ELISA kit. Total cholesterol. Timepoint: Baseline and 2 months after intervention. Method of measurement: spectrophotometry. Triglycerides. Timepoint: Baseline and 2 months after intervention. Method of measurement: spectrophotometry. High density lipoprotein. Timepoint: Baseline and 2 months after intervention. Method of measurement: spectrophotometry. Low density lipoprotein. Timepoint: Baseline and 2 months after intervention. Method of measurement: Formula. Fasting Blood Sugar. Timepoint: Baseline and 2 months after intervention. Method of measurement: Enzymatic. Weight. Timepoint: Baseline and 2 months after intervention. Method of measurement: scale. Body Mass Index. Timepoint: Baseline and 2 months after intervention. Method of measurement: formula. Hip Circumfrance. Timepoint: Baseline and 2 months after intervention. Method of measurement: meter. Waist Circumfrance. Timepoint: Baseline and 2 months after intervention. Method of measurement: meter. Dermatology Life Quality Index (DLQI) score. Timepoint: Baseline and 2 months after intervention. Method of measurement: Dermatology Life Quality Index questionnaire. Psoriasis Area Severity Index (PASI) score. Timepoint: Baseline and 2 months after intervention. Method of measurement: Psoriasis Area and Severity Index questionnaire. Tabriz University of Medical Sciences Approved 2019-07-31 Ethics Committee of Tabriz University of Medical Sciences Tabriz University of Medical Sciences, Attar Neyshabouri Av., Golgasht St Tabriz East Azarbaijan Iran (Islamic Republic of)