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IRCT20191124045483N1 IRCT 2020-03-20 Tabriz University of Medical Sciences The Effect of Probiotic Supplementation on the Inflammatory and Oxidative Markers and Some Clinical Parameters in Patients with Psoriasis The Effect of Probiotic Supplementation Containing Lactobacillus & Bifidobacterium Species on the Inflammatory and Oxidative Markers and Some Clinical Parameters in Patients with Psoriasis 2020-03-28 anticipated 44 Complete https://irct.ir/trial/43738 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Single, Purpose: Supportive, Randomization description: Selected individuals will be randomly allocated to 2 intervention groups (probiotic)and control group (placebo after obtaining written consent by using random blocking method (4 and 8 blocks) and RAS software (Random Allocation Software) and allocation ratio of 1: 1, Blinding description: Participants have been blinded by supplementation of probiotic and placebo in packaging, shape, color and smell alike. Investigators have also been blinded in terms of prescribing two types of intervention (probiotic or placebo with number of intervention 1 or 2) through numbers obtained by random allocation software. N/A Participants are patients with psoriasis. Psoriasis is a skin condition that appears in the form of thick white-silver skins and itchy plaques on the surface of the skin.. Intervention 1: Intervention group: Will intake 2 capsules orally in a day that containing probiotic supplements at least 1.6× 109 cfu/g of probiotics including (Lactobacillus acidophilus, Bifidobacterium bifidum, Bifidobacterium lactis and Bifidobacterium langum) for 8 weeks, which were prepared by ZIST TAKGENE Co. Intervention 2: Control group: Will intake 2 placebo capsules daily for 8 weeks. Placebo capsules containing starch that are similar in taste, color and odor to probiotic capsules and were prepared by ZIST TAKGENE Co. Yes - There is a plan to make this available What will be shared: Requested data will be provided to researchers for statistical analysis of the submitted proposal (meta-analysis). When: Starting immediately after publication To whom: Data will be available to researchers as well as journals. Conditions: The data will be available to researchers upon request and submission of a proposal to perform meta-analysis using IPD data after being unidentified. Also, in exceptional cases, data will be made available to journals for checking. Where to obtain: Refer to the email address (farshbafa@tbzmed.ac.ir) How to obtain: The requests will be sent by email and data will be available within a week. Comments:
public Azizeh Farshbaf-khalili
Nutrition Research Center, Tabriz University of Medical Sciences, Attar Neyshabouri Avenue, Golgasht
Tabriz Iran (Islamic Republic of) 5166614711 +98 41 3335 2295 farshbafa@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Azizeh Farshbaf-khalili
Nutrition Research Center, Tabriz University of Medical Sciences, Attar Neyshabouri Avenue, Golgasht
Tabriz Iran (Islamic Republic of) 5166614711 +98 41 3335 2295 farshbafa@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Patients with the diagnosis of the medium to severe psoriasis are based on the classification criteria for Psoriasis vulgaris. Patients aged between 18 and 50 (until the date of screening) The inclusion of participants in the study is informed by the understanding of all the procedures of the study, voluntary contributions and signed consent form. 18 years 50 years Both Pregnant women, prior to pregnancy or lactation The existence and history of conditions or serious wounds in the heart, lungs, kidney and other vital organs and the endocrine system. Also patients with respiratory and cancer disorders, tuberculosis and HIV infections. patients with chronic diarrhea or peptic ulcer up to one year patients suffering from malignancy or tumor patients with acute and chronic infectious diseases Patients with psychiatric disorders, alcohol and drug abuse Patients who refuse to participate in the study Treatment - Other Placebo Intervention group: Will intake 2 capsules orally in a day that containing probiotic supplements at least 1.6× 109 cfu/g of probiotics including (Lactobacillus acidophilus, Bifidobacterium bifidum, Bifidobacterium lactis and Bifidobacterium langum) for 8 weeks, which were prepared by ZIST TAKGENE Co. Control group: Will intake 2 placebo capsules daily for 8 weeks. Placebo capsules containing starch that are similar in taste, color and odor to probiotic capsules and were prepared by ZIST TAKGENE Co. Metabolic parameters [serum glucose and insulin levels, HOMA-IR and lipid profile (Triglyceride، Total cholesterol، LDL- cholesterol و HDL- cholesterol)] in both study groups. Timepoint: Metabolic parameters measurement [serum glucose and insulin levels, HOMA-IR and lipid profile (Triglyceride، Total cholesterol، LDL- cholesterol و HDL- cholesterol)] at baseline and 8 weeks (end of study) in both study groups. Method of measurement: Calorimetric methods (ELISA, spectrophotometry, autoanalyzer). Systolic and diastolic blood pressure and anthropometric indices (weight, Body Mass Index, waist circumference, hip circumference and Waist to Hip Ratio) in both study groups. Timepoint: Measurement of systolic and diastolic blood pressure and anthropometric indices (weight, Body Mass Index, waist circumference, hip circumference and Waist to Hip Ratio) at baseline and 8 weeks (end of study) in both study groups. Method of measurement: A mercury barometer will be used to measure systolic and diastolic blood pressure, and digital scales, gauges and tape meters will be used for anthropometric measurements. Levels of inflammatory biomarkers (Lipopolysaccharide and high sensitivity -CRP) in both study groups. Timepoint: Measurement of levels of inflammatory markers (Lipopolysaccharide and high sensitivity -CRP) at baseline and 8 weeks later (end of study) in both study groups. Method of measurement: Calorimetric methods (ELISA, spectrophotometry, autoanalyzer). Levels of oxidative indices (Total Antioxidant Capacity and Malondialdehyde) in both study groups. Timepoint: Measurement of oxidative index levels (Total Antioxidant Capacity and Malondialdehyde) at baseline and 8 weeks (end of study) in both study groups. Method of measurement: Calorimetric methods (ELISA, spectrophotometry, autoanalyzer). Clinical parameters (Health related quality of life questionnaire or SF-36, PASI or Psoriasis area and severity index and BDI-II or Beck Depression Inventory 2) in both study groups. Timepoint: Assessment of Clinical parameters (Health related quality of life questionnaire or SF-36, PASI or Psoriasis area and severity index and BDI-II or Beck Depression Inventory 2) at baseline and 8 weeks (end of study) in both study groups. Method of measurement: Questionnaires SF-36, PASI and BDI-II. Tabriz University of Medical Sciences Approved 2019-11-25 Ethics Committee of Tabriz University of Medical Sciences Research Vice-chancellor of Tabriz University of Medical Sciences., End of Golgasht Ave., Tabriz., Iran Tabriz East Azarbaijan Iran (Islamic Republic of)