Protocol summary
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Study aim
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Determination of effect of 60 days intervention with Lactobacillus and Bifidobacterium probiotic supplements on inflammatory and oxidative indices and some clinical indicators in patients with psoriasis compared to control group
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Design
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A double-blind randomized controlled clinical trial
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Settings and conduct
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This study will be performed in 44 patients with psoriasis for 60 days. Eligible patients from among patients referring to three different socio-economic health centers in Tabriz University of Medical Sciences will enter the study based on entry and failure criteria after obtaining informed written consent. Subjects are then assigned to two groups (intervention & placebo).The general health questionnaire, validated appetite assessment questionnaire, physical activity questionnaire, anthropometric measurements (waist circumference, hip circumference, height and weight for BMI calculation), and blood pressure measurements for each person will be completed. In order to measure the serum levels of metabolic parameters (TC, TG, HDL-C, LDL-C, FBS & insulin) as well as serum levels of inflammatory indices (hs-CRP and LPS) and oxidative indices (MDA & TAC) at baseline and at the end of the study in subjects with fasting (after 12-10 hours of fasting) blood sampling (5 ml) will be done. Incidentally, dietary intake of the subjects will be evaluated by a 3-day food record questionnaire.
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Participants/Inclusion and exclusion criteria
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Participants: Women & Men 18 to 50 years old with psoriasis
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Intervention groups
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Intervention Group: 2 capsules containing probiotic supplement (Lactobacillus acidophilus, Bifidobacterium bifidum, Bifidobacterium lactis and Bifidobacterium langum) daily. Control Group: 2 placebo capsules containing starch per day.
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Main outcome variables
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1)Inflammatory Markers' Levels (hs-CRP & LPS), 2)Oxidative Markers' Levels (MDA & TAC), 3)Scores of SF-36, PASI & BDI-II Questionnaires
General information
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Reason for update
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Due to the start of sampling on 28 March 2020, the expected start and end date of sampling was updated.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20191124045483N1
Registration date:
2020-03-20, 1399/01/01
Registration timing:
prospective
Last update:
2020-04-21, 1399/02/02
Update count:
1
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Registration date
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2020-03-20, 1399/01/01
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-03-28, 1399/01/09
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Expected recruitment end date
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2020-05-20, 1399/02/31
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The Effect of Probiotic Supplementation Containing Lactobacillus & Bifidobacterium Species on the Inflammatory and Oxidative Markers and Some Clinical Parameters in Patients with Psoriasis
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Public title
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The Effect of Probiotic Supplementation on the Inflammatory and Oxidative Markers and Some Clinical Parameters in Patients with Psoriasis
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
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.
Exclusion criteria:
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
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Age
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From 18 years old to 50 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
44
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Single
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-11-25, 1398/09/04
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Ethics committee reference number
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IR.TBZMED.REC.1398.916
Health conditions studied
1
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Description of health condition studied
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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.
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Metabolic parameters [serum glucose and insulin levels, HOMA-IR and lipid profile (Triglyceride، Total cholesterol، LDL- cholesterol و HDL- cholesterol)] in both study groups.
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Timepoint
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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.
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Method of measurement
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Calorimetric methods (ELISA, spectrophotometry, autoanalyzer)
2
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Description
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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.
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Timepoint
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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.
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Method of measurement
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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.
3
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Description
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Levels of inflammatory biomarkers (Lipopolysaccharide and high sensitivity -CRP) in both study groups.
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Timepoint
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Measurement of levels of inflammatory markers (Lipopolysaccharide and high sensitivity -CRP) at baseline and 8 weeks later (end of study) in both study groups.
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Method of measurement
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Calorimetric methods (ELISA, spectrophotometry, autoanalyzer)
4
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Description
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Levels of oxidative indices (Total Antioxidant Capacity and Malondialdehyde) in both study groups.
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Timepoint
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Measurement of oxidative index levels (Total Antioxidant Capacity and Malondialdehyde) at baseline and 8 weeks (end of study) in both study groups.
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Method of measurement
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Calorimetric methods (ELISA, spectrophotometry, autoanalyzer)
5
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Description
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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.
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Timepoint
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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.
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Method of measurement
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Questionnaires SF-36, PASI and BDI-II
Intervention groups
1
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Description
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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.
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Category
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Treatment - Other
2
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Description
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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.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tabriz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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Requested data will be provided to researchers for statistical analysis of the submitted proposal (meta-analysis).
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When the data will become available and for how long
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Starting immediately after publication
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To whom data/document is available
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Data will be available to researchers as well as journals.
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Under which criteria data/document could be used
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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.
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From where data/document is obtainable
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Refer to the email address (farshbafa@tbzmed.ac.ir)
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What processes are involved for a request to access data/document
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The requests will be sent by email and data will be available within a week.
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Comments
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