Comparison of the efficacy of probiotic supplement in inflammatory markers, metabolic parameters and some clinical parameters in patients with psoriasis
The aim of the present study was to evaluate the effect of probiotic supplementation on the level of inflammatory factors in psoriasis patients.
Design
Randomized double-blind clinical trial with two arm parallel groups
Settings and conduct
The trial will be conducted at the Sheikh al-Rays Clinic affiliated to Tabriz University of Medical Sciences. All patients will be screened for eligibility by a dermatologist. Individuals who are willing to participate in the study will be evaluated to meet the inclusion criteria. They are then asked to complete an informed consent form. A third party blind to the study will deliver sequences extracted from the random allocation software. After nocturnal fasting, blood samples will be collected and supplements delivered to participants. The duration of the supplementary period will be 8 weeks.
Participants/Inclusion and exclusion criteria
Forty four patients with psoriasis will be included in the study. Subjects with chronic renal failure and history of supplementation with probiotics will not be included.
Intervention groups
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. To ensure supplement consumption, patients will be contacted weekly.
Control group: participants will be instructed to take one capsules daily, each contains of maltodextrin 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).
Main outcome variables
Serum Levels of Inflammatory Factors (Interleukin 6 and 10)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180712040438N2
Registration date:2020-01-10, 1398/10/20
Registration timing:retrospective
Last update:2020-01-10, 1398/10/20
Update count:0
Registration date
2020-01-10, 1398/10/20
Registrant information
Name
Jalal Moludi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3335 2148
Email address
jmoludi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-11, 1398/05/20
Expected recruitment end date
2019-11-22, 1398/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of probiotic supplement in inflammatory markers, metabolic parameters and some clinical parameters in patients with psoriasis
Public title
Effect of probiotic supplement in treatment of psoriasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
diagnosed with psoriasis
Subjects aged 15-50 years
Exclusion criteria:
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
Age
From 18 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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)
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Attar Neyshabouri Av., Golgasht St
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Approval date
2019-07-31, 1398/05/09
Ethics committee reference number
IR.TBZMED.REC.1398.504
Health conditions studied
1
Description of health condition studied
Psoriasis
ICD-10 code
L40.0
ICD-10 code description
Psoriasis vulgaris
Primary outcomes
1
Description
Interleukin 6 Level
Timepoint
Baseline and 2 months after intervention
Method of measurement
via ELISA kit
2
Description
Interleukin 10 Level
Timepoint
Baseline and 2 months after intervention
Method of measurement
via ELISA kit
3
Description
total cholesterol
Timepoint
Baseline and 2 months after intervention
Method of measurement
spectrophotometry
4
Description
triglycerides
Timepoint
Baseline and 2 months after intervention
Method of measurement
spectrophotometry
5
Description
high density lipoprotein
Timepoint
Baseline and 2 months after intervention
Method of measurement
spectrophotometry
6
Description
low density lipoprotein
Timepoint
Baseline and 2 months after intervention
Method of measurement
Formula
7
Description
Fasting Blood Sugar
Timepoint
Baseline and 2 months after intervention
Method of measurement
Enzymatic
8
Description
Weight
Timepoint
Baseline and 2 months after intervention
Method of measurement
scale
9
Description
Body Mass Index
Timepoint
Baseline and 2 months after intervention
Method of measurement
formula
10
Description
Hip Circumfrance
Timepoint
Baseline and 2 months after intervention
Method of measurement
meter
11
Description
Waist Circumfrance
Timepoint
Baseline and 2 months after intervention
Method of measurement
meter
12
Description
Dermatology Life Quality Index (DLQI) score
Timepoint
Baseline and 2 months after intervention
Method of measurement
Dermatology Life Quality Index questionnaire
13
Description
Psoriasis Area Severity Index (PASI) score
Timepoint
Baseline and 2 months after intervention
Method of measurement
Psoriasis Area and Severity Index questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
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.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Sheikh Al-Rais Clinic
Full name of responsible person
Dr. Armaghan Ghareaghaji Zare
Street address
Sheikh Al Rais Building - Azadi Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 2148
Fax
Email
Armaghan.g.zare@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Abolghasem Jouyban
Street address
Vice Chancellor for Research No 2 Central Building, Tabriz University of Medical Sciences, Daneshgah Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7581
Fax
+98 41 3334 0634
Email
Ajouyban@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Jalal Moludi
Position
PhD Candidate
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
Tabriz University of Medical Science, Nutrition Faculty, Attar Neyshabori, Goldasht street, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 2148
Fax
+98 41 3335 2148
Email
Moludij@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Jalal Moludi
Position
PhD Candidate
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Faculty of Nutrition , Attar Neishabouri Avenue, Golgasht street,Tabriz, Postal Code: 5166614711
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 2148
Fax
+98 41 3335 2148
Email
moludij@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Jalal Moludi
Position
PhD Candidate
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Faculty of Nutrition , Attar Neishabouri Avenue, Golgasht street,Tabriz, Postal Code: 5166614711
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 2148
Email
jmoludi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Data collected for the primary outcomes will be shared
When the data will become available and for how long
Accessibility to data is possible 8 months after publication.
To whom data/document is available
The data will only be available for people working in academic institutions.
Under which criteria data/document could be used
The data of the present study will only be accessible by other researchers, for conducting Meta analysis
From where data/document is obtainable
Jalal Moludi, Faculty of Nutrition and Food Sciences, Tabriz University of Medical Sciences, +989399516760, jmoludi@yahoo.com
What processes are involved for a request to access data/document
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.