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Evaluation of the effect of oral probiotics on population, receptor expression, and related cytokines of T and B cells subsets in psoriasis patients

Protocol summary

Study aim
Evaluation of the effect of oral probiotics on population, receptor expression, and related cytokines of T and B cells subsets in psoriasis patients
Design
Randomized, double-blind, phase 2, placebo-controlled clinical trial in 40 patients
Settings and conduct
Patients with moderate to severe psoriasis are selected by physician by referring them to a specialized rheumatology clinic, and a blood sample is taken from the patients after taking a three-month period of probiotic tablets to check the severity of the disease. Moreover, the population and expression levels of TH1, TH2, B cells, TH17, and Treg cells in the patient's blood samples are evaluated by flow cytometry. In this study, Blinding will be performed for patients, physician, and experimenter.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age of 18 to 65 years old; signing the informed consent form; patients with the diagnosis of moderate to severe psoriasis based on Psoriasis Area and Severity Index( PASI score). Exclusion criteria: pregnancy or lactation; suffering from other autoimmune diseases 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.
Intervention groups
Intervention Group: Psoriasis patients consume one probiotic LactoCare tablet (Zist Takhmir company) orally for three months and then blood samples are examined. Control Group: Patients consume a LactoCare placebo tablet daily(the packaging and color are similar to the LactoCare tablet ) for three months and then their blood samples will be examined.
Main outcome variables
The population and expression levels receptors of TH1, TH2, B cells, TH17, and Treg by flowcytometry

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20221213056802N1
Registration date: 2023-03-01, 1401/12/10
Registration timing: prospective

Last update: 2023-03-01, 1401/12/10
Update count: 0
Registration date
2023-03-01, 1401/12/10
Registrant information
Name
Seyed-Alireza Esmaili
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3800 2379
Email address
esmaeiliar@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-19, 1402/01/30
Expected recruitment end date
2024-02-20, 1402/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of oral probiotics on population, receptor expression, and related cytokines of T and B cells subsets in psoriasis patients
Public title
The effect of oral probiotic(LactoCare) on psoriasis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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)
Exclusion criteria:
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
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Used
Assignment
Parallel
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.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mashhad University Of Medical Science
Street address
Immunology department, School of Medicine, Kalantary street, Mashhad University of Medical Science
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Approval date
2022-03-02, 1400/12/11
Ethics committee reference number
Ir.mums.medical.rec.1401.321

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
The population of TH1
Timepoint
3 months later the consumption of oral probiotics
Method of measurement
Flowcytometry

2

Description
The population of TH2
Timepoint
3 months later the consumption of oral probiotics
Method of measurement
Flowcytometry

3

Description
The population of Treg
Timepoint
3 months later the consumption of oral probiotics
Method of measurement
Flowcytometry

4

Description
The population of B cells
Timepoint
3 months later the consumption of oral probiotics
Method of measurement
Flowcytometry

5

Description
The population of TH17
Timepoint
3 months later the consumption of oral probiotics
Method of measurement
Flowcytometry

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: patients are instructed to consume orally one LactoCare probiotic tablet(zist takhmir, Iran) daily for 3 months
Category
Treatment - Drugs

2

Description
Control group: patients are instructed to consume orally one LactoCare probiotic placebo tablet(zist takhmir, Iran) daily for 3 months
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Bozorgmehr medical building
Full name of responsible person
Zahrz Rezaie Yazdi
Street address
Bozorgmehr medical building, second Mohtashami, Aref street 1, Ahmad Abad avenue
City
Mashhad
Province
Razavi Khorasan
Postal code
9176664692
Phone
+98 51 3844 4876
Email
Rezaieyazdiz@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Zahra Meshkat
Street address
Research council, school of medicine, Kalantary street, Mashhad University Of Medical Science
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2109
Email
MeshkatZ@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Hanieh Kolahdooz Ghuchani
Position
Research assistance
Latest degree
Master
Other areas of specialty/work
Immunology
Street address
Immunology department, school of medicine, Kalantary street, Mashhad University Of Medical Science
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
009838691760
Email
Haniz93@rocketmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Seyed-Alireza Esmaili
Position
Assistance professor
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
Immunology department, school of medicine, Kalantary street, Mashhad University Of Medical Science
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2379
Email
esmaeiliar@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hanieh Kolahdooz Ghochani
Position
Research assistance
Latest degree
Master
Other areas of specialty/work
Immunology
Street address
Immunology department, school of medicine, Kalantary street, Mashhad University Of Medical Science
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3869 1760
Email
haniz93@rocketmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information
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
No - There is not 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
No - There is not a plan to make this available
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