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Evaluate the effect of probiotics on the improvement of autoimmune inflammation in patients with systemic lupus erythematosus

Protocol summary

Study aim
Evaluation of probiotic administration on immune responses and clinical manifestations in patients with systemic lupus erythematosus
Design
Clinical trial with control group, community-based, with parallel groups, thriple blind, randomized
Settings and conduct
Before and 4 months after the intervention, 5 cc of blood is taken from the brachial vein of patients for examinations, real time PCR and preparation of serum for ELISA test.In monthly visits, in addition to the activity of the disease, a checklist of the number and dose of drugs used by patients in both groups is recorded to be compared at the end of the study and the confusing points of treatment changes are removed from the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All patients with systemic lupus erythematosus between the ages of 18 to 45 years living in Mashhad and surrounding cities with a SLEDAI score between 4.5 to 10.Be willing to cooperate in the project. Exclusion criteria: Patients who are not satisfied to continue cooperation.
Intervention groups
Patients are divided into two equal groups (23 people in each group) using block block randomization method and in one group, in addition to common treatments for lupus, oral probiotic Lact 2 Plus is prescribed, and in the other group, in addition to common treatments, A placebo is prescribed.
Main outcome variables
Evaluation of IL17 protein levels, Evaluation of FOXP3, T-bet, GATA-3 and ROR γt transcription factor gene expression by SYBR Green real-time RT-PCR at the beginning of the process, four months after the course

General information

Reason for update
Acronym
SLE(systemic lupus erythematosus)
IRCT registration information
IRCT registration number: IRCT20201019049073N1
Registration date: 2021-01-08, 1399/10/19
Registration timing: registered_while_recruiting

Last update: 2021-01-08, 1399/10/19
Update count: 0
Registration date
2021-01-08, 1399/10/19
Registrant information
Name
Arezoo Faridzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3802 2229
Email address
faridzadeha961@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-28, 1399/08/07
Expected recruitment end date
2022-12-10, 1401/09/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluate the effect of probiotics on the improvement of autoimmune inflammation in patients with systemic lupus erythematosus
Public title
Evaluate of effect probiotic on treatment of systemic lupus erythematosus
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with SLE have a SLEDAI score of 4.5 to 10. Patients should be between 18 and 45 years old. Patients are willing to cooperate in the project.
Exclusion criteria:
Patients will be excluded from the study if there is a change in the dose or number of medications taken by patients.
Age
From 18 years old to 45 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
Sample size
Target sample size: 46
Randomization (investigator's opinion)
Randomized
Randomization description
Method of block randomization Unit of randomization individual Tools used in randomization computer software The type of randomization in this study is simple random sampling. To select the participants in this study, 50 patients from whom the diagnosis of lupus has been confirmed are randomly included in the study. Then 25 patients are randomly divided into probiotic group and 25 patients into placebo group.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Participants will receive the same drug or placebo. The main researcher is unaware of the effect of the drug on improving quality of life and effective immune responses.
Placebo
Used
Assignment
Parallel
Other design features
Our review of past studies showed that no similar studies have been conducted in this area.Therefore, this study can provide new results on the effect of probiotics on systemic lupus erythematosus disease.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mshhad University of medical Sciences
Street address
Ferdowsi University of Medical Sciences , Azadi Sq, Mashhad-Iran
City
mashhad
Province
Razavi Khorasan
Postal code
9177948564
Approval date
2020-12-28, 1399/10/08
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1399.577

Health conditions studied

1

Description of health condition studied
SLE( Systemic lupus erythematosus )
ICD-10 code
ICD-10 code description
kinds of autoimmune diseases

Primary outcomes

1

Description
IL17, Evaluation of FOXP3, T-bet, GATA-3 and ROR γt transcription factor gene expression by SYBR Green real-time RT-PCR method
Timepoint
Before intervention, 4 months after intervention
Method of measurement
Elisa test, SYBR Green real-time RT-PCR

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In addition to common therapies, one oral probiotic FamiLact 2plus daily includes the strains of Lactobacillus acidophilus, Lactobacillus casei, Lactobacillus rhamnosus, Lactobacillus salivarius, Lactobacillus reuteri, Bifidobacterium lactis, Bifidobacterium longum, Bifidobacterium bifidum. The duration of the intervention is 4 months. FamiLact 2Plus is from Zist Takhmir Company, made in Iran.
Category
Treatment - Drugs

2

Description
Control group: In addition to common treatments, one placebo is given daily.The duration of the intervention is 4 months. The placebo is from Zist Takhmir Company, made in Iran.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam Reza hospital
Full name of responsible person
Doctor Seyedeh Zahra Mirfeizi
Street address
Rheumatology Research Center of Imam Reza, mashhad city Hospital
City
mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2000
Email
mirfeiziz@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Doctor Mohsen Tafaghodi
Street address
faculty of medical, Mashhad Ferdowsi University, Ferdowsi square, Mashhad city
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2000
Email
mirfeiziz@mums.ac.ir
Grant name
Mashhad University of Medical Sciences
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
Arezoo Faridzadeh
Position
MD-Ph.D candidate
Latest degree
Medical doctor
Other areas of specialty/work
Immunology
Street address
Department of Immunology، faculty of medical, Mashhad Ferdowsi University, Ferdowsi square, Mashhad city
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2000
Email
Faridzadeha961@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Arezoo Faridzadeh
Position
medical doctor
Latest degree
Medical doctor
Other areas of specialty/work
Immunology
Street address
Department of Immunology، faculty of medical, Mashhad Ferdowsi University, Ferdowsi square, Mashhad city
City
mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2000
Email
Faridzadeha961@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Arezoo faridzadeh
Position
medical doctor
Latest degree
Medical doctor
Other areas of specialty/work
Immunology
Street address
Department of Immunology، faculty of medical, Mashhad Ferdowsi University, Ferdowsi square, Mashhad city
City
mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2000
Email
faridzadeha961@mums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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