Determining the intervention effect of synbiotic supplement on oxidative stress markers in systemic lupus
Design
The study is conducted on 76 patients with SLE who meet the criteria of SLE. Before the start of the study and after obtaining informed consent from all the participants, a questionnaire form was collected for the patients including name and surname, age, education, occupation, place of residence, height, weight and then from all the participants the amount of 5 CC venous blood sample will be taken to measure TAC, MDA and lipid profile. Then the patients were randomly divided into two groups of 38 case group and 38 control group using envelopes containing medicine and placebo (with codes A and B) and blinded by a medical student. Then after 8 weeks, again Clinical measurements are repeated and blood sampling is done again.
Settings and conduct
The study is carried out in an interventional way and on 76 patients with SLE referred to the rheumatology clinic of Imam Khomeini (RA) hospital in Ardabil who met the criteria of systemic lupus erythematosus according to the SLICC criteria.
Participants/Inclusion and exclusion criteria
Inclusion criteria include definitive diagnosis of SLE, age over 18 years, and exclusion criteria include antibiotic use, pregnancy, breastfeeding, uncontrolled blood pressure, suffering from other autoimmune diseases, diabetes or other endocrine disorders, severe kidney and liver disease, sensitivity to Synbiotic
Intervention groups
The case group will be given synbiotic capsules daily for 8 weeks and the control group will be given placebo medicine at the same time
Main outcome variables
MDA-TAC
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240510061723N1
Registration date:2024-06-20, 1403/03/31
Registration timing:registered_while_recruiting
Last update:2024-06-20, 1403/03/31
Update count:0
Registration date
2024-06-20, 1403/03/31
Registrant information
Name
Yousef mohammadikebaar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3325 1401
Email address
yousefmk506@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-20, 1403/02/31
Expected recruitment end date
2024-09-21, 1403/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effects of synbiotic supplementation on serum oxidative stress markers in systemic lupus erythematosus patients
Public title
The effect of synbiotic supplementation in systemic lupus erythematosus patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Definitive diagnosis of SLE
Age above 18 years
Exclusion criteria:
Taking antibiotics
pregnancy
breastfeeding
Uncontrolled blood pressure
Suffering from other autoimmune diseases
diabetes
Severe kidney and liver disease
Life-threatening SLE including lupus nephritis and CNS involvement
Lupus vasculitis
peritonitis
severe hemolysis
Platelets less than 40,000
Endocarditis
Alveolar hemorrhage
Lupus pneumonia
OCP intake
Taking supplements containing antioxidants or omega-3 in the last month
Sensitivity to synbiotics
Smoking and alcohol consumption
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
76
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Randomization is simple. The unit of randomization is individual. The table of random numbers is used for randomization.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ardabil University of Medical Sciences
Street address
Ardabil University of Medical Sciences administrative complex-At the end of University Street
City
Ardebil
Province
Ardabil
Postal code
8599156189
Approval date
2024-04-16, 1403/01/28
Ethics committee reference number
IR.ARUMS.REC.1403.001
Health conditions studied
1
Description of health condition studied
Systemic lupus erythematosus
ICD-10 code
M32
ICD-10 code description
Systemic lupus erythematosus (SLE)
Primary outcomes
1
Description
Total antioxidant capacity: measures the antioxidant capacity. Malondialdehyde: shows the level of oxidative stress.
Timepoint
At the beginning of the study and then 8 weeks after taking drugs and placebo
Method of measurement
The level of (MDA) and (TAC) in serum samples is measured using a spectrophotometer with a colorimetric method.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: They received synbiotic capsules for 8 weeks.
Category
Treatment - Drugs
2
Description
Control group: received placebo for 8 weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini hospital
Full name of responsible person
Yusef Mohammadi Kabar
Street address
Ardabil province, Ardabil, 18 meters, Azadegan, Shahid Ghafoor Jedi street
City
Ardebil
Province
Ardabil
Postal code
5619647531
Phone
+98 45 3325 1401
Email
emam.lib@arums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Farhad Pourfarzi
Street address
Ardabil University of Medical Sciences administrative complex,At the end of University Street
City
Ardebil
Province
Ardabil
Postal code
۵۶۱۸۹-۸۵۹۹۱
Phone
+98 45 3353 4790
Fax
+98 45 3353 4773
Email
portal@arums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardabil 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
Ardabil University of Medical Sciences
Full name of responsible person
yousef mohammadi kebar
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Rheumatology
Street address
No.58-Parsa Building -Molvi St. -Artesh Square
City
Ardebil
Province
Ardabil
Postal code
1385327471
Phone
+98 45 3372 5254
Email
y.mohammadikebar@arums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
yousef mohammadi kebar
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Rheumatology
Street address
No.58-Parsa Building-Molvi St. -Artesh Square
City
Ardebil
Province
Ardabil
Postal code
1385327471
Phone
+98 45 3372 5254
Email
y.mohammadikebar@arums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Yusuf Mohammadi Kabar
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Rheumatology
Street address
No.58-Parsa Building -Molvi St.-Artesh Square
City
Ardebil
Province
Ardabil
Postal code
1385327471
Phone
+98 45 3372 5254
Email
y.mohammadikebar@arums.ac.ir
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