Effect of synbiotic supplementation on disease activity, Th17 cells frequency, IL-23/IL-17 axis expression and serum levels of IL-17 and IL-23 in patients with ankylosing spondylitis
Determining the effect of synbiotic supplement on disease activity, Th17 frequency, IL-23/IL-17 axis expression and serum IL-17 and IL-23 levels in ankylosing spondylitis patients
Design
Clinical trial with control group, parallel groups, double blind, randomized
Settings and conduct
48 AS patients referred to rheumatology clinic are selected based on inclusion and exclusion criteria. Patients will be randomly divided into two groups receiving synbiotic (24) and receiving placebo (24). The study groups will receive one synbiotic capsule (zist-takhmir company) or placebo per day for 3 months. Participants and outcome assessors will be blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: willing to participate; age range 20-60 years; diagnosis of AS by a rheumatologist
Exclusion criteria: using nutritional and antioxidant supplements during one month prior to the study; pregnancy and lactation; history of having other autoimmune diseases; history of having diabetes and inflammatory bowel diseases; gastrointestinal system infections; recurrence of disease during the study
Intervention groups
Intervention group: receiving one synbiotic capsule per day for 3 months
Placebo group: receiving one placebo capsule per day for 3 months
Effect of synbiotic supplementation on disease activity, Th17 cells frequency, IL-23/IL-17 axis expression and serum levels of IL-17 and IL-23 in patients with ankylosing spondylitis
Public title
Effect of synbiotic supplementation in ankylosing spondylitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Willing to participate
Age range 20-60 years
AS diagnosis by rheumatologist
Exclusion criteria:
Taking nutritional and antioxidant supplements one month prior to study
Pregnancy and lactation
History of other autoimmune diseases
History of diabetes mellitus, IBD
Gastrointestinal infection and other chronic diseases
The recurrence of the disease during the study
Unwilling to continue the study
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
The selected samples will be randomly (block randomization) divided into two groups: synbiotic and placebo.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, care provider and investigator will be blind in this study. The way of participant blindness is that he will receive and use a certain number of drugs in an unnamed and labeled envelope. The way of care provider blindness is that after making diagnosis of ankylosing spondylitis to his patient and notifying his secretory, randomly gives one of the envelopes to the patient. The way of researcher's blindness is that he will not be present in the filling envelopes and selecting them by secretory.
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
Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614754
Approval date
2019-08-19, 1398/05/28
Ethics committee reference number
IR.TBZMED.REC.1398.591
Health conditions studied
1
Description of health condition studied
Ankylosing spondylitis
ICD-10 code
M45
ICD-10 code description
Ankylosing spondylitis
Primary outcomes
1
Description
disease activity
Timepoint
Before and after intervention
Method of measurement
BASDAI and BASFI criteria
2
Description
Th17 cells frequency
Timepoint
Before and after intervention
Method of measurement
Flow cytometry
3
Description
IL-23/IL-17 axis expression
Timepoint
Before and after intervention
Method of measurement
Real-time PCR and ELISA
4
Description
Serum IL-17 cytokine
Timepoint
Before and after intervention
Method of measurement
ELISA kit
5
Description
Serum IL-23 cytokine
Timepoint
Before and after intervention
Method of measurement
ELISA kit
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 1 synbiotic capsule fami lact per day for 3 months from Zist Takhmir factory capsuls include: 10 9 CFU bacteria namely Lactobacilus casei, Lactobacilus Ramnosis, Lactobacilus acidophilus, Lactobacillus bolgaricus, streptococus thermophillus, bifidobacterium Langom and froctooligosacharide (FOS) prebiotic
Category
Treatment - Other
2
Description
Placebo group: 1 placebo capsule per day including corn starch from Zist Takhmir factory for 3 months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz Imam-Reza Hospital
Full name of responsible person
Masoud Ahangari Maleki
Street address
Golgasht
City
Tabriz
Province
East Azarbaijan
Postal code
5166614754
Phone
+98 41 3336 9331
Email
ahangari2200@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Samiei
Street address
Golgasht
City
Tabriz
Province
East Azarbaijan
Postal code
5166614754
Phone
+98 41 3335 7310
Email
Samiei.moh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
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
Aida Malek Mahdavi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Golgasht
City
Tabriz
Province
East Azarbaijan
Postal code
5166614754
Phone
+98 41 3336 9331
Email
amalek@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Aida Malek Mahdavi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Golgasht
City
Tabriz
Province
East Azarbaijan
Postal code
5166614754
Phone
+98 41 3336 9331
Email
amalek@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Aida Malek Mahdavi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Golgasht
City
Tabriz
Province
East Azarbaijan
Postal code
5166614754
Phone
+98 41 3336 9331
Email
amalek@tbzmed.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