Effect of synbiotics on disease activity and frequency of Th17 cells and Treg cells in Behcet patients
Design
ِDouble-blinded clinical trial with control group, with parallel groups, randomized. Patients were randomly assigned into two groups of control (n=14) receiving placebo capsules and treated group (n=14) receiving synbiotics capsules
Settings and conduct
In this study, the patients with Behcet's syndrome is studied. These individuals are selected randomly from among referrals to rheumatologist at Tabriz University of Medical Sciences, based on laboratory findings and medical records content. The treatment group will receive synbiotics. The control group will also receive placebo capsules.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 20-60 years Diagnosis of Behcet's disease by rheumatologist Selection of patients based on IBCD (International Criteria for Behcet's Disease), suggests that vascular, eye and joints threatening conflicts indicate severity of disease Exclusion criteria: Using nutritional supplements and antioxidant and alpha-lipoic acid during a month before study; Pregnancy&lactation; History of diabetes and other chronic diseases; history of other autoimmune diseases; drug compliance rate<70% of supplemental intake; Smoking
Intervention groups
The treatment group will receive synbiotics . The control group will also receive placebo capsules.
Main outcome variables
In this study, the effect of synbiotics were investigated on the frequency of Treg calls and Th17 cells and disease activity in patients with Behcet disease compared with the control group.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240429061594N1
Registration date:2024-05-30, 1403/03/10
Registration timing:prospective
Last update:2024-05-30, 1403/03/10
Update count:0
Registration date
2024-05-30, 1403/03/10
Registrant information
Name
Ali Riazi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3475 1646
Email address
riazia@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-21, 1403/04/01
Expected recruitment end date
2024-10-22, 1403/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of synbiotics on disease activity and frequency of Th17 cells and Treg cells in Behcet patients
Public title
Effect of synbiotics in patients with Behcet's disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to cooperate
Diagnosis of Behcet's disease by rheumatologist
Exclusion criteria:
Use of nutritional supplements and antioxidant and alpha-lipoic acid during a month before the study
Pregnancy and lactation
History of diabetes and other chronic diseases
The history of other autoimmune diseases
compliance of supplemental intake less than 70% of supplement
Smoking
Age
From 20 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
28
Randomization (investigator's opinion)
Randomized
Randomization description
From among the patients who volunteer to participate in the study, 28 individuals will be selected by simple randomization. Randomization method: Blocking Randomization unit: individual stratification: age and sex .Random blocks of variable sizes 4 and 2 are prepared via the website https://www.sealedenvelope.com/simple-randomiser/v1/lists. The content of each block is sealed in an opaque envelope, and upon the patients' visits, one of the blocks is randomly selected. Depending on the sequence content, the individual is placed in one of the study arms. concealment: The generated random sequence will be kept in a protected location and administered by an independent party who is not involved in the trial throughout the study. Due to proper allocation concealment, trial investigators and participants will be unaware of upcoming allocations.
Blinding (investigator's opinion)
Double blinded
Blinding description
This is a double blind study in which the researcher and patients who participate in study will be blinded to the group assignments. The patients will receive the supplements by another person who is not involved in doing the assessment and chemical analysis. Patients will be informed about the type of supplements (synbiotic and placebo) however they will not be aware about the group assignments. Placebo capsules are identical to synbiotic supplements in shape and color and size.
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
Ethics committee,Vice chancellor for Research,Faculty of Medicine,Tabriz Univarsity of Medical Sciences,Golgasht st,Tabriz,Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5163996889
Approval date
2023-10-16, 1402/07/24
Ethics committee reference number
IR.TBZMED.REC.1402.539
2
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Ethics Committee,Vice Chancellor for Research,Faculty of Medicine,Tabriz Univarsity of Medical Sciences,Golgasht st,Tabriz,Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5163996889
Approval date
2023-10-16, 1402/07/24
Ethics committee reference number
IR.TBZMED.REC.1402.559
Health conditions studied
1
Description of health condition studied
Behcet disease
ICD-10 code
M35.2
ICD-10 code description
Behcet's disease
Primary outcomes
1
Description
Frequency of Th17 cells
Timepoint
Before and after intervention
Method of measurement
Flow cytometry
2
Description
Frequency of Treg cells
Timepoint
Before and after intervention
Method of measurement
Flow cytometry
3
Description
disease activity
Timepoint
Before and after intervention
Method of measurement
Iranian BD dynamic activity measure (IBDDAM) and BD current activity form (BDCAF) scores
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: synbiotic Patients in intervention group will take one synbiotic capsule by the name Fami Lact (including probiotic 9 10 CFU (colony-forming unit) plus prebiotics) by Zist Takhmir pharmaceutical company) with their lunch meal per day over a period of 16weeks.
Category
Treatment - Drugs
2
Description
Control group: Placebo Patients in control group will take one placebo capsule (produced by Zist Takhmir pharmaceutical company) with their lunch meal per day over a period of 16weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Ali Riazi
Street address
Emam Reza Hospital, Golgast st,Tabriz.
City
Tabriz
Province
East Azarbaijan
Postal code
566614766
Phone
+98 41 3334 4918
Email
nimariyazi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Parviz Shahabi
Street address
Vice chancellor for Research,Tabriz University of Medical Sciences, Golgasht Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5164886994
Phone
+98 41 3337 2084
Email
Shahabi_p@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
50
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
Ali Riazi
Position
Assisstant professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Internal Medicine Department,Emam Reza Hospital,Golgasht Avenue,Daneshgah Street
City
Tabriz
Province
East Azarbaijan
Postal code
5981764863
Phone
+98 41 3334 7054
Email
nimariyazi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ali Riazi
Position
Assisstant professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Internal Medicine Department,Emam Reza Hospital,Golgasht Avenue,Daneshgah Street
City
Tabriz
Province
East Azarbaijan
Postal code
5981764863
Phone
+98 41 3334 7054
Email
nimariyazi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ali Riazi
Position
Assisstant professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Internal Medicine Department,Emam Reza Hospital,Golgasht Avenue,Daneshgah Street
City
Tabriz
Province
East Azarbaijan
Postal code
5174666994
Phone
+98 41 3337 2084
Email
nimariyazi@gmail.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