Clinical trial of the effect of probiotic supplementation compared with the placebo on levels of gene expression related with glycemic control, lipid and inflammatory factors in patients with multiple sclerosis
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General information
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The updating process was done after publishing the paper to correct the registration information.
The updating process was done after publishing the paper to correct the registration information.
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پروسه بروزرسانی پس از انتشار مقاله به منظور تصحیح اطلاعات ثبت انجام گرفت.
Primary outcomes
#1
Interleukin 6
Interleukin 1
Interleukin 61
اینترلوکین-6
اینترلوکین-1
اینترلوکین-61
Protocol summary
Study aim
The aim of this study is to determine the effects of probiotic supplementation on levels of gene expression related with glycemic control, lipid and inflammatory factors in in patients with multiple sclerosis.
Design
Parallel double-blind (both patients and researchers) randomized controlled clinical trial
Settings and conduct
40 patients with multiple sclerosis of eligible and referred to Beheshti Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected
Participants/Inclusion and exclusion criteria
Patients with multiple sclerosis and aged 18 to 55 years will be included in this study. The participants will be excluded from the study under following conditions: women who were pregnant or lactating during the past six months, taking probiotic or synbiotic products, menopaused women with irregular menstruation and unwillingness to utilize appropriate contraceptive tools.
Intervention groups
Patients will be assigned to receive either probiotic (n=20) or placebo (n=20).
Main outcome variables
Levels of gene expression related with glycemic control, lipid and inflammatory factors
General information
Reason for update
The updating process was done after publishing the paper to correct the registration information.
Acronym
IRCT registration information
IRCT registration number:IRCT201609185623N88
Registration date:2016-09-27, 1395/07/06
Registration timing:retrospective
Last update:2023-04-03, 1402/01/14
Update count:2
Registration date
2016-09-27, 1395/07/06
Registrant information
Name
Zatollah Asemi
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1534 3570
Email address
asemi_z@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan University of Medical Sciences
Expected recruitment start date
2016-07-24, 1395/05/03
Expected recruitment end date
2016-07-31, 1395/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of the effect of probiotic supplementation compared with the placebo on levels of gene expression related with glycemic control, lipid and inflammatory factors in patients with multiple sclerosis
Public title
Effect of supplementation in treatment of patients with multiple sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with multiple sclerosis
Aged 18 to 55 years
Course of disease relapsing–remitting MS (RRMS)
EDSS ≤4.5
Exclusion criteria:
Pregnancy
Women who were lactating within the prior six month
Consumption of of probiotic or synbiotic
Menopaused women with irregular menstruation
Unwillingness to utilize appropriate contraceptive tools
Age
From 18 years old to 55 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
At study baseline and after stratification for pre-intervention BMI and age, subjects will be randomly divided into two groups to take either probiotic supplements (n = 20) or placebo (n = 20). Randomization will be done by the use of computer-generated random numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Shahid Beheshti Clinic, who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Ghotbe Ravandi Boulevard, Kashan
City
kashan
Province
Isfehan
Postal code
8715988141
Approval date
2016-07-23, 1395/05/02
Ethics committee reference number
IR.Kaums.REC.1395.42
Health conditions studied
1
Description of health condition studied
Multiple sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis
Primary outcomes
1
Description
Tumor necrosis factor alpha
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
PCR
2
Description
Interleukin 1
Timepoint
At the beginning of the study and after 12 weeks of intervention
Method of measurement
PCR
3
Description
Interleukin-8
Timepoint
At the beginning of the study and after 12 weeks of intervention