Protocol summary
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Study aim
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The aim of this study is to determine the effects of probiotic supplementation on disease severity, mental health, insulin resistance, inflammatory factors and biomarkers of oxidative stress in patients with multiple sclerosis.
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Design
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Parallel double-blind (both patients and researchers) randomized controlled clinical trial. Random assignment will be done by the use of computer-generated random numbers. 48 patients with multiple sclerosis of eligible in the study will be selected. Patients will be assigned to receive either probiotic supplements and placebo. Fasting blood samples will be taken at baseline and after 16-wk intervention.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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The inclusion criteria were patients with ages between 20 and 60, course of disease relapsing–remitting MS (RRMS), identified according to McDonald criteria and an expanded disability status scale (EDSS) score ≤4.5 referred to the Neurology Clinic of Shahid Beheshti Hospital in Kashan city, Iran. The exclusion criteria were primary progressive MS (PPMS), secondary progressive MS (SPMS), clinical relapse and glucocorticoid therapy during the past one month, pregnancy, women who were lactating within the prior six month, patients with bearing nephrolithiasis within the prior five years and consumers of probiotic or synbiotic during the past three month.
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Intervention groups
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Patients will be assigned to receive either probiotic supplements (intervention group: n=24) and placebo (control group: n=24).
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Main outcome variables
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Disease severity, mental health, insulin resistance, inflammatory factors and biomarkers of oxidative stress will be measured at study baseline and end-of-trial
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT2017082234497N2
Registration date:
2017-09-15, 1396/06/24
Registration timing:
registered_while_recruiting
Last update:
2019-09-14, 1398/06/23
Update count:
1
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Registration date
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2017-09-15, 1396/06/24
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Vice chancellor for research, Kashan University of Medical Sciences
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Expected recruitment start date
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2017-08-17, 1396/05/26
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Expected recruitment end date
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2017-09-17, 1396/06/26
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Clinical trial of the effect of probiotic supplementation compared with the placebo on disease severity, mental health, insulin resistance, inflammatory factors and biomarkers of oxidative stress in patients with multiple sclerosis
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Public title
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Effect of supplementation in treatment of patients with multiple sclerosis
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patients with multiple sclerosis identified according to McDonald criteria
Course of disease relapsing–remitting MS (RRMS)
EDSS ≤4.5
Exclusion criteria:
Primary progressive MS (PPMS)
Secondary progressive MS (SPMS)
Relapse and glucocorticoid therapy during the past one month
Pregnancy
Women who were lactating within the prior six month
Nephrolithiasis
Consumption of of probiotic or synbiotic during the past three month
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Age
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From 20 years old to 60 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Investigator
- Outcome assessor
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Sample size
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Target sample size:
48
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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 = 24) or placebo (n = 24). Randomization will be done by the use of computer-generated random numbers.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Random assignment will be done by the use of computer-generated random numbers.
Ethics committees
1
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Ethics committee
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Approval date
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2017-08-16, 1396/05/25
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Ethics committee reference number
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IR.Kaums.MEDNT.REC.1396.28
Health conditions studied
1
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Description of health condition studied
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Multiple sclerosis
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ICD-10 code
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G35
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ICD-10 code description
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Multiple sclerosis
Primary outcomes
1
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Description
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EDSS
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Timepoint
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At the beginning of the study and after 16 weeks of intervention
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Method of measurement
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Physical Examination by Neurologist
2
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Description
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high sensitivity C-reactive protein
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Timepoint
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At the beginning of the study and after 16 weeks of intervention
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Method of measurement
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Elisa kit
Secondary outcomes
1
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Description
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Insulin
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Timepoint
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At the beginning of the study and after 16 weeks of intervention
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Method of measurement
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ELISA
2
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Description
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Fasting blood sugar
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Timepoint
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At the beginning of the study and after 16 weeks of intervention
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Method of measurement
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Enzymatic kit
3
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Description
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Nitric oxide
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Timepoint
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At the beginning of the study and after 16 weeks of intervention
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Method of measurement
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Spectrophotometry
4
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Description
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Interleukin 6
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Timepoint
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At the beginning of the study and after 16 weeks of intervention
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Method of measurement
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ELISA kit
5
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Description
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Interleukin 10
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Timepoint
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At the beginning of the study and after 16 weeks of intervention
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Method of measurement
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ELISA kit
6
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Description
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Tumor necrosis factor alpha
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Timepoint
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At the beginning of the study and after 16 weeks of intervention
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Method of measurement
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ELISA kit
7
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Description
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8-hydroxydeoxyguanosine
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Timepoint
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At the beginning of the study and after 16 weeks of intervention
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Method of measurement
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ELISA kit
8
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Description
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Superoxide dismutase
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Timepoint
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At the beginning of the study and after 16 weeks of intervention
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Method of measurement
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ELISA kit
9
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Description
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Glutathione
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Timepoint
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At the beginning of the study and after 16 weeks of intervention
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Method of measurement
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Spectrophotometry
10
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Description
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Malondialdehyde
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Timepoint
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At the beginning of the study and after 16 weeks of intervention
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Method of measurement
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Spectrophotometry
11
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Description
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Total antioxidant capacity
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Timepoint
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At the beginning of the study and after 16 weeks of intervention
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Method of measurement
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Spectrophotometry
12
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Description
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Depression
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Timepoint
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At the beginning of the study and after 16 weeks of intervention
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Method of measurement
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Beck Depression Inventory
13
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Description
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General Health
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Timepoint
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At the beginning of the study and after 16 weeks of intervention
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Method of measurement
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General Health Questionnaire (28 item)
14
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Description
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Depression
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Timepoint
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At the beginning of the study and after 16 weeks of intervention
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Method of measurement
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depression, anxiety and stress scale
Intervention groups
1
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Description
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Intervention group: Probiotic capsule containing four strains of Bifidobacterium infantis (2×109 CFU/g), Lactobacillus reuteri (2×109 CFU/g), Lactobacillus casei (2×109 CFU/g), lactobacillus plantarum (2×109 CFU/g), lactobacillus fermentum (2×109 CFU/g), and bifidobacterium lactis (2×109 CFU/g), daily, for 16 weeks orally.
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Category
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Treatment - Drugs
2
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Description
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Control group: Placebo capsule, daily, for 16 weeks orally.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Vice chancellor for research, Kashan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available