Protocol summary
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Study aim
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he aim of this study is to determine the effects of probiotic supplementation on disease severity and metabolic profiles 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.
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Settings and conduct
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60 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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Peoples will be entered in the study if they will be at ages between 18 and 55 with clinically definite RRMS will be diagnosed according to McDonald criteria and an expanded disability status scale (EDSS) score ≤4.5. The participants will be excluded from the study under following conditions: women who were pregnant or lactating during the past six months, patients bearing nephrolithiasis for the past 5 years, menopaused women with irregular menstruation and unwillingness to utilize appropriate contraceptive tools.
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Intervention groups
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Patients will be assigned to receive either probiotic supplements (intervention group: n=30) and placebo (control group: n=30).
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Main outcome variables
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Fasting blood samples will be taken at baseline and after 12-wk intervention. Disease severity and metabolic profiles will be meseaured 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:
IRCT201511015623N59
Registration date:
2015-12-02, 1394/09/11
Registration timing:
retrospective
Last update:
2019-09-23, 1398/07/01
Update count:
1
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Registration date
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2015-12-02, 1394/09/11
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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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2015-11-01, 1394/08/10
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Expected recruitment end date
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2015-12-01, 1394/09/10
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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 metabolic profiles 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:
Ages between 18 and 55
The course of RRMS diagnosed according to McDonald criteria
EDSS score ≤4.5
Exclusion criteria:
Women who were pregnant
Lactating during the past six months
Nephrolithiasis for the past 5 years
Menopaused women with irregular menstruation
Unwillingness to utilize appropriate contraceptive tools.
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Age
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From 18 years old to 55 years old
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Gender
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Both
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Phase
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2
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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:
60
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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 = 30) or placebo (n = 30). 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 Clinic of Shahid Beheshti Hospital , 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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Ethics committees
1
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Ethics committee
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Approval date
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2015-10-28, 1394/08/06
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Ethics committee reference number
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IR.Kaums.REC.1394.81
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 12 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 12 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 12 weeks of intervention
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Method of measurement
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Elisa kit
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 12 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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Triglycerides
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Enzymatic kit
4
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Description
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HDL-cholesterol
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Enzymatic kit
5
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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 12 weeks of intervention
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Method of measurement
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Spectrophotometry
6
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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 12 weeks of intervention
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Method of measurement
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Spectrophotometry
7
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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 12 weeks of intervention
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Method of measurement
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Spectrophotometry
8
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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 12 weeks of intervention
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Method of measurement
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Spectrophotometry
9
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Description
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Insulin resistance
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Timepoint
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At the beginning of the study and after 12 weeks of intervention
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Method of measurement
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Calculation using HOMA formula
10
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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 12 weeks of intervention
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Method of measurement
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Standard questionnaire GHQ-28
11
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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 12 weeks of intervention
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Method of measurement
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depression, anxiety and stress scale
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 12 weeks of intervention
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Method of measurement
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Beck Depression Inventory
Intervention groups
1
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Description
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Intervention group: Probiotic capsule containing four strains of Lactobacillus acidophilus (2×109 CFU/g), Lactobacillus casei (2×109 CFU/g), Bifidobacterium bifidum (2×109 CFU/g) and Lactobacillus fermentum (2×109 CFU/g), daily, for 12 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 12 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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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