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IRCT20161022030424N1 IRCT 2018-04-09 Tabriz University of Medical Sciences The effect of probiotic Saccharomyces Bulardi in Multiple Sclerosis (MS) The effect of probiotic Saccharomyces Bulardi on mental health, quality of life, fatigue, pain and indices of inflammation and oxidative stress in Multiple Sclerosis (MS) 2018-03-21 anticipated 50 Complete https://irct.ir/trial/29990 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomizations will be conducted by an assistant using permuted block randomization method and stratified randomization will be used to match participants based on age and body mass index, Blinding description: It would be impossible for research personnel involving with participants or analyzing the study results to adjust randomization or discern what product participants were receiving, ensuring true allocation concealment. The placebo is indistinguishable in color, smell and taste from the probiotic capsule. 1 Multiple Sclerosis. Intervention 1: Intervention group: Probiotic capsule containing 250 mg yeast of Saccharomyces bullaria (1010 CFU) and 100 mg of magnesium and lactose stearates daily after a meal, for 4 months manufactured by a TakGene Zist (Tehran, Iran). Intervention 2: Control group: Placebo capsule containing 100 mg of magnesium and lactose stearates daily after a meal, for 4 months manufactured by a TakGene Zist (Tehran, Iran). Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public Neda Dolatkhah
Azadi, Golgasht
Tabriz Iran (Islamic Republic of) 5163995479 +98 41 3336 1928 dolatkhahn@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Neda Dolatkhah
Physical Medicine and Rehabilitation Dept., Emam Reza Hospital, Golghasht, Azadi Ave.
Tabriz Iran (Islamic Republic of) 5166614756 +98 41 3336 1928 dolatkhahn@tbazmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Having a disease for more than a year Multiple sclerosis confirmed by a neurologist No other chronic diseases Lack of mental illness Not pregnant Not consuming probiotic foods from a month before the study 20 years 45 years Both Unwillingness to continue studying at each stage Consumption of any probiotic food during the study Acute gastrointestinal disease Antibiotic use during the study Acute and severe phase of MS G35 Multiple sclerosis Treatment - Drugs Treatment - Drugs Intervention group: Probiotic capsule containing 250 mg yeast of Saccharomyces bullaria (1010 CFU) and 100 mg of magnesium and lactose stearates daily after a meal, for 4 months manufactured by a TakGene Zist (Tehran, Iran) Control group: Placebo capsule containing 100 mg of magnesium and lactose stearates daily after a meal, for 4 months manufactured by a TakGene Zist (Tehran, Iran) Mental health. Timepoint: Determining mental health at the beginning of the study (before the intervention) and 2 and 4 months after starting the administration of probiotic or placebo supplementation. Method of measurement: General Health Questionnaire (GHQ-28). Quality of life. Timepoint: Determining quality of life at the beginning of the study (before the intervention) and 2 and 4 months after starting the administration of probiotic or placebo supplementation. Method of measurement: SF-36 quality of life questionnaire. Pain. Timepoint: Determining pain at the beginning of the study (before the intervention) and 2 and 4 months after starting the administration of probiotic or placebo supplementation. Method of measurement: visual analogue scale. Fatigue. Timepoint: Determining fatigue at the beginning of the study (before the intervention) and 2 and 4 months after starting the administration of probiotic or placebo supplementation. Method of measurement: fatigue severity scale (FSS). Hs-CRP inflammatory index. Timepoint: Determining hs-CRP inflammatory index at the beginning of the study (before the intervention) and 4 months after starting the administration of probiotic or placebo supplementation. Method of measurement: biochemical assay. Total antioxidant capacity (TAC). Timepoint: Determining total antioxidant capacity (TAC) at the beginning of the study (before the intervention) and 4 months after starting the administration of probiotic or placebo supplementation. Method of measurement: biochemical assay. Superoxide dismutase (SOD). Timepoint: Determining superoxide dismutase (SOD) at the beginning of the study (before the intervention) and 4 months after starting the administration of probiotic or placebo supplementation. Method of measurement: biochemical assay. Malondialdehyde (MDA). Timepoint: Determining malondialdehyde (MDA) at the beginning of the study (before the intervention) and 4 months after starting the administration of probiotic or placebo supplementation. Method of measurement: biochemical assay. Tabriz University of Medical Sciences Approved 2017-10-02 Regional Ethics Committee for Research (Human Subjects Studies) Tabriz University of Medical Science Emam Reza Hospital, Golgasht, Azadi Avenue. Tabriz East Azarbaijan Iran (Islamic Republic of)