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IRCT20220713055465N2 IRCT 2023-05-09 Tabriz University of Medical Sciences Probiotic supplementation in multiple sclerosis Investigating the effect of probiotic supplementation compared to placebo on serum oxidative stress factors in patients with multiple sclerosis (MS) 2022-08-23 anticipated 90 Complete https://irct.ir/trial/69671 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Table of random numbers. In this method, each person participating in the study is assigned a number (from 1 to 90; according to the sample size) and a subset of the population is randomly selected using a table of random numbers. Even numbers are assigned to the intervention group and odd numbers to the placebo group, Blinding description: The examiner, patient and data analyst will not know the type of intervention received by the patient. Capsules of the same shape containing the placebo or probiotic supplement will be delivered to the patients in identically packaged containers. 2 Multiple Sclerosis. Intervention 1: Intervention group: LactoCare probiotic supplement that contains high amounts of 12 beneficial and safe bacterial strains along with fructooligosaccharides as prebiotics. Patients will take this supplement once daily and oral for 4 months. Intervention 2: Control group: placebo. This capsule contains an ineffective substance (starch powder) that patients will take once daily for 4 months. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Mahnaz Talebi
Golgasht
Tabriz Iran (Islamic Republic of) 5166614756 +98 41 3334 0730 Talebi511@yahoo.com Tabriz University of Medical Sciences scientific Mahnaz Talebi
Golgasht
Tabriz Iran (Islamic Republic of) 5166614756 +98 41 3334 0730 Talebi511@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Definitive diagnosis of multiple sclerosis based on 2017 MacDonald criteria Relapsing Remitting MS (RRMS) Informed consent to participate in the study no limit no limit Both The presence of other neurological diseases at the same time as MS Diabetes mellitus (DM) Anemia Other inflammatory diseases Rheumatological diseases Acute and chronic infectious diseases (including urinary tract infection) Discopathy Relapsing of the disease in the last 4 months Receiving pulse coronet during the last 4 months Progressive MS CIS (Clinically isolated syndrome) Literacy level below 12 years and lack of proficiency in Persian language Severe depression and use of antidepressants Alcohol or drug abuse Thyroid disorders Taking drugs that affect fatigue Pregnancy G35 Multiple Sclerosis Treatment - Drugs Placebo Intervention group: LactoCare probiotic supplement that contains high amounts of 12 beneficial and safe bacterial strains along with fructooligosaccharides as prebiotics. Patients will take this supplement once daily and oral for 4 months. Control group: placebo. This capsule contains an ineffective substance (starch powder) that patients will take once daily for 4 months. Oxidative stress markers including MDA، SOD، ATC، GSH، GPX1 و GPX2. Timepoint: Baseline and end of treatment period. Method of measurement: Based on serum samples of the patients. Tabriz University of Medical Sciences Approved 2022-11-21 Ethics Committee of Tabriz University of Medical Sciences Gogasht Tabriz East Azarbaijan Iran (Islamic Republic of)