IRCT2017082234497N2 IRCT 2017-09-15 Vice chancellor for research, Kashan University of Medical Sciences Effect of supplementation in treatment of patients with multiple sclerosis 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 2017-08-17 anticipated 48 Complete https://irct.ir/trial/26351 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Random assignment will be done by the use of computer-generated random numbers, 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 = 24) or placebo (n = 24). Randomization will be done by the use of computer-generated random numbers, 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. 3 Multiple sclerosis. Intervention 1: 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. Intervention 2: Control group: Placebo capsule, daily, for 16 weeks orally. 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 Undecided - It is not yet known if there will be a plan to make this available