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Study aim: 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. Design: 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. Settings and conduct: 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. Participants/Inclusion and exclusion criteria: 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. Intervention groups: Patients will be assigned to receive either probiotic supplements (intervention group: n=24) and placebo (control group: n=24). Main outcome variables: Disease severity, mental health, insulin resistance, inflammatory factors and biomarkers of oxidative stress will be measured at study baseline and end-of-trial
IRCTID: IRCT2017082234497N2
  1. Clinical trial of the effect of combined probiotic and selenium supplementation compared with the placebo on insulin resistance, inflammatory factors, biomarkers of oxidative stress and cognitive function in patients with Alzheimer's disease
  2. Clinical trial of the effect of combined omega-3 and vitamin D supplementation compared with the placebo on clinical and metabolic status in patients with multiple sclerosis
  3. Study of the effect of magnesium and zinc and probiotic co-supplementation on metabolic profiles in patients with coronary heart disease and type 2 diabetes mellitus
  4. Clinical trial of the effect of omega-3 plus vitamin E supplementation compared with the placebo on disease severity and metabolic profiles in patients with Parkinson's
  5. 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)
  6. Clinical trial of the effect of probiotic supplementation compared with the placebo on metabolic profiles in patients with Parkinson's
  7. Effect of calcium and vitamin D co-supplementation on insulin resistance and inflammatory factors in women with gestational diabetes
  8. The effect of magnesium and zinc co-supplementation on metabolic profiles in patients with coronary heart disease and type 2 diabetes mellitus
  9. Effect of soy-protein consumption on insulin resistance, inflammatory factor, biomarkers of oxidative stress and pregnancy outcomes in gestational diabetes
  10. Investigating the effect of guided mental imagery on motor dysfunction and balance of patients with multiple sclerosis (MS)
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