Clinical and metabolic response to probiotic supplementation in patients with multiple sclerosis: A randomized, double-blind, placebo-controlled trial.
This trial was performed to evaluate the effects of probiotic intake on disability, mental health and metabolic condition in subjects with multiple sclerosis (MS).



This randomized double-blind placebo-controlled clinical trial was conducted among 60 MS patients. Participants were randomly allocated into two groups to receive either a probiotic capsule (n = 30) or placebo containing starch (n = 30) for 12 weeks. Expanded disability status scale (EDSS) scoring and parameters of mental health were recorded at the baseline and 12 weeks after the intervention.



Compared with the placebo, probiotic intake improved EDSS (-0.3 ± 0.6 vs. +0.1 ± 0.3, P = 0.001), beck depression inventory (-5.6 ± 4.9 vs. -1.1 ± 3.4, P < 0.001), general health questionnaire (-9.1 ± 6.2 vs. -2.6 ± 6.4, P < 0.001) and depression anxiety and stress scale (-16.5 ± 12.9 vs. -6.2 ± 11.0, P = 0.001). In addition, changes in high-sensitivity C-reactive protein (-1.3 ± 3.5 vs. +0.4 ± 1.4 μg/mL, P = 0.01), plasma nitric oxide metabolites (+1.0 ± 7.9 vs. -6.0 ± 8.3 μmol/L, P = 0.002) and malondialdehyde (MDA) (+0.009 ± 0.4 vs. +0.3 ± 0.5 μmol/L, P = 0.04) in the probiotic group were significantly different from the changes in these parameters in the placebo group. Additionally, the consumption of probiotic capsule significantly decreased serum insulin (-2.9 ± 3.7 vs. +1.1 ± 4.8 μIU/mL, P < 0.001), homeostasis model of assessment-estimated insulin resistance (-0.6 ± 0.8 vs.+0.2 ± 1.0, P = 0.001), Beta cell function (-12.1 ± 15.5 vs. +4.4 ± 17.5, P < 0.001) and total-/HDL-cholesterol (-0.1 ± 0.3 vs.0.1 ± 0.3, P = 0.02), and significantly increased quantitative insulin sensitivity check index (+0.01 ± 0.02 vs. -0.005 ± 0.01, P < 0.001) and HDL-cholesterol levels (2.7 ± 3.4 vs. 0.9 ± 2.9 mg/dL, P = 0.02) compared with the placebo.



Our study demonstrated that the use of probiotic capsule for 12 weeks among subjects with MS had favorable effects on EDSS, parameters of mental health, inflammatory factors, markers of insulin resistance, HDL-, total-/HDL-cholesterol and MDA levels.
Department of Neurology, School of Medicine, Kashan University of Medical Sciences, Kashan, Islamic Republic of Iran; Physiology Research Center, Kashan University of Medical Sciences, Kashan, Islamic Republic of Iran.
Ebrahim
E
Kouchaki
Physiology Research Center, Kashan University of Medical Sciences, Kashan, Islamic Republic of Iran.
Omid Reza
OR
Tamtaji
Physiology Research Center, Kashan University of Medical Sciences, Kashan, Islamic Republic of Iran. Electronic address: salami-m@kaums.ac.ir.
Mahmoud
M
Salami
Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Islamic Republic of Iran.
Fereshteh
F
Bahmani
Department of Neurology, School of Medicine, Kashan University of Medical Sciences, Kashan, Islamic Republic of Iran.
Reza
R
Daneshvar Kakhaki
Physiology Research Center, Kashan University of Medical Sciences, Kashan, Islamic Republic of Iran.
Elmira
E
Akbari
Faculty Member of Science Department, Science Faculty, Islamic Azad University, Tehran Central branch, Tehran, Islamic Republic of Iran.
Maryam
M
Tajabadi-Ebrahimi
Department of Microbiology, Science Faculty, Islamic Azad University, Arak branch, Arak, Islamic Republic of Iran.
Parvaneh
P
Jafari
Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Islamic Republic of Iran. Electronic address: asemi_r@yahoo.com.
Zatollah
Z
Asemi
D000293:Adolescent; D000328:Adult; D015415:Biomarkers / Q000097:blood; D001786:Blood Glucose / Q000378:metabolism; D002097:C-Reactive Protein / Q000378:metabolism; D002784:Cholesterol / Q000097:blood; D019587:Dietary Supplements; D004311:Double-Blind Method; D005260:Female; D005978:Glutathione / Q000097:blood; D006706:Homeostasis; D006801:Humans; D007328:Insulin / Q000097:blood; D007333:Insulin Resistance; D008297:Male; D008315:Malondialdehyde / Q000097:blood; D008875:Middle Aged; D009103:Multiple Sclerosis / Q000097:blood / Q000628:therapy*; D009569:Nitric Oxide / Q000097:blood; D018384:Oxidative Stress / Q000187:drug effects; D019936:Probiotics / Q000008:administration & dosage*; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D055815:Young Adult
D015415:Biomarkers; D001786:Blood Glucose; D007328:Insulin; D009569:Nitric Oxide; D008315:Malondialdehyde; D002097:C-Reactive Protein; D002784:Cholesterol; D005978:Glutathione
Disability; Inflammation; Multiple sclerosis; Oxidative stress; Probiotic