Probiotic supplementation and systemic inflammation in relapsingremittingmultiple sclerosis: A randomized, double-blind, placebocontrolledtrial

Background and purpose: Multiple sclerosis (MS) is a complex inflammatory disease inwhich demyelination occurs in the central nervous system affecting approximately ۲.۵million people worldwide. Intestinal microbiome changes play an important role in theetiology of chronic diseases. This study aimed to investigate the effect of probioticsupplementation on systemic inflammation in patients with MS.Materials and methods: A ۱۲-week double-blind clinical trial study was designed andseventy patients with MS were randomly divided into two groups receiving probiotics andplacebo. Patients in the intervention group received two capsules containing multi-strainprobiotics daily and patients in the control group received the same amount of placebo.Factors associated with systemic inflammation were assessed at the beginning and end of thestudy.Results: Sixty-five patients were included in the final analysis. There was no significantdifference between the two groups in terms of baseline variables except for the duration ofthe disease (P>۰.۰۵). At the end of the study, probiotic supplementation compared to theplacebo caused a significant reduction in the serum levels of CRP (-۰.۹۳± ۱.۶۲ vs. ۰.۰۵ ±۱.۷۴, P=۰.۰۳), TNF-α ( -۲.۰۹ ± ۱.۸۸ vs. ۰.۴۸ ± ۲.۵۳, P=۰.۰۱۵) and IFN-γ (-۱۳.۱۸± ۷.۳۳ vs. -۱.۹۳± ۵.۹۹, P<۰.۰۰۱). Also, we found a significant increase in the FOXP۳ and TGF-β levelsin the intervention group (P<۰.۰۵).Conclusion: The results of our study showed that supplementation with probiotics can havebeneficial effects on serum levels of some factors associated with systemic inflammation.Trial registration: Approved by the Ethics Committee of the Ahwaz Jundishapur Universityof Medical Sciences, Ahvaz, Iran. This study was registered within Iranian Registry ofClinical Trials (IRCT) ( http://www.irct.ir) under the number IRCT۲۰۱۸۱۲۱۰۰۴۱۹۱۸N۱.

Keywords:

Probiotic , Multiple Sclerosis , Inflammation , Clinical Trial