Probiotic supplementation and systemic inflammation in relapsing-remitting ۱ multiple sclerosis: A randomized, double-blind, placebo-controlled trial

Background and purpose: Multiple sclerosis (MS) is a complex inflammatory disease in which demyelination occurs in the central nervous system affecting approximately ۲.۵ million people worldwide. Intestinal microbiome changes play an important role in the etiology of chronic diseases. This study aimed to investigate the effect of probiotic supplementation on systemic inflammation in patients with MS. Materials and methods: A ۱۲-week double-blind clinical trial study was designed and seventy patients with MS were randomly divided into two groups receiving probiotics and placebo. Patients in the intervention group received two capsules containing multi-strain probiotics 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 the study.Results: Sixty-five patients were included in the final analysis. There was no significant difference between the two groups in terms of baseline variables except for the duration of the disease (P>۰.۰۵). At the end of the study, probiotic supplementation compared to the placebo 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, ۲۹ P<۰.۰۰۱). Also, we found a significant increase in the FOXP۳ and TGF-β levels in the ۳۰ intervention group (P<۰.۰۵). Conclusion: The results of our study showed that supplementation with probiotics can have beneficial effects on serum levels of some factors associated with systemic inflammation. Trial registration: Approved by the Ethics Committee of the Ahwaz Jundishapur University of Medical Sciences, Ahvaz, Iran. This study was registered within Iranian Registry of Clinical ۳۵ Trials (IRCT) ( http://www.irct.ir) under the number IRCT۲۰۱۸۱۲۱۰۰۴۱۹۱۸N۱

Keywords:

Probiotic , Multiple Sclerosis , Inflammation , Clinical Trial