The effects of probiotics in functional abilities of multiple sclerosis patients: a randomized double-blind placebo-control trial

Abstract

Multiple sclerosis (MS) is a demyelinating inflammatory disease of the central nervous system that damages the myelin around axons and disrupts nerve conduction, leading to a wide range of symptoms including limb weakness, sensory symptoms, diplopia, ataxia, sphincter disorders, depression, and spasms. Fatigue and cognitive impairment are also common and debilitating symptoms of this disease that have a significant impact on the quality of life of patients. Probiotics, through the gut-brain axis, are suggested to improve the clinical condition in patients with MS. This study investigates the effects of probiotic supplements in patients with relapsing-remitting MS (RRMS).

Methods After obtaining the necessary ethical approvals from the esteemed Ethics Committee of Tabriz University of Medical Sciences and registering the study in the Iranian Registry of Clinical Trials (IRCT), in this parallel, randomized, double-blind, placebo-controlled clinical trial, 90 RRMS patients with an Extended Disability Status Scale (EDSS <4) received one of two study arms, probiotic (Lactocare®) or placebo, twice daily for four months. The outcomes assessed included the level of disability (based on EDSS), cognitive function (Symbolic Digit Methods Test [SDMT], Three-Second Version of the Auditory Serial Addition Test [PASAT-3]), depressive symptoms (Beck Depression Inventory-II [BDI]), patients' manual dexterity (Non-Hole Nail Test [9HPT]), and patients' fatigue status based on the Comprehensive Fatigue Assessment Battery for Multiple Sclerosis (CFAB-MS). Blinding was performed for outcome assessors and patients. All assessments were performed at baseline and after four months, and findings were compared between study groups.

Results In this study, 122 patients with MS were initially evaluated, and of the 90 randomized patients, 60 completed the trial, including 29 in the probiotic group and 31 in the placebo group. The mean age of the patients was 33.66±8.23 in the probiotic group and 31.23±8.85 in the placebo group. Of the total patients, 46 (76.6%) were female. Probiotic supplementation was not associated with significant improvement in EDSS, BDI-II, PASAT, SDMT, and 9HPT of the non-dominant hand (p-values>0.05). Within-group improvements in PASAT-3 (median change: 2 [IQR: 9.5]) and 9HPT dominant hand (median change: -0.43 [IQR: 2.15]) were observed in the probiotic supplementation group, which was similar to the placebo group.