Effects of Probiotics Supplementation on General Health, Fatigue, and Its Related Factors in Patients with Relapsing-Remitting Multiple Sclerosis: A Randomized, Double-Blind, Placebo-Controlled Trial

Abstract

Background: Fatigue is one of the most debilitating and least understood symptoms of multiple sclerosis (MS). This study aimed to evaluate the effects of probiotics supplementation on general health, fatigue, and its related factors in patients with relapsing-remitting MS (RRMS).Methods: In this double-blind, randomized, placebo-controlled trial, 90 RRMS patients with Expanded Disability Status Scale (EDSS)<4 were enrolled. Participants received a multi-strain probiotics supplement (Lactocare®) or placebo for 16 weeks. The primary outcome was fatigue and its related factors including pain, mood, stress, sleep, anxiety, nutrition, mobility, environment, and fatigue management skills. The secondary outcome of this RCT was general health status based on the visual analog scales (VAS). Outcomes were assessed using the Comprehensive Fatigue Assessment Battery for MS (CFAB-MS). All assessments were conducted at baseline and after four months.Results: Out of 90 randomized patients, 60 completed the trial (29 in the probiotics group and 31 in the placebo group). Probiotics supplementation did not result in statistically significant differences in fatigue or most secondary outcomes between groups (p>0.05). However, the within-group analysis showed significant improvements in VAS for fatigue (p=0.04) and nutrition index (p=0.02) in the probiotics group. The placebo group exhibited greater within-group improvements in stress (p=0.01), and anxiety and worry (p=0.01) indices.Conclusions: Supplementation with a multi-strain probiotics product for four months does not result in significant improvements in fatigue and its related factors in RRMS patients with EDSS<4.

Keywords: multiple sclerosis, probiotics, fatigue, randomized controlled trial