Abstract
Introduction: 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 endpoint was the Physical, Psychological, and Social Fatigue Index derived from the Comprehensive Fatigue Assessment Battery for Multiple Sclerosis (CFAB-MS). Secondary outcomes included general health assessed by visual analogue scales (VAS) and other CFAB-MS domains, including pain, mood, stress, sleep, anxiety, nutrition, mobility, environment, and fatigue management.
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 Physical, Psychological, and Social Fatigue Index (Effect size (r)=-0.087; P-value=0.50) or most secondary outcomes between groups (P>0.05). Analysis of covariance (ANCOVA), with baseline values score as a covariate was not associated with a significant outcome (P-value>0.05). After applying the Benjamini–Hochberg correction for multiple comparisons, no effect remained statistically significant.
Conclusion: The findings suggest that routine use of multi-strain probiotic supplementation for fatigue management in patients with RRMS and EDSS<4 cannot be recommended. Future randomized trials with longer follow-up, dietary control, and integrated microbiome and inflammatory biomarker assessments are warranted.