Improvement in Expanded Disability Status Scale (EDSS) and anti-inflammatory parameters in patients with multiple sclerosis following oral consumption of N-163 strain of Aureobasidium pullulans produced beta glucan in a pilot clinical study

IntroductionMultiple Sclerosis (MS) is a debilitating neurodegenerative disease in which demyelination due to auto-inflammation is considered to be the underlying pathogenesis, though the exact etiology is not known. Most of the management strategies involve medications that are anti-inflammatory or immune-suppressive, which do have associated side effects. In this study we have evaluated in MS patients, the clinical effects of a novel beta-glucan which has a track record of anti-inflammatory, immune-modulating potentials in earlier clinical and pre-clinical studies. MethodThe study involved 12 MS patients who consumed two sachets of N-163 strain of Aureobasidium pullulans produced B-Glucan, daily for 60 days along with routine medication. ResultsThe Expanded Disability Status Scale (EDSS) improved by 0.5 in two patients and by 1 in one patient post-intervention, worsened in 1 patient, remaining stable in the rest. Decrease in IL-6, improvement in CD4+ve, CD19+ve, CD3+ve, and CD8+ ve cell count, increase in Lymphocyte to C-reactive protein ratio (LCR), Leukocyte to CRP ratio (LeCR) and a decrease in Neutrophil to Lymphocyte ratio (NLR) were observed. ConclusionThis study having proven the safety of N-163 strain of A.pullulans produced B-Glucan food supplement and the efficacy by improvement in the EDSS score, besides beneficial modulation of inflammation and immune parameters of relevance in MS patients in a short duration of 60 days, has significant potential as a disease modifying adjuvant in MS. Immunological parameters like NLR, LCR, LeCR correlating with clinical improvement, in line with earlier reports using the same beta-glucans, gain further significance for their potentials as biomarkers in MS.