Study Design : Open Label, Prospective, Non-Randomised, Non-Comparative Single Arm Clinical Study

Indication : Multiple Sclerosis

Investigational Product : N163 Beta Glucan

Comparator: None.   

Dose : 1 sachet of  Beta Glucan N-163 to be consumed with water 30 minutes after meal; once in the morning and once in evening

Dosage : Two Sachets per day for 60 days

Subject Population : Adults aged ≥21 years of age, all genders inclusive; with  diagnosis/history of MS.

Number of Subjects : 20 Evaluable Subjects

Treatment Arms : One. Single Arm

Treatment Duration : 60 days.

Assessments

a.         CRP

b.         ESR

c.         CD56

d.         CD16+Immune Cells

e.         CD4

f.          CD8

g.         CD3 + T Lymphocytes

h.         CD19 + B Lymphocytes

i.          IL6

j.          Gut Microbiota Assessment

k.         Serum Neurofilament Light Chain

l.          Fetuin A

m.        Kurtzke Expanded Disability Scale

Background of the study:

Multiple sclerosis is a chronic autoimmune disease of the central nervous system (CNS) in which inflammation, demyelination, and axonal loss occurs in even early stages of the disease. Multiple sclerosis is a chronic, predominantly immune-mediated disease of the central nervous system, and one of the most common causes of neurological disability in young adults globally. The disease course can be extremely variable across individual patients, and although significant treatment advances have been made in recent years multiple sclerosis remains one of the most frequent causes of neurological disability in young people.

Purpose of the Study

The study product is a biological response modifier beta glucan produced by N-163 strain of Aureobasidium pullulans, black yeast. It is an effective immunomodulator.

In pre-clinical studies, it has been proven to have potent anti-inflammatory and anti-fibrotic properties which is useful in conditions that involve a dysregulated metabolism and fibrosis such as Fatty liver disease or non-alcoholic steatohepatitis, liver cirrhosis etc..

N - 163 Beta Glucan has potent anti-inflammatory activities which has been proven in animal and human clinical studies. In an animal study of obese diabetic mice model of KK-Ay mice, N - 163 Beta Glucan was able to regulate the levels of non-esterified fatty acids (NEFA) in 28 days. (7) NEFA is associated with metabolic syndrome induced inflammation. (8) And altered NEFA composition in immune cell membranes has been shown to influence immune cell functions possibly contributing to the positive correlations between these fatty acids and MS disease outcome. (9) In a clinical trial performed on patients with Duchenne muscular dystrophy (DMD), N - 163 Beta Glucan was able to decrease the levels of inflammatory markers, IL-6, TGF-β apart from increasing dystrophin levels and improving muscle strength in 45 days.