Clinical Study on Beta Glucan N 163 to treat Multiple Sclerosis
- Conditions
- Multiple sclerosis,
- Registration Number
- CTRI/2022/05/042497
- Lead Sponsor
- NichiIn Bio Sciences Pvt Ltd
- Brief Summary
**Study Design :** Open Label, Prospective, Non-Randomised, Non-Comparative Single ArmClinical Study
**Indication :** Multiple Sclerosis
**InvestigationalProduct :** N163 Beta Glucan
**Comparator:** None.
**Dose :** 1 sachet of Beta GlucanN-163 to be consumed with water 30 minutes after meal; once in the morning andonce in evening
**Dosage :** Two Sachets per day for 60 days
**SubjectPopulation** : Adults aged ≥21 years of age, allgenders inclusive; with diagnosis/historyof MS.
**Number of Subjects:** 20 Evaluable Subjects
**Treatment Arms:** One. Single Arm
**TreatmentDuration :** 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 ofthe study:**
Multiple sclerosisis a chronic autoimmune disease of the central nervous system (CNS) in whichinflammation, demyelination, and axonal loss occurs in even early stages of thedisease. Multiple sclerosis is a chronic, predominantly immune-mediated diseaseof the central nervous system, and one of the most common causes ofneurological disability in young adults globally. The disease course can beextremely variable across individual patients, and although significanttreatment advances have been made in recent years multiple sclerosis remainsone of the most frequent causes of neurological disability in young people.
**Purpose of the Study**
The study product is a biological response modifier beta glucanproduced by N-163 strain of Aureobasidium pullulans, black yeast. It is aneffective immunomodulator.
In pre-clinical studies, it has been proven to have potentanti-inflammatory and anti-fibrotic properties which is useful in conditionsthat involve a dysregulated metabolism and fibrosis such as Fatty liver diseaseor non-alcoholic steatohepatitis, liver cirrhosis etc..
N - 163 Beta Glucan has potent anti-inflammatory activities whichhas been proven in animal and human clinical studies. In an animal study ofobese diabetic mice model of KK-Ay mice, N - 163 Beta Glucan was able toregulate the levels of non-esterified fatty acids (NEFA) in 28 days. (7) NEFAis associated with metabolic syndrome induced inflammation. (8) And alteredNEFA composition in immune cell membranes has been shown to influence immunecell functions possibly contributing to the positive correlations between thesefatty acids and MS disease outcome. (9) In a clinical trial performed onpatients with Duchenne muscular dystrophy (DMD), N - 163 Beta Glucan was ableto decrease the levels of inflammatory markers, IL-6, TGF-β apart fromincreasing dystrophin levels and improving muscle strength in 45 days.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 20
- 1.Adults aged ≥21 years of age, all genders inclusive; with diagnosis/history of MS.
- 2.Subjects who have been on the same treatment regimen for a minimum of three months prior to enrolment and are willing to not make major changes to their standard treatment regimen until the end of the treatment period.
- 3.Subject/LAR who is willing to give written informed consent for participation, able to comprehend and understand the responsibilities during treatment period.
- 4.Subjects who are willing not to participate in any other clinical trial during participation in the current trial.
- 1.Subjects with history that suggests possible allergic reaction to the key constituents of the investigational product.
- 2.Subjects who have difficulty in swallowing or any condition that makes per oral medication difficult or impossible 3.Subjects who have undergone major surgical procedure 4 weeks prior to randomisation.
- 4.Subjects who are on anti-depressants, anti-psychotics or presenting in psychiatric condition that would interfere with the parameters of the clinical study.
- 5.Subjects with CKD or other diseases that impair normal kidney function.
- 6.Subjects with known history of clinically significant endocrine, gastrointestinal,cardiovascular,hematological,hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases; except those that are considered etiology or co-morbid to the study indication.
- 7.Females who are pregnant or lactating or planning to become pregnant during the study period.
- 8.Subjects who are currently participating or have participated in a clinical trial upto 90 days prior to randomisation 9.Subjects, who in the opinion of the investigator are unsuitable for enrolment.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 2.ESR : Improvement of ≥10% from baseline Day 1, Day 60 3.CD56 : Improvement of ≥10% from baseline Day 1, Day 60 1.CRP : Improvement of ≥10% from baseline Day 1, Day 60 4.CD16 + Immune Cells : : Improvement of ≥10% from baseline Day 1, Day 60 6.CD8 : Improvement of ≥10% from baseline Day 1, Day 60 5. CD4: Improvement of ≥10% from baseline Day 1, Day 60 7.CD3+ T Lymphocytes: Improvement of ≥10% from baseline Day 1, Day 60 8.CD19 +B Lymphocytes : Improvement of ≥10% from baseline Day 1, Day 60 9.IL6 : Improvement of ≥10% from baseline Day 1, Day 60 10.Gut Microbiota Metagenome Sequencing : Improvement from baseline in the stool sample analysis. Day 1, Day 60
- Secondary Outcome Measures
Name Time Method 1.Neurofilament Light Chain (NFL) : Improvement of ≥10% in sNfl from baseline 2.Fetuin A : : Improvement ≥10% from baseline
Trial Locations
- Locations (1)
Be Well Hospitals Private Limited
🇮🇳Chennai, TAMIL NADU, India
Be Well Hospitals Private Limited🇮🇳Chennai, TAMIL NADU, IndiaDr CJ VetrivelPrincipal investigator9841108873drvetri@bewellhospitals.com