An Open Label, Prospective, Non-Randomised, Non-Comparative Single Arm Clinical Study to Evaluate the Effects of N163 Strain of Aureobasidium Pullulans Produced β 1,3-16 Glucans (Beta Glucan) in modulating the immunity in patients with Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- 2.ESR : Improvement of ≥10% from baseline
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 21.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
2.ESR : Improvement of ≥10% from baseline
时间窗: Day 1, Day 60
3.CD56 : Improvement of ≥10% from baseline
时间窗: Day 1, Day 60
1.CRP : Improvement of ≥10% from baseline
时间窗: Day 1, Day 60
4.CD16 + Immune Cells : : Improvement of ≥10% from baseline
时间窗: Day 1, Day 60
6.CD8 : Improvement of ≥10% from baseline
时间窗: Day 1, Day 60
5. CD4: Improvement of ≥10% from baseline
时间窗: Day 1, Day 60
7.CD3+ T Lymphocytes: Improvement of ≥10% from baseline
时间窗: Day 1, Day 60
8.CD19 +B Lymphocytes : Improvement of ≥10% from baseline
时间窗: Day 1, Day 60
9.IL6 : Improvement of ≥10% from baseline
时间窗: Day 1, Day 60
10.Gut Microbiota Metagenome Sequencing : Improvement from baseline in the stool sample analysis.
时间窗: Day 1, Day 60
次要结局
- 1.Neurofilament Light Chain (NFL) : Improvement of ≥10% in sNfl from baseline(2.Fetuin A : : Improvement ≥10% from baseline)