Effects of Probiotics on Inflammatory Biomarkers in Persons With Multiple Sclerosis (MS) and in Family Members of Persons With MS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 2
- 主要终点
- peripheral blood mononuclear cell (PBMC) profile: Change in T helper Th17 cells
研究概览
简要总结
The goal of this study is to assess the effects of probiotics on persons with multiple sclerosis (MS), persons at higher genetic risk for MS (first degree family members of persons with MS), and healthy controls. Participants will be asked to consume probiotic containing chocolates (Bouchard Belgian Dark Chocolate Probiotic Napolitains containing 10 billion CFUs of bifidobacterium longum per day) for 6 weeks. Participants will undergo blood draws before and after the 6 weeks of probiotic containing chocolate and microbial metabolites and immune markers will be compared before and after the probiotics, as well as between groups.
详细描述
The goal of this study is to assess the effects of probiotics in persons with MS (PwMS), persons at high genetic risk for MS (first degree family members of PwMS), and healthy controls. PwMS. Subjects undergo blood draws and will complete surveys on neurological symptoms (as relevant). Subjects are given a supply of individually wrapped probiotic containing chocolates (Bouchard Belgian Dark Chocolate Probiotic Napolitains) along with instructions on proper storage, dosage, and a diary to complete regarding supplement adherence. After a "ramp up" period of 3 days during which participants will consume take 2 chocolates per day, participants consume 5 chocolates per day (10 billion CFUs of bifidobacterium longum per day) for 6 weeks. After 6 weeks participants return the adherence diaries and answer questions about probiotic tolerance. They also repeat similar surveys and again undergo blood draws. Serum levels of microbial metabolites and peripheral blood immune profiles are assessed before and after supplementation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Multiple Sclerosis (MS) subjects, first-degree relatives of MS subjects, or healthy controls
- •Age 18-45
排除标准
- •tree nut allergy
- •pregnancy
结局指标
主要结局
peripheral blood mononuclear cell (PBMC) profile: Change in T helper Th17 cells
时间窗: baseline (week 0) to week 6
percent change in Th17 cells from baseline to week 6
peripheral blood mononuclear cell (PBMC) profile: Change in Regulatory T (Treg) cells
时间窗: baseline (week 0) to week 6
percent change in Treg cells from baseline to week 6
Change in serum microbial metabolites
时间窗: baseilne (week 0) to week 6
percent change in short chain fatty acid levels from baseline to week 6
peripheral blood mononuclear cell (PBMC) profile: Change in T helper (TH) cells
时间窗: baseline (week 0) to week 6
change in ratio of TH1 to Th2 cells from baseline to week 6
次要结局
- Change in Patient-Determined Disability Scale (PDDS)(week 0, week 6)
- Change in Bowel Control Scale(week 0, week 6)
- Change in Modified Fatigue Impact Scale-5 Impact Scale(week 0, week 6)
- Change in Multiple Sclerosis Rating Scale- Revised (MSRS-R) Patient-Determined Disease Steps Scale(week 0, week 6)