Impact of Vancomycin on the Gut Microbiome and Immune Function in Multiple Sclerosis
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Changes in abundance of butyrate producing bacteria
研究概览
简要总结
The overall goal of this study is to elucidate a mechanism by which vancomycin modulates the gut-brain axis in multiple sclerosis (MS). The gut microbiome plays an important role in autoimmunity, including MS. However, the identity of gut microbes modulating neuroinflammation in MS and their mechanisms of action remain obscure. Hence, here the research team proposes to investigate the effects of vancomycin on the gut microbiota composition, peripheral immune function, and brain MRI lesions in MS patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
The research team will be blinded to the treatment group (placebo/vancomycin).
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 18 - 50
- •newly diagnosed MS (2017 McDonald criteria), CIS or RIS patients, who have experienced symptoms no earlier than the past year
- •treatment naive
- •able to understand the risks, benefits, and alternatives of participation and give meaningful consent
排除标准
- •antibiotic use within the past 90 days;
- •pre- or probiotic use within past month or corticosteroids use within the past month;
- •use of tobacco products within the past 1 month;
- •history of treatment with immunosuppressants;
- •history of gastroenteritis within the past month or diagnosis with a chronic infectious disease, i.e. hepatitis B, C or HIV;
- •pregnancy or less than 6 months postpartum;
- •irritable bowel syndrome and other bowel dysfunction such as constipation;
- •history of bowel surgery;
- •inflammatory bowel disease, rheumatoid arthritis, systemic lupus erythematosus, diabetes and any other auto-immune illness;
- •diagnosis with another neurological disease, behavioral or psychiatric conditions that would be incompatible with a safe and successful participation in the study (such as severe major depression, schizophrenia and presence of psychotic symptoms);
- •eating disorders such as anorexia nervosa, bulimia, or binge eating syndrome;
- •travel outside of the country within the past month;
- •contraindication to vancomycin including estimated glomerular filtration rate of <60ml/min, impaired hearing or known allergy.
- •Contraindication to MRI such as implanted metallic objects
研究组 & 干预措施
Placebo
Matching placebo taken 4 times daily by mouth
干预措施: Placebo (Drug)
Vancomycin
125mg antibiotic taken 4 times daily by mouth
干预措施: Vancomycin (Drug)
结局指标
主要结局
Changes in abundance of butyrate producing bacteria
时间窗: Baseline up to 6 weeks
Changes in abundance of butyrate producing bacteria from baseline treatment up to 6 weeks
Changes in number of peripheral T cells
时间窗: Baseline up to 6 weeks
Change in frequency of peripheral regulatory T cells baseline treatment up to 6 weeks. T cells are a type of lymphocyte. Lymphocytes are a type of white blood cell. They make up part of the immune system. T cells help the body fight diseases or harmful substances, such as bacteria or viruses.
Changes in Serum Butyrate levels
时间窗: Baseline up to 6 weeks
Changes in serum butyrate level from baseline treatment up to 6 weeks Butyrate is a substance that is produce when gut bacteria breaks down food. Butyrate can get into our blood circulation and regulate how our immune cells function.
次要结局
- Changes in number of paramagnetic rim lesions(Baseline and 12 months)
- Changes in thalamic brain volumes(Baseline and 12 months)
- Change in volume of gadolium enhancing brain lesions(Baseline and 12 months)
- Change in volume of new brain lesions(Baseline and 12 months)
- Changes in total brain volumes(Baseline and 12 months)
- Changes in abundance of short chain fatty acids (SCFAs)-producing bacteria(Baseline and 12 months)
- Changes in cortical brain volumes(Baseline and 12 months)
- Change in number of total brain lesions(Baseline and 12 months)
- Change in stool SCFAs levels(Baseline and 12 months)
- Change in serum SCFAs levels(Baseline and 12 months)
- Change in number of gadolium enhancing brain lesions(Baseline and 12 months)
- Change in number of new brain lesions(Baseline and 12 months)
- Change in volume of total brain lesions(Baseline and 12 months)
- Changes in volume of paramagnetic rim lesions(Baseline and 12 months)
研究者
Stephanie K Tankou
Assistant Professor, Neurology
Icahn School of Medicine at Mount Sinai