多发性硬化症 (MS) 中的万古霉素研究
万古霉素对多发性硬化症患者肠道微生物组和免疫功能的影响
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.
研究概览
研究类型
注册 (估计的)
阶段
- 阶段1
联系人和位置
学习联系方式
- 姓名：Susan E Filomena, BA
- 电话号码：212-2413841
- 邮箱：susan.filomena@mssm.edu
研究联系人备份
- 姓名：Gena Persad
- 电话号码：212-241-6604
- 邮箱：gena.persad@mssm.edu
学习地点
-
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New York
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New York、New York、美国、10029
- 招聘中
- Corinne Goldsmith Dickinson Center for Multiple Sclerosis at Mount Sinai
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接触：
- Susan E Filomena, BA
- 电话号码：212-241-3841
- 邮箱：susan.filomena@mssm.edu
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接触：
- Abigail Hintermeister, MPA
- 电话号码：212-241-3391
- 邮箱：abigail.hintermeister@mssm.edu
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首席研究员：
- Stephanie K Tankou
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Vancomycin
125mg antibiotic taken 4 times daily by mouth |
A marketed antibiotic (Study Drug) supplied by Amerisource Bergen, by the Mount Sinai Investigational Drug Services (IDS), and encapsulated in red coating to match the placebo. |
|
安慰剂比较：Placebo
Matching placebo taken 4 times daily by mouth |
Placebo created by the IDS and encapsulated in red coating to match the Study Drug. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Changes in abundance of butyrate producing bacteria
大体时间：Baseline up to 6 weeks
|
Changes in abundance of butyrate producing bacteria from baseline treatment up to 6 weeks |
Baseline up to 6 weeks
|
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Changes in Serum Butyrate levels
大体时间：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. |
Baseline up to 6 weeks
|
|
Changes in number of peripheral T cells
大体时间：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. |
Baseline up to 6 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
钆增强脑损伤体积的变化
大体时间：基线和 12 个月
|
基线和 12 个月
|
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新脑损伤数量的变化
大体时间：基线和 12 个月
|
基线和 12 个月
|
|
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新脑损伤体积的变化
大体时间：基线和 12 个月
|
基线和 12 个月
|
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总脑损伤数量的变化
大体时间：基线和 12 个月
|
基线和 12 个月
|
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总脑损伤体积的变化
大体时间：基线和 12 个月
|
基线和 12 个月
|
|
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Changes in abundance of short chain fatty acids (SCFAs)-producing bacteria
大体时间：Baseline and 12 months
|
Changes in abundance of SCFA-producing bacteria |
Baseline and 12 months
|
|
Change in stool SCFAs levels
大体时间：Baseline and 12 months
|
Change in stool SCFAs levels SCFAs are substance that are produce when gut bacteria breaks down food. |
Baseline and 12 months
|
|
Change in serum SCFAs levels
大体时间：Baseline and 12 months
|
Change in serum SCFAs levels |
Baseline and 12 months
|
|
Change in number of gadolium enhancing brain lesions
大体时间：Baseline and 12 months
|
Change in number gadolium enhancing brain lesions A lesion is a brain injury caused by inflammation. Gadolinium is a dye that is used to visualize areas of active inflammation in the brain. |
Baseline and 12 months
|
|
Changes in number of paramagnetic rim lesions
大体时间：Baseline and 12 months
|
Changes in number of paramagnetic rim lesions Paramagnetic rim lesions are a type of brain injury found in MS patients. |
Baseline and 12 months
|
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Changes in volume of paramagnetic rim lesions
大体时间：Baseline and 12 months
|
Changes in volume of paramagnetic rim lesions |
Baseline and 12 months
|
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Changes in thalamic brain volumes
大体时间：Baseline and 12 months
|
Changes in thalamic brain volumes |
Baseline and 12 months
|
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Changes in cortical brain volumes
大体时间：Baseline and 12 months
|
Changes in cortical brain volumes |
Baseline and 12 months
|
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Changes in total brain volumes
大体时间：Baseline and 12 months
|
Changes in total brain volumes |
Baseline and 12 months
|
合作者和调查者
调查人员
- 首席研究员：Stephanie K Tankou, MD、Icahn School of Medicine
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- GCO-22-0462
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
The investigator is not developing the product. The study has been exempted from an IND by the FDA, since it entails the off-label use of a marketed drug.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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