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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
12
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.
Placebo created by the IDS and encapsulated in red coating to match the Study Drug.
Corinne Goldsmith Dickinson Center for Multiple Sclerosis at Mount Sinai
New York, New York, United States
RECRUITINGChanges in abundance of butyrate producing bacteria
Changes in abundance of butyrate producing bacteria from baseline treatment up to 6 weeks
Time frame: Baseline up to 6 weeks
Changes in Serum Butyrate levels
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.
Time frame: Baseline up to 6 weeks
Changes in number of peripheral T cells
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.
Time frame: Baseline up to 6 weeks
Changes in abundance of short chain fatty acids (SCFAs)-producing bacteria
Changes in abundance of SCFA-producing bacteria
Time frame: Baseline and 12 months
Change in stool SCFAs levels
Change in stool SCFAs levels SCFAs are substance that are produce when gut bacteria breaks down food.
Time frame: Baseline and 12 months
Change in serum SCFAs levels
Change in serum SCFAs levels
Time frame: Baseline and 12 months
Change in number of gadolium enhancing brain lesions
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.
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Time frame: Baseline and 12 months
Change in volume of gadolium enhancing brain lesions
Time frame: Baseline and 12 months
Change in number of new brain lesions
Time frame: Baseline and 12 months
Change in volume of new brain lesions
Time frame: Baseline and 12 months
Change in number of total brain lesions
Time frame: Baseline and 12 months
Change in volume of total brain lesions
Time frame: Baseline and 12 months
Changes in number of paramagnetic rim lesions
Changes in number of paramagnetic rim lesions Paramagnetic rim lesions are a type of brain injury found in MS patients.
Time frame: Baseline and 12 months
Changes in volume of paramagnetic rim lesions
Changes in volume of paramagnetic rim lesions
Time frame: Baseline and 12 months
Changes in thalamic brain volumes
Changes in thalamic brain volumes
Time frame: Baseline and 12 months
Changes in cortical brain volumes
Changes in cortical brain volumes
Time frame: Baseline and 12 months
Changes in total brain volumes
Changes in total brain volumes
Time frame: Baseline and 12 months