Impact of Vancomycin on the Gut Microbiome and Immune Function in Multiple Sclerosis
Icahn School of Medicine at Mount Sinai
Summary
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.
Eligibility
- Age range
- 18–50 years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugVancomycin
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.
- DrugPlacebo
Placebo created by the IDS and encapsulated in red coating to match the Study Drug.
Location
- Corinne Goldsmith Dickinson Center for Multiple Sclerosis at Mount SinaiNew York, New York