Vancomycin Study in Multiple Sclerosis (MS)
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
| Condition(s) | Multiple Sclerosis |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| 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. |
| Who can participate | 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 bow |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Lead sponsor | Icahn School of Medicine at Mount Sinai |
| Locations | New York, New York, United States |
| Start date | 2023-01-31 |
| NCT ID | NCT05539729 |
| Official listing | https://clinicaltrials.gov/study/NCT05539729 |