Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Doris Duke Charitable Foundation | OTHER |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vancomycin | Experimental | 125mg antibiotic taken 4 times daily by mouth |
|
| Placebo | Placebo Comparator | Matching placebo taken 4 times daily by mouth |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vancomycin | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in abundance of butyrate producing bacteria | Changes in abundance of butyrate producing bacteria from baseline treatment up to 6 weeks | 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. | 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. | Baseline up to 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in abundance of short chain fatty acids (SCFAs)-producing bacteria | Changes in abundance of SCFA-producing bacteria | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Susan E Filomena, BA | Contact | 212-2413841 | susan.filomena@mssm.edu | |
| Gena Persad | Contact | 212-241-6604 | gena.persad@mssm.edu |
| Name | Affiliation | Role |
|---|---|---|
| Stephanie K Tankou, MD | Icahn School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Corinne Goldsmith Dickinson Center for Multiple Sclerosis at Mount Sinai | Recruiting | New York | New York | 10029 | United States |
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D000090862 | Neuroinflammatory Diseases |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D014640 | Vancomycin |
| ID | Term |
|---|---|
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
Not provided
Not provided
Placebo-controlled blinded trial
Not provided
Not provided
The research team will be blinded to the treatment group (placebo/vancomycin).
| Placebo | Drug | Placebo created by the IDS and encapsulated in red coating to match the Study Drug. |
|
| Baseline and 12 months |
| Change in serum SCFAs levels | Change in serum SCFAs levels | 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. | Baseline and 12 months |
| Change in volume of gadolium enhancing brain lesions | Baseline and 12 months |
| Change in number of new brain lesions | Baseline and 12 months |
| Change in volume of new brain lesions | Baseline and 12 months |
| Change in number of total brain lesions | Baseline and 12 months |
| Change in volume of total brain lesions | 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. | Baseline and 12 months |
| Changes in volume of paramagnetic rim lesions | Changes in volume of paramagnetic rim lesions | Baseline and 12 months |
| Changes in thalamic brain volumes | Changes in thalamic brain volumes | Baseline and 12 months |
| Changes in cortical brain volumes | Changes in cortical brain volumes | Baseline and 12 months |
| Changes in total brain volumes | Changes in total brain volumes | Baseline and 12 months |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000602 |
| Amino Acids, Peptides, and Proteins |