Vancomycin Study in Multiple Sclerosis (MS)
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Vancomycin 125mg antibiotic taken 4 times daily by mouth |
Drug: Vancomycin
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 Comparator: Placebo Matching placebo taken 4 times daily by mouth |
Drug: Placebo
Placebo created by the IDS and encapsulated in red coating to match the Study Drug.
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Outcome Measures
Primary Outcome Measures
- Changes in abundance of butyrate producing bacteria [Baseline up to 6 weeks]
Changes in abundance of butyrate producing bacteria from baseline treatment up to 6 weeks
- Changes in Serum Butyrate levels [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.
- Changes in number of peripheral T cells [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.
Secondary Outcome Measures
- Changes in abundance of short chain fatty acids (SCFAs)-producing bacteria [Baseline and 12 months]
Changes in abundance of SCFA-producing bacteria
- Change in stool SCFAs levels [Baseline and 12 months]
Change in stool SCFAs levels SCFAs are substance that are produce when gut bacteria breaks down food.
- Change in serum SCFAs levels [Baseline and 12 months]
Change in serum SCFAs levels
- Change in number of gadolium enhancing brain lesions [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.
- 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 [Baseline and 12 months]
Changes in number of paramagnetic rim lesions Paramagnetic rim lesions are a type of brain injury found in MS patients.
- Changes in volume of paramagnetic rim lesions [Baseline and 12 months]
Changes in volume of paramagnetic rim lesions
- Changes in thalamic brain volumes [Baseline and 12 months]
Changes in thalamic brain volumes
- Changes in cortical brain volumes [Baseline and 12 months]
Changes in cortical brain volumes
- Changes in total brain volumes [Baseline and 12 months]
Changes in total brain volumes
Eligibility Criteria
Criteria
Inclusion Criteria:
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Newly diagnosed ((symptoms onset less than 6 months ago),
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treatment naive MS patients
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aged 18 - 45
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who intend to use a disease-modifying therapy to treat multiple sclerosis.
Exclusion Criteria:
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Antibiotic use within the past 90 days, pre- or probiotic use within past month or corticosteroids use within the past month;
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Use of tobacco products within the past 1 month;
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History of treatment with immunosuppressants;
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History of gastroenteritis within the past month or diagnosis with a chronic infectious disease, i.e. hepatitis B, C or HIV. Patients are screened clinically for hepatitis B and C, and HIV, before MS treatment selection;
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Pregnancy or less than 6 months postpartum;
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Irritable bowel syndrome and other bowel dysfunction such as constipation; or history of bowel surgery;
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Inflammatory bowel disease, rheumatoid arthritis, systemic lupus erythematosus, diabetes and any other auto-immune illness;
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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 depression, schizophrenia and presence of psychotic symptoms);
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Eating disorders such as anorexia nervosa, bulimia, or binge eating syndrome;
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Travel outside of the country within the past month.
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Contraindication to vancomycin including estimated glomerular filtration rate of <60ml/min, impaired hearing or known allergy.
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Contraindication to MRI such as implanted metallic objects.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Corinne Goldsmith Dickinson Center for Multiple Sclerosis at Mount Sinai | New York | New York | United States | 10029 |
Sponsors and Collaborators
- Icahn School of Medicine at Mount Sinai
- Doris Duke Charitable Foundation
Investigators
- Principal Investigator: Stephanie K Tankou, MD, Icahn School of Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- GCO-22-0462