Vancomycin Study in Multiple Sclerosis (MS)

• Status: Not yet recruiting
• Trial end date: 2024-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborator: Doris Duke Charitable Foundation
• Treatments: Vancomycin

Criteria

Inclusion Criteria:

• Newly diagnosed ((symptoms onset less than 6 months ago),

• treatment naive MS patients

• aged 18 - 45

• who intend to use a disease-modifying therapy to treat multiple sclerosis.

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. Patients are screened clinically for hepatitis B and C, and HIV, before MS treatment selection;

• Pregnancy or less than 6 months postpartum;

• Irritable bowel syndrome and other bowel dysfunction such as constipation; or history of bowel surgery;

• Inflammatory bowel disease, rheumatoid arthritis, systemic lupus erythematosus, diabetes and any other auto-immune illness;

• 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);

• Eating disorders such as anorexia nervosa, bulimia, or binge eating syndrome;

• Travel outside of the country within the past month.

• Contraindication to vancomycin including estimated glomerular filtration rate of <60ml/min, impaired hearing or known allergy.

• Contraindication to MRI such as implanted metallic objects.