Vancomycin Study in Multiple Sclerosis (MS)

Phase 1

Recruiting

• Conditions: Multiple Sclerosis
• Interventions: Drug: Vancomycin; Drug: Placebo

• Registration Number: NCT05539729
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-12
• Study First Submitted QC: 2022-09-12
• Study First Posted: 2022-09-14
• Study Start: 2023-01-31
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-18
• Last Update Posted: 2025-04-23
• Primary Completion: 2026-03
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 12

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 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 major 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vancomycin	Vancomycin	125mg antibiotic taken 4 times daily by mouth
Placebo	Placebo	Matching placebo taken 4 times daily by mouth

Primary Outcome Measures

Name	Time	Method
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 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.
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.

Secondary Outcome Measures

Name	Time	Method
Change in volume of gadolium enhancing brain lesions	Baseline and 12 months
Change in volume of new 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 thalamic brain volumes	Baseline and 12 months	Changes in thalamic brain volumes
Changes in total brain volumes	Baseline and 12 months	Changes in total brain volumes
Changes in abundance of short chain fatty acids (SCFAs)-producing bacteria	Baseline and 12 months	Changes in abundance of SCFA-producing bacteria
Changes in cortical brain volumes	Baseline and 12 months	Changes in cortical brain volumes
Change in number of total brain lesions	Baseline and 12 months
Change in volume of total brain lesions	Baseline and 12 months
Changes in volume of paramagnetic rim lesions	Baseline and 12 months	Changes in volume of paramagnetic rim lesions
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 number of new brain lesions	Baseline and 12 months

Trial Locations

Locations (1)

Corinne Goldsmith Dickinson Center for Multiple Sclerosis at Mount Sinai; 🇺🇸 New York, New York, United States