Vancomycin Study in Multiple Sclerosis (MS)

NCT ID: NCT05539729

Last Updated: 2025-09-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-31
• Study Completion Date: 2026-09-30

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.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Vancomycin

125mg antibiotic taken 4 times daily by mouth

Group Type: EXPERIMENTAL

Vancomycin

Intervention Type: 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.

Placebo

Matching placebo taken 4 times daily by mouth

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo created by the IDS and encapsulated in red coating to match the Study Drug.

Interventions

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.

Intervention Type: DRUG

Placebo

Placebo created by the IDS and encapsulated in red coating to match the Study Drug.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Doris Duke Charitable Foundation

OTHER

Sponsor Role: collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Stephanie K Tankou

Assistant Professor, Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stephanie K Tankou, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine

Locations

Corinne Goldsmith Dickinson Center for Multiple Sclerosis at Mount Sinai

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Susan E Filomena, BA

Role: CONTACT

susan.filomena@mssm.edu

212-2413841

Gena Persad

Role: CONTACT

gena.persad@mssm.edu

212-241-6604

Facility Contacts

Susan E Filomena, BA

Role: primary

susan.filomena@mssm.edu

212-241-3841

Abigail Hintermeister, MPA

Role: backup

abigail.hintermeister@mssm.edu

212-241-3391

Other Identifiers

GCO-22-0462

Identifier Type: -

Identifier Source: org_study_id