Actively Recruiting

Phase 1
Age: 18Years - 50Years
All Genders
NCT05539729

Vancomycin Study in Multiple Sclerosis (MS)

Led by Icahn School of Medicine at Mount Sinai · Updated on 2025-09-10

12

Participants Needed

1

Research Sites

187 weeks

Total Duration

On this page

Sponsors

I

Icahn School of Medicine at Mount Sinai

Lead Sponsor

D

Doris Duke Charitable Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Vancomycin Study in Multiple Sclerosis (MS)

Who Can Participate

Age: 18Years - 50Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 to 50 years
  • Newly diagnosed with multiple sclerosis, clinically isolated syndrome, or radiologically isolated syndrome according to 2017 McDonald criteria
  • Symptoms started within the past year
  • Treatment naive (have not received prior treatments)
  • Able to understand study risks and provide informed consent
Not Eligible

You will not qualify if you...

  • Antibiotic use within the past 90 days
  • Use of prebiotics, probiotics, or corticosteroids within the past month
  • Use of tobacco products within the past month
  • History of treatment with immunosuppressants
  • History of gastroenteritis within the past month or chronic infectious diseases such as hepatitis B, C, or HIV
  • Pregnant or less than 6 months postpartum
  • Irritable bowel syndrome or other bowel dysfunctions like constipation
  • History of bowel surgery
  • Inflammatory bowel disease, rheumatoid arthritis, systemic lupus erythematosus, diabetes, or other autoimmune illnesses
  • Diagnosis of other neurological, behavioral, or psychiatric disorders incompatible with study participation
  • Eating disorders such as anorexia nervosa, bulimia, or binge eating syndrome
  • Travel outside the country within the past month
  • Contraindications to vancomycin including low kidney function, impaired hearing, or allergy
  • Contraindications to MRI such as implanted metallic objects

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Corinne Goldsmith Dickinson Center for Multiple Sclerosis at Mount Sinai

New York, New York, United States, 10029

Actively Recruiting

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Research Team

S

Susan E Filomena, BA

CONTACT

G

Gena Persad

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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