Vancomycin Study in Multiple Sclerosis (MS)

Part of paid clinical trials in New York, New York.

Sponsor
Icahn School of Medicine at Mount Sinai
Study ID
NCT05539729
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • Vancomycin — 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 — DRUG
    Placebo created by the IDS and encapsulated in red coating to match the Study Drug.

Study Details

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.

Key Dates

Start date
Jan 31, 2023
Status verified
Apr 2025
Primary completion
Mar 31, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
12 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Vancomycin
    125mg antibiotic taken 4 times daily by mouth
  • Placebo Comparator: Placebo
    Matching placebo taken 4 times daily by mouth

Primary Outcome Measure

Changes in abundance of butyrate producing bacteria [ Time Frame: Baseline up to 6 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Corinne Goldsmith Dickinson Center for Multiple Sclerosis at Mount SinaiNew YorkNew York10029
Susan E Filomena, BA
[email protected]
212-241-3841
Abigail Hintermeister, MPA
[email protected]
212-241-3391
Stephanie K Tankou (PRINCIPAL_INVESTIGATOR)

Find similar trials in New York, NY

By condition
Multiple sclerosis
By specialty
NeurologyBrain disordersAutoimmune disease
By research site
Corinne Goldsmith Dickinson Center for Multiple Sclerosis at Mount Sinai· New York, NY

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