NCT05539729

Vancomycin Study in Multiple Sclerosis (MS)

Impact of Vancomycin on the Gut Microbiome and Immune Function in Multiple Sclerosis

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	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.
DRUG	Placebo	Placebo created by the IDS and encapsulated in red coating to match the Study Drug.

Timeline

• Start date: 2023-01-31
• Primary completion: 2026-03-01
• Completion: 2026-09-01
• First posted: 2022-09-14
• Last updated: 2025-09-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study