Vancomycin for Multiple Sclerosis

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Corinne Goldsmith Dickinson Center for Multiple Sclerosis at Mount Sinai, New York, NY
Multiple Sclerosis+1 More
Vancomycin - Drug
Eligibility
18 - 65
All Sexes
What conditions do you have?
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Study 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.

Eligible Conditions

  • Multiple Sclerosis

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 14 Secondary · Reporting Duration: Baseline and 12 months

Baseline and 12 months
Change in number of gadolium enhancing brain lesions
Change in number of new brain lesions
Change in number of total brain lesions
Change in serum SCFAs levels
Change in stool SCFAs levels
Change in volume of gadolium enhancing brain lesions
Change in volume of new brain lesions
Change in volume of total brain lesions
Changes in abundance of short chain fatty acids (SCFAs)-producing bacteria
Changes in cortical brain volumes
Changes in number of paramagnetic rim lesions
Changes in thalamic brain volumes
Changes in total brain volumes
Changes in volume of paramagnetic rim lesions
Week 6
Changes in Serum Butyrate levels
Changes in abundance of butyrate producing bacteria
Changes in number of peripheral T cells

Trial Safety

Trial Design

2 Treatment Groups

Vancomycin
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group

40 Total Participants · 2 Treatment Groups

Primary Treatment: Vancomycin · Has Placebo Group · Phase 1

Vancomycin
Drug
Experimental Group · 1 Intervention: Vancomycin · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vancomycin
2005
Completed Phase 4
~7930

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline and 12 months

Trial Background

Prof. Stephanie K Tankou, Assistant Professor, Neurology
Principal Investigator
Icahn School of Medicine at Mount Sinai
Closest Location: Corinne Goldsmith Dickinson Center for Multiple Sclerosis at Mount Sinai · New York, NY
Photo of New York  1Photo of New York  2Photo of New York  3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Multiple Sclerosis
0 CompletedClinical Trials

Eligibility Criteria

Age 18 - 65 · All Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are aged 18 - 45.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.