Vancomycin for Multiple Sclerosis
Phase-Based Progress Estimates
Effectiveness
Safety
Corinne Goldsmith Dickinson Center for Multiple Sclerosis at Mount Sinai, New York, NY
Multiple Sclerosis+1 More
Vancomycin - DrugEligibility
18 - 65
All Sexes
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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
Other trials for Multiple Sclerosis
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
Safety Progress
Other trials for Multiple Sclerosis
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: DrugPlacebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: DrugTreatment
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
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 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.
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