RecruitingPhase 1NCT05539729

Vancomycin Study in Multiple Sclerosis (MS)

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


Sponsor

Icahn School of Medicine at Mount Sinai

Enrollment

12 participants

Start Date

Jan 31, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether vancomycin — an antibiotic — can alter the gut microbiome (the trillions of bacteria living in your intestines) and potentially affect the course of multiple sclerosis (MS). There is growing evidence that gut bacteria play a role in immune system regulation, and this study explores whether disrupting certain bacteria early in MS could influence disease activity. **You may be eligible if:** - You are 18–50 years old - You have been newly diagnosed with MS, clinically isolated syndrome (CIS), or radiologically isolated syndrome (RIS) within the past year - You have not yet started any MS treatment - You are able to understand the risks and give informed consent **You may NOT be eligible if:** - You have taken antibiotics in the past 90 days - You have taken probiotics, prebiotics, or corticosteroids in the past month - You currently smoke - You have a history of inflammatory bowel disease, chronic infections (hepatitis B/C, HIV), or serious gut conditions - You are pregnant or less than 6 months postpartum Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGVancomycin

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.

DRUGPlacebo

Placebo created by the IDS and encapsulated in red coating to match the Study Drug.


Locations(1)

Corinne Goldsmith Dickinson Center for Multiple Sclerosis at Mount Sinai

New York, New York, United States

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NCT05539729


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