What side effects are associated with this type of intervention?

Common treatments for Multiple Sclerosis (MS) include disease-modifying therapies (DMTs) such as interferon beta, glatiramer acetate, and dimethyl fumarate. These treatments can have side effects such as flu-like symptoms, injection site reactions, and gastrointestinal issues. Specifically, vancomycin, an antibiotic that alters gut microbiota composition, is being studied for its potential effects on MS. While vancomycin can disrupt gut microbiota, its side effects may include gastrointestinal disturbances, potential nephrotoxicity, and ototoxicity. It is important for patients to discuss these potential side effects with their healthcare provider to make an informed decision.

What prior FDA approvals exist?

The FDA has approved several disease-modifying therapies for Multiple Sclerosis (MS), including oral formulations like dimethyl fumarate (BG-12) and injectable treatments such as glatiramer acetate. These treatments primarily aim to reduce relapse rates and slow the progression of disability. While the trial on vancomycin is investigating its effects on the gut microbiota and its potential role in modulating neuroinflammation in MS, there are no specific FDA-approved MS treatments that focus on altering gut microbiota composition. Current approved therapies focus on immunomodulation and reducing inflammatory activity in the central nervous system.

What other types of research exist?

Promising novel alternatives to Vancomycin for Multiple Sclerosis patients include Diroximel Fumarate, Dimethyl Fumarate, and Teriflunomide. These disease-modifying therapies have shown efficacy in treating MS and may also impact gut microbiota.

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Antibiotic

Vancomycin for Multiple Sclerosis

Q: What is the mechanism of action of this treatment?

Multiple Sclerosis (MS) treatments often target the immune system to reduce neuroinflammation and slow disease progression. Vancomycin, an antibiotic, is being studied for its potential to alter the gut microbiota, which may influence the gut-brain axis and modulate immune responses in MS patients. This is significant because the gut microbiome plays a crucial role in autoimmunity, and altering its composition could potentially reduce neuroinflammation. Other common treatments include disease-modifying therapies like interferons and glatiramer acetate, which work by modulating the immune system to prevent immune cells from attacking the myelin sheath. Understanding these mechanisms is vital for MS patients as it helps in selecting appropriate therapies that can effectively manage symptoms and improve quality of life.

Phase 1

Recruiting

Led By Stephanie K Tankou, MD

Research Sponsored by Icahn School of Medicine at Mount Sinai

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 12 months

Summary

This trial is testing vancomycin, an antibiotic, to see if it can change gut bacteria and help reduce brain inflammation in people with multiple sclerosis (MS). The goal is to understand if altering gut bacteria can improve immune function and lessen MS symptoms.

Who is the study for?

This trial is for adults aged 18-50 with newly diagnosed Multiple Sclerosis (MS) who haven't received treatment yet. Participants must understand the study and consent to join. Exclusions include recent gastroenteritis, chronic infections like hepatitis or HIV, antibiotic use in the last 90 days, pregnancy/postpartum women, bowel issues/surgery history, recent travel abroad, certain medication uses including immunosuppressants and steroids.

What is being tested?

The study aims to see how vancomycin affects gut bacteria and MS by comparing it with a placebo. Researchers will look at changes in gut microbiota composition, immune function outside of the brain, and MRI scans of the brain to track any effects on neuroinflammation.

What are the potential side effects?

Potential side effects from vancomycin may include kidney problems due to reduced filtration rate (less than <60ml/min), hearing impairment or allergic reactions. The exact side effects related to MS symptoms are not specified but could be monitored through MRI lesions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Body Weight Changes

Changes in abundance of butyrate producing bacteria

Changes in number of peripheral T cells

Secondary study objectives

Brain

Change in serum SCFAs levels

Change in stool SCFAs levels

+6 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: VancomycinExperimental Treatment1 Intervention

125mg antibiotic taken 4 times daily by mouth

Group II: PlaceboPlacebo Group1 Intervention

Matching placebo taken 4 times daily by mouth

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Vancomycin

2020

Completed Phase 4

~7920

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Multiple Sclerosis (MS) treatments often target the immune system to reduce neuroinflammation and slow disease progression. Vancomycin, an antibiotic, is being studied for its potential to alter the gut microbiota, which may influence the gut-brain axis and modulate immune responses in MS patients. This is significant because the gut microbiome plays a crucial role in autoimmunity, and altering its composition could potentially reduce neuroinflammation. Other common treatments include disease-modifying therapies like interferons and glatiramer acetate, which work by modulating the immune system to prevent immune cells from attacking the myelin sheath. Understanding these mechanisms is vital for MS patients as it helps in selecting appropriate therapies that can effectively manage symptoms and improve quality of life.