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Antibiotic

Vancomycin for Multiple Sclerosis

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
Treatment naive
Able to understand the risks, benefits, and alternatives of participation and give meaningful consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 12 months
Awards & highlights

Study Summary

This trial will investigate whether vancomycin can help treat MS by altering the gut microbiome and reducing neuroinflammation.

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.Check my eligibility
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.See study design
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have not received any treatment for my condition.
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I understand the risks and benefits of the trial and can consent.
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I am between 18 and 50 years old.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Body Weight Changes
Changes in abundance of butyrate producing bacteria
Changes in number of peripheral T cells
Secondary outcome measures
Brain
Change in number of new brain lesions
Change in number of total brain lesions
+11 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
2005
Completed Phase 4
~7930

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor
854 Previous Clinical Trials
535,978 Total Patients Enrolled
8 Trials studying Multiple Sclerosis
503 Patients Enrolled for Multiple Sclerosis
Doris Duke Charitable FoundationOTHER
60 Previous Clinical Trials
260,098 Total Patients Enrolled
Stephanie K Tankou, MDPrincipal InvestigatorIcahn School of Medicine

Media Library

Vancomycin (Antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT05539729 — Phase 1
Multiple Sclerosis Research Study Groups: Placebo, Vancomycin
Multiple Sclerosis Clinical Trial 2023: Vancomycin Highlights & Side Effects. Trial Name: NCT05539729 — Phase 1
Vancomycin (Antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05539729 — Phase 1
Multiple Sclerosis Patient Testimony for trial: Trial Name: NCT05539729 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible for senior citizens to become part of this investigation?

"The age requirement for this clinical trial mandates that all candidates must be over 18 years of age and below 45."

Answered by AI

What has been the verdict from the Food and Drug Administration concerning Vancomycin?

"There is only a smattering of data attesting to vancomycin's safety, so it earned the lowest score possible on our scale (1)."

Answered by AI

Are there still opportunities for patients to join this research experiment?

"Affirmative, according to information provided on clinicaltrials.gov this research is currently recruiting participants. The trial was first publicized on November 8th 2022 and has since been updated on the 21st of that same month. 40 patients are required for a single medical centre."

Answered by AI

Are there any qualifying criteria for participating in this medical research?

"This medical study is seeking 40 individuals aged 18-45 who have recently been diagnosed (within 6 months) with multiple sclerosis, and are yet to receive treatment. These patients must also be intending to use a disease modifying therapy for their MS."

Answered by AI

What is the estimated number of participants in this research initiative?

"Affirmative. The information on clinicaltrials.gov reveals that this medical study, which was first published on November 8th 2022, is currently recruiting participants. 40 individuals are being sought at a single trial site."

Answered by AI

Who else is applying?

What state do they live in?
New York
What site did they apply to?
Corinne Goldsmith Dickinson Center for Multiple Sclerosis at Mount Sinai
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
3+

Why did patients apply to this trial?

I have cannot walk without a walker and am fall very easily.
PatientReceived 2+ prior treatments
~8 spots leftby Dec 2026