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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
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 12 months
Awards & highlights
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
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 moreTrial 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
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.
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Who is running the clinical trial?
Icahn School of Medicine at Mount SinaiLead Sponsor
893 Previous Clinical Trials
536,906 Total Patients Enrolled
8 Trials studying Multiple Sclerosis
503 Patients Enrolled for Multiple Sclerosis
Doris Duke Charitable FoundationOTHER
64 Previous Clinical Trials
264,398 Total Patients Enrolled
Stephanie K Tankou, MDPrincipal InvestigatorIcahn School of Medicine
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not received any treatment for my condition.I have an autoimmune disease like lupus, rheumatoid arthritis, or diabetes.I understand the risks and benefits of the trial and can consent.I have had surgery on my intestines before.I have used pre-/probiotics or corticosteroids in the last month.I have an eating disorder like anorexia, bulimia, or binge eating.I haven't had gastroenteritis recently and don't have chronic infections like hepatitis or HIV.I have irritable bowel syndrome or constipation.I am between 18 and 50 years old.I have been treated with drugs that lower my immune system.I cannot take vancomycin due to kidney issues, hearing problems, or an allergy.I was recently diagnosed with MS and started having symptoms within the last year.
Research Study Groups:
This trial has the following groups:- Group 1: Vancomycin
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Multiple Sclerosis Patient Testimony for trial: Trial Name: NCT05539729 — Phase 1
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