Vancomycin for Multiple Sclerosis

Overseen By Gena Persad

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Icahn School of Medicine at Mount Sinai

Must not be taking: Antibiotics, Corticosteroids, Immunosuppressants, others

Disqualifiers: Pregnancy, Diabetes, HIV, others

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

12 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how the antibiotic vancomycin affects the gut and brain in people with multiple sclerosis (MS). Researchers aim to determine if vancomycin can alter gut bacteria, impact immune system function, and influence brain lesions visible on MRIs. Participants will take either vancomycin or a placebo (a pill with no active medicine) four times a day. Ideal candidates for this trial are those recently diagnosed with MS, who have not started treatment, and have experienced symptoms for less than a year. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking research.

Will I have to stop taking my current medications?

The trial requires participants to be treatment naive, meaning you should not be on any current medications for multiple sclerosis. If you are taking antibiotics, pre- or probiotics, or corticosteroids, you must stop using them for a certain period before joining the trial.

Is there any evidence suggesting that vancomycin is likely to be safe for humans?

Research has shown that vancomycin is usually safe and effective for treating infections. Many people have used it safely for other health issues. Studies suggest that monitoring vancomycin levels in the body ensures safe use by maintaining the drug's levels within an optimal range—not too high or too low—to avoid complications.

Doctors often check vancomycin levels in patients, especially if used for more than two days, to maintain its safety and effectiveness. Although this study is in the early stages, vancomycin's past use in other conditions provides some reassurance about its safety. However, like any treatment, side effects can occur, so discussing any concerns with a healthcare provider is important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for MS?

Most treatments for multiple sclerosis focus on modulating the immune system, like interferons or monoclonal antibodies. But vancomycin offers a unique approach by using an antibiotic to potentially manage the condition. Researchers are excited about vancomycin because it could modify gut bacteria, which might play a role in immune system regulation and inflammation. This new angle could open up opportunities for treating MS by targeting gut health, offering a fresh perspective beyond traditional immune-targeting therapies.

What evidence suggests that vancomycin might be an effective treatment for multiple sclerosis?

Research suggests that vancomycin, which participants in this trial may receive, might influence the gut-brain connection in people with multiple sclerosis (MS). Studies have found that vancomycin can help protect the gut and alter the types of bacteria living there. This is important because gut bacteria are linked to inflammation in MS. By changing these bacteria, vancomycin might help reduce nerve inflammation related to MS. Although limited information exists from human studies on its use in MS, these early findings indicate a possible benefit. ^{2 3 6 7 8}

Who Is on the Research Team?

Stephanie K Tankou, MD

Principal Investigator

Icahn School of Medicine

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have not received any treatment for my condition.

I understand the risks and benefits of the trial and can consent.

I was recently diagnosed with MS and started having symptoms within the last year.

Exclusion Criteria

I have an autoimmune disease like lupus, rheumatoid arthritis, or diabetes.

Antibiotic use within the past 90 days

I have had surgery on my intestines before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive vancomycin or placebo for 6 weeks to study its effects on gut microbiota and immune function

6 weeks

Regular visits for monitoring and medication administration

Follow-up

Participants are monitored for changes in brain volumes and other secondary outcomes

12 months

Periodic visits for MRI and other assessments

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• Vancomycin

Trial Overview 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.

How Is the Trial Designed?

Group I: Vancomycin Experimental Treatment 1 Intervention

125mg antibiotic taken 4 times daily by mouth

Group II: Placebo Placebo Group 1 Intervention

Matching placebo taken 4 times daily by mouth

Vancomycin is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Vancocin for:

• Severe infections caused by susceptible strains of methicillin-resistant staphylococci
• Enterocolitis caused by Staphylococcus aureus
• Staphylococcal endocarditis

Approved in European Union as Vancomycin for:

• Severe infections caused by Gram-positive bacteria
• Endocarditis
• Peritonitis associated with continuous ambulatory peritoneal dialysis (CAPD)

Approved in Canada as Vancomycin for:

• Severe infections caused by susceptible strains of methicillin-resistant staphylococci
• Enterocolitis caused by Staphylococcus aureus

Approved in Japan as Vancomycin for:

• Severe infections caused by Gram-positive bacteria
• Endocarditis

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

Doris Duke Charitable Foundation

Collaborator

Trials

65

Recruited

264,000+

Published Research Related to This Trial

A meta-analysis of 20 randomized controlled trials involving 7419 patients found that vancomycin is associated with a nearly doubled risk of hepatic events, specifically elevated serum aminotransferase levels, compared to other treatments.

Most hepatic events linked to vancomycin were mild to moderate, and there is currently no evidence suggesting it causes severe drug-induced liver injury, indicating a need for ongoing monitoring of liver function in patients receiving this medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk of hepatic events in patients treated with vancomycin in clinical studies: a systematic review and meta-analysis. Chen, Y., Yang, XY., Zeckel, M., et al.[2021]

Vancomycin is generally safe with infrequent and manageable side effects, making it a reliable antibiotic for treating staphylococcal infections.

Due to significant variations in how patients metabolize vancomycin, it is recommended to tailor therapy based on individual serum concentration levels to optimize efficacy and minimize potential toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Monitoring vancomycin therapy. Rybak, MJ., Boike, SC.[2019]

In a study of 22 children treated with vancomycin for multi-resistant infections, 6 children experienced a total of 9 adverse effects, including eosinophilia, skin rash, and increased plasma creatinine levels.

All adverse effects were resolved after discontinuing the medication, indicating that while vancomycin can be effective, it may also lead to side effects that require monitoring and management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse effects of vancomycin in children: a review of 22 cases. Reis, AG., Grisi, SJ.[2019]

In a study of 36 animals (29 dogs and 7 cats) treated with intravenous vancomycin, acute kidney injury (AKI) occurred in 16.7% of cases, but it could not be definitively linked to the drug due to other complicating factors.

Adverse effects such as neutropenia and allergic reactions were not observed, suggesting that vancomycin is generally safe for use in dogs and cats, although alternative treatments may be available for many infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parenterally administered vancomycin in 29 dogs and 7 cats (2003-2017). DeStefano, IM., Wayne, AS., Rozanski, EA., et al.[2021]

Vancomycin is an effective antibiotic for treating serious staphylococcal infections, especially when other antibiotics like penicillins and cephalosporins cannot be used, making it a crucial alternative therapy.

While vancomycin is generally safe, it can cause ototoxicity if serum levels exceed 30 micrograms/ml, highlighting the importance of monitoring drug levels during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vancomycin. Hermans, PE., Wilhelm, MP.[2019]

Mitoxantrone, an anthracenedione used to treat multiple sclerosis (MS), has shown significant toxicity, including risks of cardiotoxicity and treatment-associated leukemia, making it less suitable for chronic use in MS patients.

Newer compounds like pixantrone and BBR3378 show promise for treating MS with potentially reduced toxicity, but further long-term studies are needed to assess their safety and efficacy before they can be widely used in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Something Old, New, Borrowed, Blue: Anthracenedione Agents for Treatment of Multiple Sclerosis. Koffman, BM., Hacker, M., Gunning, WT., et al.[2016]

There has been only modest progress in finding effective treatments for multiple sclerosis, with no current treatment reliably slowing the disease's progression, although ongoing trials may yield new insights.

Azathioprine has shown strengthened benefits for MS treatment through a meta-analysis, while methylprednisolone may help with severe optic neuritis, but prednisone could increase the risk of recurrent episodes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical trials in multiple sclerosis. Noseworthy, JH.[2007]

Minocycline, traditionally an antibiotic, has shown promising anti-inflammatory and neuroprotective effects in treating multiple sclerosis (MS), making it a potential new therapeutic option.

Research indicates that minocycline is well-tolerated for long-term use and could be effective either on its own or in combination with other MS treatments, suggesting it may improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The prospects of minocycline in multiple sclerosis. Chen, X., Ma, X., Jiang, Y., et al.[2022]

In a systematic review of 24 studies involving people with multiple sclerosis (MS), only minocycline (an antibiotic) and hydroxychloroquine (an antiparasitic) showed improvements in MS outcomes, while antivirals did not demonstrate any favorable effects.

Despite promising results from animal models regarding various antimicrobials, the limited number and size of clinical trials in humans highlight the need for larger, well-designed studies to better understand the potential of these treatments in MS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

From Animal Models to Clinical Trials: The Potential of Antimicrobials in Multiple Sclerosis Treatment. Raghib, MF., Bernitsas, E.[2023]

In a study involving 45 individuals, including 35 multiple sclerosis (MS) patients, minocycline and doxycycline were shown to significantly reduce the production of the inflammatory cytokine IFN-γ in certain immune cells, suggesting a potential immunomodulatory effect in MS.

The tetracyclines did not affect the viability of immune cells, indicating that their therapeutic effects may be due to their ability to suppress specific inflammatory responses without harming cell health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tetracyclines Diminish In Vitro IFN-γ and IL-17-Producing Adaptive and Innate Immune Cells in Multiple Sclerosis. Florou, DT., Mavropoulos, A., Dardiotis, E., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05539729?cond=Multiple%20Sclerosis&aggFilters=status:rec&viewType=Table&rank=9

NCT05539729 | Vancomycin Study in Multiple Sclerosis (MS) 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10616394/

Oral vancomycin treatment suppresses gut trypsin activity and ... Here we showed that vancomycin preserved the integrity of the intestinal barrier, while also suppressing gut trypsin activity, enhancing the relative abundance ...

3. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/369984

Vancomycin Study in Multiple Sclerosis (MS) The overall goal of this study is to elucidate a mechanism by which vancomycin modulates the gut-brain axis in multiple sclerosis (MS).

4. trialx.com trialx.com/clinical-trials/listings/282106/vancomycin-study-in-multiple-sclerosis-ms/

Vancomycin Study in Multiple Sclerosis (MS) 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 ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2000794/

Approaching and analyzing a large literature on ... These investigators established that a serum vancomycin concentration of 2.5 mcg/mL completely inhibited 110 of 112 strains of M. Pyogenes.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05539729?cond=%22Multiple%20Sclerosis%22&intr=%22Vancomycin%22&viewType=Table&rank=1

Vancomycin Study in Multiple Sclerosis (MS) Types of outcome measures include primary outcome measure and secondary outcome measure. ... A type of intervention model describing a clinical trial in which two ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12055491/

Safe and effective use of vancomycin - PMC - PubMed Central Therapeutic drug monitoring is recommended for all patients expected to receive vancomycin for more than 48 hours to optimise drug exposure.

8. contagionlive.com contagionlive.com/view/vancomycin-loading-doses-improve-time-to-target-and-maintain-safety-in-over-61-000-cases

Vancomycin Loading Doses Improve Target Timing and ... Patients who received a vancomycin loading dose, defined as ≥250 mg or ≥5 mg/kg larger than the second dose, achieved therapeutic exposure significantly faster.