Vancomycin for Multiple Sclerosis
Recruiting in Palo Alto (17 mi)
Overseen byStephanie K Tankou, MD
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
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
Trial Summary
What is the purpose of this trial?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.
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 vancomycin safe for humans?
Vancomycin is generally safe for humans, but it can cause some side effects like kidney issues, skin rash, and allergic reactions. These side effects are usually rare and can be managed by adjusting the treatment.
12345How does the drug Vancomycin differ from other drugs for multiple sclerosis?
Vancomycin is unique in the context of multiple sclerosis treatment because it is primarily an antibiotic, traditionally used to treat bacterial infections, and its potential use in MS is based on its ability to modulate the immune system. This is different from most MS treatments, which are specifically designed to target the immune system or inflammation directly.
678910Eligibility Criteria
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 am between 18 and 50 years old.
+1 more
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.
+11 more
Trial Timeline
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
Participant Groups
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.
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
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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Corinne Goldsmith Dickinson Center for Multiple Sclerosis at Mount SinaiNew York, NY
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Who Is Running the Clinical Trial?
Icahn School of Medicine at Mount SinaiLead Sponsor
Doris Duke Charitable FoundationCollaborator
References
Risk of hepatic events in patients treated with vancomycin in clinical studies: a systematic review and meta-analysis. [2021]Routine surveillance of spontaneous reporting data and subsequent disproportionality analyses have indicated that the use of vancomycin might be associated with an increased risk of hepatic events.
Monitoring vancomycin therapy. [2019]Vancomycin is an effective and widely used antistaphylococcal antibiotic. Despite several decades of use, however, our knowledge of the toxicologic and pharmacokinetic properties of vancomycin remains incomplete. This review summarizes current information regarding the adverse reactions and pharmacokinetics of vancomycin. Although there have been reports of side effects with vancomycin, these effects tend to be infrequent, easily managed, and reversible. Several methods for adjustment of vancomycin therapy have been recommended. The relationship between serum concentrations of vancomycin and the occurrence of ototoxicity or nephrotoxicity has not been well established. However, because of large interpatient variations in pharmacokinetic parameters, it seems preferable to individualize vancomycin therapy based on serum concentration data.
Adverse effects of vancomycin in children: a review of 22 cases. [2019]Vancomycin has been frequently recommended for the treatment of multi-resistant infections. Twenty-two children undergoing vancomycin treatment were observed. Nine adverse effects were registered in 6 children: eosinophilia in 5 cases, skin rash in 2 cases, and an increase in plasma creatinine in 2 cases. All adverse effects remitted with withdrawal of the drug.
Parenterally administered vancomycin in 29 dogs and 7 cats (2003-2017). [2021]Vancomycin is commonly used to treat resistant bacterial infections in people. Reported adverse effects of vancomycin in people include acute kidney injury (AKI), neutropenia, and systemic allergic reaction. Given the increased incidence of vancomycin-resistant bacterial infections in people, support is growing for restriction of vancomycin.
Vancomycin. [2019]Vancomycin is a narrow-spectrum bactericidal antibiotic used primarily for treatment of serious staphylococcal infections. It is the alternative therapy of choice when the penicillins and cephalosporins cannot be used. Vancomycin is also used in (1) methicillin-resistant Staphylococcus aureus infections; (2) streptococcal endocarditis in conjunction with an aminoglycoside in patients intolerant of penicillin or ampicillin; (3) infections, including those involving prosthetic devices, caused by gram-positive organisms with multiple antibiotic resistance; (4) antibiotic-induced enterocolitis caused by Clostridium difficile; and (5) prophylaxis for endocarditis in patients who are at risk and cannot tolerate a penicillin, cephalosporin, or erythromycin. The major toxic effect associated with the use of vancomycin is ototoxicity, which may develop when serum levels exceed 30 micrograms/ml.
Something Old, New, Borrowed, Blue: Anthracenedione Agents for Treatment of Multiple Sclerosis. [2016]This study aimed to present anthracenedione agents that have been used to treat multiple sclerosis (MS), problems related to their use, and knowledge gained from our experiences using these agents to develop more efficacious drugs with fewer adverse effects.
Clinical trials in multiple sclerosis. [2007]In this past year, there has only been modest progress in the search for an effective treatment for multiple sclerosis and its complications, although a number of carefully designed trials are in progress. No treatment predictably slows the course of active disease. The marginal benefits previously claimed for azathioprine have been strengthened by a meta-analysis of previously published work. Methylprednisolone may have a minor role in the treatment of very severe, acute optic neuritis but prednisone use may predispose patients to recurrent optic neuritis. 4-Aminopyridine and 3,4-diaminopyridine may prove useful for the symptomatic treatment of some multiple sclerosis patients; pemoline may be an alternative to amantadine for the control of fatigue; and acetazolamide may be an alternative to carbamazepine and phenytoin for the treatment of painful tonic spasms.
The prospects of minocycline in multiple sclerosis. [2022]Multiple sclerosis (MS) is the most common inflammatory demyelinating disease of the central nervous system (CNS). Although there are several approved drugs for MS, not all patients respond optimally to these drugs. More effective, well-tolerated therapeutic strategies for MS are necessary, either through the development of new medication or combination of existing ones. Minocycline is a traditional antibiotic with profound anti-inflammatory and neuroprotective effects and good tolerance for long-term use. The encouraging results from the animal model and clinical experiments on minocycline make it a promising candidate for MS treatment whether used alone or combined with other drugs. In this review, we summarized the pharmacological actions of minocycline and focused on its therapeutic effects and safety in experimental autoimmune encephalomyelitis (EAE) and MS. The data obtained here showed that minocycline would be an effective and safe therapy for MS.
From Animal Models to Clinical Trials: The Potential of Antimicrobials in Multiple Sclerosis Treatment. [2023]Multiple sclerosis (MS) is a chronic, autoimmune, demyelinating disease of the central nervous system (CNS). Microbes, including bacteria and certain viruses, particularly Epstein-Barr virus (EBV), have been linked to the pathogenesis of MS. While there is currently no cure for MS, antibiotics and antivirals have been studied as potential treatment options due to their immunomodulatory ability that results in the regulation of the immune process. The current issue addressed in this systematic review is the effect of antimicrobials, including antibiotics, antivirals, and antiparasitic agents in animals and humans. We performed a comprehensive search of PubMed, Google Scholar, and Scopus for articles on antimicrobials in experimental autoimmune encephalomyelitis animal models of MS, as well as in people with MS (pwMS). In animal models, antibiotics tested included beta-lactams, minocycline, rapamycin, macrolides, and doxycycline. Antivirals included acyclovir, valacyclovir, and ganciclovir. Hydroxychloroquine was the only antiparasitic that was tested. In pwMS, we identified a total of 24 studies, 17 of them relevant to antibiotics, 6 to antivirals, and 1 relevant to antiparasitic hydroxychloroquine. While the effect of antimicrobials in animal models was promising, only minocycline and hydroxychloroquine improved outcome measures in pwMS. No favorable effect of the antivirals in humans has been observed yet. The number and size of clinical trials testing antimicrobials have been limited. Large, multicenter, well-designed studies are needed to further evaluate the effect of antimicrobials in MS.
Tetracyclines Diminish In Vitro IFN-γ and IL-17-Producing Adaptive and Innate Immune Cells in Multiple Sclerosis. [2022]Limited data from clinical trials in multiple sclerosis (MS) reported that minocycline, a widely used antibiotic belonging to the family of tetracyclines (TCs), exerts a beneficial short-lived clinical effect A similar anti-inflammatory effect of minocycline attributed to a deviation from Th1 to Th2 immune response has been reported in experimental models of MS. Whether such an immunomodulatory mechanism is operated in the human disease remains largely unknown.