Investigating vancomycin's effects on multiple sclerosis

Impact of Vancomycin on the Gut Microbiome and Immune Function in Multiple Sclerosis

This study is testing if the antibiotic vancomycin can change gut bacteria and help improve symptoms in people who have just been diagnosed with multiple sclerosis.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Ages: 18 Years to 50 Years
• Sex: All
• Sponsor: Icahn School of Medicine at Mount Sinai (Academic / other)
• Locations: 1 site (New York, New York)
• Trial ID: NCT05539729 on ClinicalTrials.gov

What this trial studies

This study aims to explore how vancomycin influences the gut-brain axis in patients with multiple sclerosis (MS). It will assess the impact of vancomycin on gut microbiota composition, peripheral immune function, and brain MRI lesions in newly diagnosed MS patients. By understanding these mechanisms, the research seeks to clarify the role of gut microbes in neuroinflammation associated with MS. Participants will be randomly assigned to receive either vancomycin or a placebo.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 50 who have been newly diagnosed with multiple sclerosis and are treatment naive.

Not a fit: Patients with a history of other autoimmune diseases or recent antibiotic use may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to new therapeutic strategies for managing multiple sclerosis by targeting the gut microbiome.

How similar studies have performed: While the role of the gut microbiome in MS is being explored, this specific approach using vancomycin is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

* aged 18 - 50
* newly diagnosed MS (2017 McDonald criteria), CIS or RIS patients, who have experienced symptoms no earlier than the past year
* treatment naive
* able to understand the risks, benefits, and alternatives of participation and give meaningful consent

Exclusion Criteria:

* antibiotic use within the past 90 days;
* pre- or probiotic use within past month or corticosteroids use within the past month;
* use of tobacco products within the past 1 month;
* history of treatment with immunosuppressants;
* history of gastroenteritis within the past month or diagnosis with a chronic infectious disease, i.e. hepatitis B, C or HIV;
* pregnancy or less than 6 months postpartum;
* irritable bowel syndrome and other bowel dysfunction such as constipation;
* history of bowel surgery;
* inflammatory bowel disease, rheumatoid arthritis, systemic lupus erythematosus, diabetes and any other auto-immune illness;
* diagnosis with another neurological disease, behavioral or psychiatric conditions that would be incompatible with a safe and successful participation in the study (such as severe major depression, schizophrenia and presence of psychotic symptoms);
* eating disorders such as anorexia nervosa, bulimia, or binge eating syndrome;
* travel outside of the country within the past month;
* contraindication to vancomycin including estimated glomerular filtration rate of \<60ml/min, impaired hearing or known allergy.
* Contraindication to MRI such as implanted metallic objects

Where this trial is running

New York, New York

• Corinne Goldsmith Dickinson Center for Multiple Sclerosis at Mount Sinai — New York, New York, United States (Recruiting)

Study contacts

• Principal investigator: Stephanie K Tankou, MD — Icahn School of Medicine
• Study coordinator: Susan E Filomena, BA

Conditions Multiple Sclerosis; gut microbiome; peripheral immune function; neuroinflammation; gut-brain axis