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NCT Number: 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 plays an important role in autoimmunity, including MS. However, the identity of gut microbes modulating neuroinflammation in MS and their mechanisms of action remain obscure. Hence, here the research team proposes to investigate the effects of vancomycin on the gut microbiota composition, peripheral immune function, and brain MRI lesions in MS patients.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Corinne Goldsmith Dickinson Center for Multiple Sclerosis at Mount Sinai

New York, 10029, United States

Location status: Recruiting

Location contact

Abigail Hintermeister, MPA

CONTACT

[email protected]

212-241-3391

Stephanie K Tankou

PRINCIPAL_INVESTIGATOR

Susan E Filomena, BA

CONTACT

[email protected]

212-241-3841

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vancomycin

Drug

A marketed antibiotic (Study Drug) supplied by Amerisource Bergen, by the Mount Sinai Investigational Drug Services (IDS), and encapsulated in red coating to match the placebo.

Placebo

Drug

Placebo created by the IDS and encapsulated in red coating to match the Study Drug.

Primary outcomes

  1. Changes in abundance of butyrate producing bacteria

    Time frame: Baseline up to 6 weeks

    Changes in abundance of butyrate producing bacteria from baseline treatment up to 6 weeks

  2. Changes in Serum Butyrate levels

    Time frame: Baseline up to 6 weeks

    Changes in serum butyrate level from baseline treatment up to 6 weeks

    Butyrate is a substance that is produce when gut bacteria breaks down food. Butyrate can get into our blood circulation and regulate how our immune cells function.

  3. Changes in number of peripheral T cells

    Time frame: Baseline up to 6 weeks

    Change in frequency of peripheral regulatory T cells baseline treatment up to 6 weeks.

    T cells are a type of lymphocyte. Lymphocytes are a type of white blood cell. They make up part of the immune system. T cells help the body fight diseases or harmful substances, such as bacteria or viruses.

Secondary outcomes

  1. Changes in abundance of short chain fatty acids (SCFAs)-producing bacteria

    Time frame: Baseline and 12 months

    Changes in abundance of SCFA-producing bacteria

  2. Change in stool SCFAs levels

    Time frame: Baseline and 12 months

    Change in stool SCFAs levels

    SCFAs are substance that are produce when gut bacteria breaks down food.

  3. Change in serum SCFAs levels

    Time frame: Baseline and 12 months

    Change in serum SCFAs levels

  4. Change in number of gadolium enhancing brain lesions

    Time frame: Baseline and 12 months

    Change in number gadolium enhancing brain lesions

    A lesion is a brain injury caused by inflammation. Gadolinium is a dye that is used to visualize areas of active inflammation in the brain.

  5. Change in volume of gadolium enhancing brain lesions

    Time frame: Baseline and 12 months

  6. Change in number of new brain lesions

    Time frame: Baseline and 12 months

  7. Change in volume of new brain lesions

    Time frame: Baseline and 12 months

  8. Change in number of total brain lesions

    Time frame: Baseline and 12 months

  9. Change in volume of total brain lesions

    Time frame: Baseline and 12 months

  10. Changes in number of paramagnetic rim lesions

    Time frame: Baseline and 12 months

    Changes in number of paramagnetic rim lesions

    Paramagnetic rim lesions are a type of brain injury found in MS patients.

  11. Changes in volume of paramagnetic rim lesions

    Time frame: Baseline and 12 months

    Changes in volume of paramagnetic rim lesions

  12. Changes in thalamic brain volumes

    Time frame: Baseline and 12 months

    Changes in thalamic brain volumes

  13. Changes in cortical brain volumes

    Time frame: Baseline and 12 months

    Changes in cortical brain volumes

  14. Changes in total brain volumes

    Time frame: Baseline and 12 months

    Changes in total brain volumes

Study contacts

Contact information is provided by the study sponsor or research team.

Gena Persad

CONTACT

[email protected]

212-241-6604

Susan E Filomena, BA

CONTACT

[email protected]

212-2413841

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Collaborators

  • Doris Duke Charitable Foundation

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Sep 14, 2022
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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