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RecruitingNCT05539729Updated Sep 28, 2026

Vancomycin Study in Multiple Sclerosis (MS)

A Phase 1 interventional study of Vancomycin and Placebo in Multiple Sclerosis, sponsored by Icahn School of Medicine at Mount Sinai. Recruiting at 1 site in United States. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-09-28.

Sponsored by Icahn School of Medicine at Mount Sinai · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Multiple Sclerosis

Keywords

  • gut microbiome
  • peripheral immune function
  • neuroinflammation
  • gut-brain axis
03

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
12 participants (estimated)

Study arms

  • Experimental
    Vancomycin

    125mg antibiotic taken 4 times daily by mouth

    Drug: Vancomycin

  • Placebo comparator
    Placebo

    Matching placebo taken 4 times daily by mouth

    Drug: Placebo

Interventions

  • DrugVancomycin

    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.

  • DrugPlacebo

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

05

What researchers measure

Primary outcomes

  1. Changes in abundance of butyrate producing bacteria

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

    Time frame: Baseline up to 6 weeks

  2. Changes in Serum Butyrate levels

    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.

    Time frame: Baseline up to 6 weeks

  3. Changes in number of peripheral T cells

    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.

    Time frame: Baseline up to 6 weeks

Secondary outcomes

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

    Changes in abundance of SCFA-producing bacteria

    Time frame: Baseline and 12 months

  2. Change in stool SCFAs levels

    Change in stool SCFAs levels SCFAs are substance that are produce when gut bacteria breaks down food.

    Time frame: Baseline and 12 months

  3. Change in serum SCFAs levels

    Change in serum SCFAs levels

    Time frame: Baseline and 12 months

  4. Change in number of gadolium enhancing brain lesions

    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.

    Time frame: Baseline and 12 months

  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

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

    Time frame: Baseline and 12 months

  11. Changes in volume of paramagnetic rim lesions

    Changes in volume of paramagnetic rim lesions

    Time frame: Baseline and 12 months

  12. Changes in thalamic brain volumes

    Changes in thalamic brain volumes

    Time frame: Baseline and 12 months

  13. Changes in cortical brain volumes

    Changes in cortical brain volumes

    Time frame: Baseline and 12 months

  14. Changes in total brain volumes

    Changes in total brain volumes

    Time frame: Baseline and 12 months

06

Study locations

1 of 1 sites recruiting
  • Corinne Goldsmith Dickinson Center for Multiple Sclerosis at Mount Sinai
    New York, New York 10029, United States
    Recruiting
07

References and documents

Individual participant data

Plan to share: No — The investigator is not developing the product. The study has been exempted from an IND by the FDA, since it entails the off-label use of a marketed drug.

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT05539729
Lead sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
Doris Duke Charitable Foundation
Responsible party
Stephanie K Tankou (Assistant Professor, Neurology, Icahn School of Medicine at Mount Sinai) — Principal investigator
First posted
Sep 14, 2022
Start date
Jan 31, 2023
Primary completion
Jun 2028 (estimated)
Completion
Dec 2028 (estimated)
Last update
Sep 28, 2026

Study contacts

Susan E Filomena, BA
Contact
susan.filomena@mssm.edu
212-2413841
Gena Persad
Contact
gena.persad@mssm.edu
212-241-6604
Stephanie K Tankou, MD
principal investigator · Icahn School of Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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