Recruiting
Phase 1

Vancomycin

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT05539729

Conditions

Multiple Sclerosis

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Not accepted

Interventions

Vancomycin

Placebo

Study Details

Brief 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.

Conditions

Multiple Sclerosis

Study ID

NCT05539729

Start date

Jan 31, 2023

Status verified date

Apr, 2025

Completion date

Sep, 2026

Anticipated

Primary completion date

Mar, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

12 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Vancomycin

125mg antibiotic taken 4 times daily by mouth

placebo comparator: Placebo

Matching placebo taken 4 times daily by mouth

Interventions

Vancomycin

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

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

Primary outcome measure

  • Changes in abundance of butyrate producing bacteria [ Time Frame: Baseline up to 6 weeks ]
  • Changes in Serum Butyrate levels [ Time Frame: Baseline up to 6 weeks ]
  • Changes in number of peripheral T cells [ Time Frame: Baseline up to 6 weeks ]

Central Contacts and Locations

Central contacts

Susan E Filomena, BA

212-2413841susan.filomena@mssm.edu

Gena Persad

212-241-6604gena.persad@mssm.edu

Locations

Corinne Goldsmith Dickinson Center for Multiple Sclerosis at Mount Sinai

Recruiting

New York, New York, United States, 10029

Contacts

Susan E Filomena, BA

212-241-3841susan.filomena@mssm.edu

Abigail Hintermeister, MPA

212-241-3391abigail.hintermeister@mssm.edu

Principal Investigator:

Stephanie K Tankou

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

Sep 10, 2025

Last verified

Apr, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2025-09-10.