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Recruiting NCT05539729

Vancomycin Study in Multiple Sclerosis (MS)

Phase I Interventional Multiple Sclerosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Vancomycin, Placebo.
Who it may be relevant to
Registry conditions: Multiple Sclerosis. Basic parameters: 18 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • 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]
Secondary outcome measures (12)
  • Changes in abundance of short chain fatty acids (SCFAs)-producing bacteria [Time frame: Baseline and 12 months]
  • Change in stool SCFAs levels [Time frame: Baseline and 12 months]
  • Change in serum SCFAs levels [Time frame: Baseline and 12 months]
  • Change in number of gadolium enhancing brain lesions [Time frame: Baseline and 12 months]
  • Change in volume of gadolium enhancing brain lesions [Time frame: Baseline and 12 months]
  • Change in number of new brain lesions [Time frame: Baseline and 12 months]
  • Change in volume of new brain lesions [Time frame: Baseline and 12 months]
  • Change in number of total brain lesions [Time frame: Baseline and 12 months]
  • Change in volume of total brain lesions [Time frame: Baseline and 12 months]
  • Changes in number of paramagnetic rim lesions [Time frame: Baseline and 12 months]
  • Changes in volume of paramagnetic rim lesions [Time frame: Baseline and 12 months]
  • Changes in thalamic brain volumes [Time frame: Baseline and 12 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Corinne Goldsmith Dickinson Center for Multiple Sclerosis at Mount Sinai — New York

Identifiers

NCT: NCT05539729 · GCO-22-0462

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗