Vancomycin Study in Multiple Sclerosis (MS)
Impact of Vancomycin on the Gut Microbiome and Immune Function in Multiple Sclerosis
What it found
No result yet.
What was tested
Treatment tested
- Vancomycin
Peptidoglycan inhibitor
Placebo
- Placebo
What it measured
Main measures
Changes in abundance of butyrate producing bacteria
Baseline up to 6 weeks
Changes in Serum Butyrate levels
Baseline up to 6 weeks
Immune responseChanges in number of peripheral T cells
Baseline up to 6 weeks
Immune response
Other measures (14)
Changes in abundance of short chain fatty acids (SCFAs)-producing bacteria
Baseline and 12 months
Change in stool SCFAs levels
Baseline and 12 months
Change in serum SCFAs levels
Baseline and 12 months
Change in number of gadolium enhancing brain lesions
Baseline and 12 months
MRI lesionsChange in volume of gadolium enhancing brain lesions
Baseline and 12 months
MRI lesionsChange in number of new brain lesions
Baseline and 12 months
MRI lesionsChange in volume of new brain lesions
Baseline and 12 months
MRI lesionsChange in number of total brain lesions
Baseline and 12 months
MRI lesionsChange in volume of total brain lesions
Baseline and 12 months
MRI lesionsChanges in number of paramagnetic rim lesions
Baseline and 12 months
MRI lesionsSmouldering inflammation
Who could take part
Early (CIS/RIS) · 18 to 50
Show the full 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
As registered. Criteria can change, so ask the trial team or your neurologist.
Contact details on the registryAbout this trial
In the sponsor's words
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.
Papers
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History
Started
Jan 2023
Main results due
Jun 2028
Finished
Dec 2028