Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 50
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
12 (estimated)
Sponsor
Icahn School of Medicine at Mount Sinai · Other
Who this trial is looking for
This trial is looking for people aged 18 to 50 who have recently been diagnosed with multiple sclerosis and are treatment naive. Participants will take vancomycin to see how it impacts their gut health and brain MRI results.
Are You a Good Fit for This Trial?
Rules you outIrritable bowel syndromeInflammatory bowel diseaseRheumatoid arthritisSystemic lupus erythematosusDiabetesAny other autoimmune illness
You may be able to join if
I am aged 18 to 50.
I have been newly diagnosed with multiple sclerosis.
I have experienced symptoms of MS no earlier than the past year.
I have not received any MS treatments before.
I can understand the risks and benefits of taking part.
You may not be able to join if
I have taken antibiotics in the past 90 days.
I have used pre- or probiotics in the past month.
I have used tobacco products in the past month.
I have a history of treatment with immunosuppressants.
I had gastroenteritis or any chronic infectious disease in the past month.
I am pregnant or less than 6 months postpartum.
I have a history of bowel surgery.
I have any other neurological or serious psychiatric conditions.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 v…
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.
Trial Locations
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Status
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 Cri…
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
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