NCT05539729RecruitingPhase 1
Vancomycin Study in Multiple Sclerosis (MS)
Impact of Vancomycin on the Gut Microbiome and Immune Function in Multiple Sclerosis
Source: ClinicalTrials.gov · Last updated 28 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 12 (estimated)
- First submitted
- 12 Sept 2022
- Start date
- 31 Jan 2023
- Primary completion date
- 30 Jun 2028
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Diseases
- Multiple sclerosis
- NCT number
- NCT05539729
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 12
- From 31 Jan 2023 to the primary completion date, 30 Jun 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- pre- or probiotic use within past month or corticosteroids use within the past month;
- history of treatment with immunosuppressants;
Other illness
- history of gastroenteritis within the past month or diagnosis with a chronic infectious disease, i.e. hepatitis B, C or HIV;
- 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;
- contraindication to vancomycin including estimated glomerular filtration rate of \<60ml/min, impaired hearing or known allergy.
Other
- antibiotic use within the past 90 days;
- use of tobacco products within the past 1 month;
- pregnancy or less than 6 months postpartum;
- travel outside of the country within the past month;
- Contraindication to MRI such as implanted metallic objects
Who the study is looking for
- 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
Age in the registry: 18 years to 50 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Corinne Goldsmith Dickinson Center for Multiple Sclerosis at Mount Sinai Coordinator of this site? Confirm its status | New York | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.