NCT05539729 Vancomycin Study in Multiple Sclerosis (MS)
| NCT ID | NCT05539729 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Icahn School of Medicine at Mount Sinai |
| Condition | Multiple Sclerosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2023-01-31 |
| Primary Completion | 2026-03 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 12 participants in total. It began in 2023-01-31 with a primary completion date of 2026-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Stephanie K Tankou, MD
PRINCIPAL INVESTIGATOR
Icahn School of Medicine
Frequently Asked Questions
Who can join the NCT05539729 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 50 Years, studying Multiple Sclerosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05539729 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05539729 currently recruiting?
Yes, NCT05539729 is actively recruiting participants. Contact the research team at susan.filomena@mssm.edu for enrollment information.
Where is the NCT05539729 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT05539729 clinical trial?
NCT05539729 is sponsored by Icahn School of Medicine at Mount Sinai. The principal investigator is Stephanie K Tankou, MD at Icahn School of Medicine. The trial plans to enroll 12 participants.
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