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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: f
View:

• 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

Locations
United States
New York
Corinne Goldsmith Dickinson Center for Multiple Sclerosis at Mount Sinai
RECRUITING
New York
Contact Information
Primary
Susan E Filomena, BA
susan.filomena@mssm.edu
212-2413841
Backup
Gena Persad
gena.persad@mssm.edu
212-241-6604
Time Frame
Start Date: 2023-01-31
Estimated Completion Date: 2026-09
Participants
Target number of participants: 12
Treatments
Experimental: Vancomycin
125mg antibiotic taken 4 times daily by mouth
Placebo_comparator: Placebo
Matching placebo taken 4 times daily by mouth
Related Therapeutic Areas
Sponsors
Collaborators: Doris Duke Charitable Foundation
Leads: Icahn School of Medicine at Mount Sinai

This content was sourced from clinicaltrials.gov