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Vancomycin Study in Multiple Sclerosis (MS)

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 years 2 months later Mar 2026 → Jun 2028
See other at-risk trials from Icahn School of Medicine at Mount Sinai

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Mar 2026 to Jun 2028
    • Study completion pushed from Sep 2026 to Dec 2028
    • Eligibility criteria expanded, about 18 words
    • Secondary endpoints: details revised at 3 of 14 entries
  2. Re-verified, no change to tracked fieldsv9
  3. Primary completion date: Dec 2026 to Mar 2026
    • Study completion date: Dec 2027 to Sep 2026
    • Start date: Feb 8, 2023 to Jan 31, 2023
    v8
  4. Enrollment target: 40 to 12
    • Primary completion date: Mar 2024 to Dec 2026
    • Study completion date: Sep 2024 to Dec 2027
    v7
  5. Eligibility criteria shortened, about 3 wordsv6
Show 4 earlier versionsHide 4 earlier versions
  1. Start date changed from estimate of Jan 2023 to Feb 8, 2023v5
  2. Start date: Nov 8, 2022 to Jan 2023v4
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Nov 2022 to Nov 8, 2022
    • Site details revised
    v3
  4. Start date: Sep 2022 to Nov 2022v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT05539729
Lead Sponsor Icahn School of Medicine at Mount Sinai
Collaborators: Doris Duke Charitable Foundation
Conditions
(from sponsor)		 Multiple Sclerosis
Related terms Multiple Sclerosis, Neuroinflammatory Diseases
Enrollment 12 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov