Oral FMT (Fecal Microbial Transplant) in Subjects With Multiple Sclerosis

StatusCompleted
PhaseEarly Phase 1
Started

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Record History

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  1. Primary completion pushed from Sep 21, 2023 to Dec 21, 2024 Show 4 more changesShow less
    • Trial completed
    • Eligibility criteria expanded, about 37 words
    • Secondary endpoints: details revised at 6 of 7 entries
    • Study description expanded, about 7 words
  2. Primary completion date changed from estimate of Dec 30, 2023 to Sep 21, 2023
    • Study completion date: Dec 30, 2023 to Dec 30, 2024
    • Collaborators: 2 to 1
    v6
  3. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 15 to confirmed 9
    • Site details revised
    v5
  4. Primary and study completion dates: Dec 30, 2022 to Dec 30, 2023
    • Eligibility criteria expanded, about 19 words
    • Site contact updated
    v4
  5. Primary completion date: Jun 30, 2020 to Dec 30, 2022
    • Study completion date: Sep 30, 2020 to Dec 30, 2022
    • Secondary endpoints revised (7)
    v3
  6. Start date changed from estimate of Oct 14, 2019 to Oct 28, 2019
    • Secondary endpoints revised (7)
    v2
  7. Study First Submitted
  • 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 goal of this pilot study is to determine whether fecal microbial transplant (FMT) has the potential to be an effective, safe and tolerable therapy for the treatment of multiple sclerosis (MS). The investigators plan to gather preliminary data in a small cohort of 10 to 15 adults with MS.
Trial Details
NCT Number NCT04096443
Lead Sponsor Griffin Hospital
Collaborators: Yale-Griffin Prevention Research Center
Conditions
(from sponsor)		 Multiple Sclerosis
Related terms Multiple Sclerosis
Enrollment 9 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov