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Standardized Microbiota Transplant Therapy in Crohn's Disease

StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Study sites: 2 to 3v8
  2. Eligibility criteria revisedv7
  3. Study sites: 1 to 2v6
  4. Re-verified, no change to tracked fieldsv5
  5. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v4
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  1. Start date: Nov 15, 2024 to Jan 15, 2025
    • Primary and study completion dates: May 15, 2029 to Jun 15, 2029
    v3
  2. Re-verified, no change to tracked fieldsv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Crohn's disease (CD) develops because of a disruption of homeostasis between the gut microbiota and the host immune system resulting in excessive inflammation in the intestinal tract. Current drug therapies for CD are directed at the immune system. The emergence of fecal microbiota transplantation (FMT) for the treatment of recurrent C. difficile infections (rCDI) has opened a frontier of restorative therapies targeting the gut microbiome. This study aims to assess if two forms of encapsulated FMT material (MTP101C and MTP101S) can effectively engraft in the ileum and colon of individuals with CD. This study will also assess how the impact of CD phenotype impacts engraftment. Finally this study will explore symptom and endoscopic changes before and after these two therapies.
Trial Details
NCT Number NCT06631586
Lead Sponsor University of Minnesota
Conditions
(from sponsor)		 Crohn Disease
Related terms Crohn Disease
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov