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PRecisiOn Microbiome Directed ExtensiOn of Anti-TNFα Crohn's Disease ThErapy in Children: The PROMOTE Trial

Study acronym: PROMOTE
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Not Yet Recruiting to Active, Not Recruiting
    • Primary completion date changed from estimate of Mar 1, 2027 to Dec 8, 2025
    • Start date changed from estimate of Jun 2025 to Dec 1, 2024
    • Site contact updated
    v5
  2. Start date: Sep 30, 2024 to Jun 2025v4
  3. Start date: Apr 1, 2024 to Sep 30, 2024v3
  4. Primary completion date: Jul 1, 2025 to Mar 1, 2027
    • Study completion date: Dec 31, 2025 to Mar 1, 2027
    • Start date: Jun 1, 2024 to Apr 1, 2024
    v2
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
To determine whether a specific food-origin plant-derived resistant starch (RS) optimized for the individual will increase the abundance of known butyrate producing microbes.
Trial Details
NCT Number NCT06301477
Lead Sponsor Children's Hospital of Eastern Ontario
Conditions
(from sponsor)		 Inflammatory Bowel Diseases, Crohn Disease
Related terms Crohn Disease, Inflammatory Bowel Diseases
Enrollment 45 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov