Clinical Trial

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

Study acronym: PROMOTE
Active, Not Recruiting
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Summary
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.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2024-03-02; most recent amendment 2026-01-28.
Status change: Not Yet Recruiting → Active, Not Recruiting 2026-01-28
Trial Details
NCT Number NCT06301477
Lead Sponsor Children's Hospital of Eastern Ontario
Conditions Inflammatory Bowel Diseases, Crohn Disease
Enrollment 45 participants
Start Date 2024-12-01
Primary Completion 2025-12-08 (estimated)
Study Completion 2027-03-01 (estimated)
Updated on ClinicalTrials.gov 2026-01-29