🏛️ Verified NIH Record • Updated 2026-01-28
PRecisiOn Microbiome Directed ExtensiOn of Anti-TNFα Crohn's Disease ThErapy in Children: The PROMOTE Trial (NCT06301477)
🔵 Active, Not Recruiting Observational / Diagnostic 📋 Clinical Research Protocol Sponsor: Children's Hospital of Eastern Ontario
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Children's Hospital of Eastern Ontario — Ottawa, Ontario
Age range: 8 Years to 16 Years
🧪 Interventions in This Study
- Resistant Starch (OTHER)
- Placebo (OTHER)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- Children's Hospital of Eastern Ontario — Ottawa, Ontario
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Inflammatory Bowel Diseases
- Implementing a Multimodal RCT Intervention to Improve the Transition of Patients With Crohn's Disease From Pediatric to Adult Care — Vancouver, British Columbia
- A Novel Remote Patient and Medication Monitoring Solution to Improve Adherence and PerSiStence With IBD Therapy — Baltimore, Maryland
- Outpatient VR (Virtual Reality)-Brain-gut Behavioral Therapies (BGBT) in Inflammatory Bowel Disease (IBD) — Ann Arbor, Michigan
- A 5-year Longitudinal Observational Study of Patients Undergoing Therapy for Inflammatory Bowel Disease — Lancaster, California
- A Study to Evaluate MORF-057 in Adults With Moderately to Severely Active UC — Sun City, Arizona
Explore by condition: All Inflammatory Bowel Diseases clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.