Trials / Active Not Recruiting
Active Not RecruitingNCT06301477
PRecisiOn Microbiome Directed ExtensiOn of Anti-TNFα Crohn's Disease ThErapy in Children: The PROMOTE Trial
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 45 (estimated)
- Sponsor
- Children's Hospital of Eastern Ontario · Academic / Other
- Sex
- All
- Age
- 8 Years – 16 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Resistant Starch | 7.5g/m2 or 5.0g/m2 (body surface area) resistant starch oral consumption |
| OTHER | Placebo | Placebo oral consumption of food-grade cornstarch |
Timeline
- Start date
- 2024-12-01
- Primary completion
- 2025-12-08
- Completion
- 2027-03-01
- First posted
- 2024-03-08
- Last updated
- 2026-01-29
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT06301477. Inclusion in this directory is not an endorsement.