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ACTIVE NOT RECRUITING
NCT06301477
NA

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

Sponsor: Children's Hospital of Eastern Ontario

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

8 Years - 16 Years

Study Type

INTERVENTIONAL

Enrollment

45

Start Date

2024-12-01

Completion Date

2027-03-01

Last Updated

2026-01-29

Healthy Volunteers

No

Interventions

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

Locations (1)

Children's Hospital of Eastern Ontario

Ottawa, Ontario, Canada