NCT04522271

Resistant Starch in Pediatric Inflammatory Bowel Disease (Crohn's Disease or Ulcerative Colitis)

A Single Center, Randomized, Placebo-controlled, Double-blinded, Parallel, Pilot Clinical Trial to Assess Plant-derived Food-based Resistant Starches Individually Optimized for Patients With Crohn's Disease (CD) or Ulcerative Colitis (UC)

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Children's Hospital of Eastern Ontario · Academic / Other
• Sex: All
• Age: 5 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is determine if a plant-based resistant starch that is optimized for the individual will target the underlying cause of inflammatory bowel disease and restore a "healthier" gut microbiome in pediatric participants with inflammatory bowel disease.

Conditions

• Crohn Disease
• Ulcerative Colitis
• Inflammatory Bowel Diseases

Interventions

Type	Name	Description
OTHER	Resistant Starch	7.5 g resistant starch/m2 oral consumption
OTHER	Placebo	Placebo oral consumption of food-grade cornstarch

Timeline

• Start date: 2020-08-25
• Primary completion: 2024-05-25
• Completion: 2026-12-31
• First posted: 2020-08-21
• Last updated: 2026-01-29

Locations

1 site across 1 country: Canada