Resistant Starch in Pediatric Inflammatory Bowel Disease (Crohn's Disease or Ulcerative Colitis)
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Crohn Disease
- Inflammatory Bowel Diseases
- Ulcerative Colitis
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: A single center, randomized, placebo-controlled, double-blinded, parallel, pilot clinical trialMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: Unblinding will occur only if necessary to ensure study participants safety, interim analysis at 5 ± 1 months, or eligibility for our associated open label trial (OARS trial). Only Dr. Mack (Co-PI) can request to break the blind for safety reasons or eligibility for the OARS Trial; only Dr Stintzi (Co-PI) will request to break the blind for interim analysis. Once the blind is broken, the patient will be discontinued from study product.Primary Purpose: Basic Science
Participation Requirements
- Age
- Between 5 years and 17 years
- Gender
- Both males and females
Description
Not Provided
Not Provided
Tracking Information
- NCT #
- NCT04522271
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: David Mack, MD, FRCPC Children's Hospital of Eastern Ontario Principal Investigator: Alain Stintzi, PhD University of Ottawa
Get Well Soon