Development of a Novel Endoscopic Index and Patient-reported Outcome Measure for Clinical Trials in Participants With Permanent Ileostomy

To date, patients with Crohn's Disease (CD) and permanent ileostomies have been excluded from clinical trials for new treatments. To allow this patient population to be included in clinical trials, outcome and measurement tools are needed. This study aims to develop a Patient Reported Outcome (PRO) and Endoscopic Index (EI) for patients with Crohn's Disease (CD) and permanent ileostomy. The study will enroll about 50 participants and collect videos of endoscopies that are done as part of standard of care. The videos will be centrally read to identify features that represent a broad range of inflammation and will be used to develop the EI. Participants will also be asked to participate in interviews, to understand the symptoms and impacts that are most important to participants for the development of a PRO.

NCT Number	NCT06670638
Lead Sponsor	Alimentiv Inc. Collaborators: University of Western Ontario, Canada, The Leona M. and Harry B. Helmsley Charitable Trust, The Cleveland Clinic, OPEN Health (Pharmerit)
Conditions	Crohns Disease
Enrollment	50 participants
Start Date	2024-06-19
Primary Completion	2026-06-30 (estimated)
Study Completion	2027-02-28 (estimated)
Updated on ClinicalTrials.gov	2025-11-12