Developing New Patient-Reported Outcomes and Endoscopic Measures for Adults with Crohns Disease and Permanent Ileostomy

What this Trial Is About

Researchers are developing new tools to better understand and measure symptoms and disease activity in patients with Crohns Disease CD who have permanent ileostomies. These patients have often been excluded from clinical trials, so the study aims to create a Patient Reported Outcome PRO measure and an Endoscopic Index EI specifically for this group. The study plans to enroll about 50 adults diagnosed with CD and permanent ileostomies to help fill this gap in research. Participants will undergo ileoscopy procedures as part of their routine medical care, and videos from these endoscopies will be collected and centrally reviewed to identify inflammation features. These features will be used to develop the new Endoscopic Index. Additionally, participants will take part in interviews to share their symptoms and impacts of living with CD and an ileostomy, which will guide the creation of the PRO measure. Throughout the study, researchers will assess reliability of various scoring systems and measures, including the 100-mm Visual Analog Scale and several established endoscopic scores at baseline and after two weeks. The entire study period averages around one year. Participants involvement includes interviews and standard care endoscopy, with safety monitored as part of usual care. The study aims to ensure that tools developed reflect patient experiences and can be used in future clinical trials for this population.

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