RecruitingNCT06670638

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

Sponsor

Alimentiv Inc.

Enrollment

50 participants

Start Date

Jun 19, 2024

Study Type

OBSERVATIONAL

Conditions

Crohns Disease

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is developing a new scoring system for evaluating Crohn's disease (an inflammatory bowel condition) in the small intestine of people who have had their colon removed and live with a permanent ileostomy (a stoma). It also develops a patient questionnaire to capture daily symptom experience. No new treatments are given. **You may be eligible if...** - You are 18 or older with Crohn's disease and a permanent ileostomy following colon removal at least 12 months ago - You are scheduled for a routine ileoscopy (camera examination through the stoma) - You can read, write, and speak English fluently **You may NOT be eligible if...** - You have a different type of stoma (e.g., colostomy, loop ostomy, or temporary stoma) - You have active skin problems around your stoma, severe stoma complications, or internal strictures that prevent camera examination - You have an active bowel infection - You have short bowel syndrome or another serious condition that would interfere with participation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.