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

Launched by ALIMENTIV INC. · Oct 31, 2024

Keywords

ClinConnect Summary

This clinical trial is focused on developing new tools to better understand the experiences of patients with Crohn's Disease (CD) who have a permanent ileostomy, which is a surgical opening in the abdomen for waste removal. Currently, these patients are often left out of clinical trials for new treatments because we lack effective ways to measure their symptoms and health outcomes. The study aims to create a Patient Reported Outcome (PRO) measure and an Endoscopic Index (EI) that can accurately reflect their health status and the severity of inflammation in their intestines. To do this, the trial will involve about 50 participants who will undergo routine ileoscopy procedures, and the researchers will also conduct interviews to gather insights about the symptoms and impacts that matter most to the patients.

To be eligible for this study, participants must be adults aged 18 or older who have had a permanent ileostomy for at least 12 months due to Crohn's Disease. They should be planning to have an ileoscopy as part of their regular medical care and be able to communicate in English. Participants will be asked to share their experiences and opinions, which will help shape the new measurement tools. This is an exciting opportunity to contribute to research that could lead to better treatments and support for people with Crohn's Disease in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Adults (age ≥ 18 years) with a diagnosis of CD treated surgically with subtotal colectomy/proctocolectomy end ileostomy at least 12 months prior to the scheduled endoscopy procedure.
• • 2. Planning to have an ileoscopy procedure scheduled as part of routine medical care.
• • 3. Be proficient in the English language (ie, ability to read, write, speak, and understand English well enough to take part in the interview process without the aid of an interpreter).
• • 4. Able and willing to participate fully in all aspects of this study.
• • 5. Written informed consent must be obtained and documented.
• Exclusion Criteria:
• • 1. End or loop colostomy, end ileostomy for UC, continent ileostomy, ileal pouch anal anastomosis, end ileostomy with mucous fistula, double barrel ileostomy, urostomy, loop ostomy, or any type of end ileostomy not considered permanent at the time of enrolment (with no intent to restore continuity).
• • 2. Peristomal skin complications such as pyoderma gangrenosum, abscess, or any other severe peristomal skin inflammation.
• • 3. Stomal stenosis obviating ileoscopy, known small bowel stricture, major stoma prolapse, symptomatic parastomal hernia, parastomal hernia with subcutaneous loops of small bowel within the hernia, stoma in a crease/poorly fitting applicable resulting in severe peristomal skin irritation, or retracted stoma that prevents endoscopic evaluation.
• • 4. Any actively draining fistula (eg, peristomal or peri-anal).
• • 5. Evidence of a known small bowel stricture on cross-sectional imaging or inability to pass an endoscope within the past 6 months.
• • 6. Known active Clostridoides difficile or other enteric infection.
• • 7. Short bowel syndrome.
• • 8. Predominant symptom(s) arising from a retained rectal stump.
• • 9. Serious underlying disease other than CD that in the opinion of the investigator may interfere with the participant's ability to participate fully in the study procedures or provide nonconfounded descriptions of their CD and ostomy symptom experiences during the interview.
• • 10. Prior enrolment in the current study.