Actively Recruiting
Development of a Novel Endoscopic Index and Patient-reported Outcome Measure for Clinical Trials in Participants With Permanent Ileostomy
Led by Alimentiv Inc. · Updated on 2025-11-12
50
Participants Needed
5
Research Sites
140 weeks
Total Duration
On this page
Sponsors
A
Alimentiv Inc.
Lead Sponsor
U
University of Western Ontario, Canada
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Development of a Novel Endoscopic Index and Patient-reported Outcome Measure for Clinical Trials in Participants With Permanent Ileostomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults (age 65 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.
- Planning to have an ileoscopy procedure scheduled as part of routine medical care.
- Be proficient in the English language (ability to read, write, speak, and understand English well enough to take part in the interview process without an interpreter).
- Able and willing to participate fully in all aspects of this study.
- Written informed consent must be obtained and documented.
You will not qualify if you...
- 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 end ileostomy not considered permanent at enrollment with no intent to restore continuity.
- Peristomal skin complications such as pyoderma gangrenosum, abscess, or severe peristomal skin inflammation.
- Stomal stenosis preventing ileoscopy, known small bowel stricture, major stoma prolapse, symptomatic parastomal hernia with subcutaneous small bowel loops, stoma in crease or poorly fitting causing severe skin irritation, or retracted stoma preventing endoscopic evaluation.
- Any actively draining fistula (peristomal or peri-anal).
- Known small bowel stricture on imaging or inability to pass an endoscope within past 6 months.
- Known active Clostridoides difficile or other enteric infection.
- Short bowel syndrome.
- Predominant symptoms from a retained rectal stump.
- Serious diseases other than CD that may interfere with study participation or symptom reporting.
- Prior enrollment in this study.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Mayo Clinic- Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
2
Washington University in St Louis School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
3
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Actively Recruiting
4
McMaster University Medical Centre
Hamilton, Ontario, Canada, L6S 0E2
Actively Recruiting
5
LHSC - University Campus
London, Ontario, Canada, L6S 0E2
Actively Recruiting
Research Team
A
Ana Olteanu
CONTACT
R
Robyn Garrels-Lierman
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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