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
34 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
Researchers are developing new tools to better understand and measure symptoms and disease activity in patients with Crohn's 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.
CONDITIONS
Brief 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 aged 18 years or older with Crohn's Disease
- Have had subtotal colectomy or proctocolectomy and permanent end ileostomy at least 12 months before the scheduled endoscopy
- Planning to have an ileoscopy procedure as part of routine medical care
- Proficient in English to participate in interviews without an interpreter
- Able and willing to fully participate in all parts of the study
- Provide written informed consent
You will not qualify if you...
- Having end or loop colostomy, end ileostomy for ulcerative colitis, continent ileostomy, ileal pouch anal anastomosis, or any type of ileostomy not permanent at enrollment
- Having severe peristomal skin complications like pyoderma gangrenosum or abscess
- Conditions preventing ileoscopy such as stomal stenosis, small bowel stricture, major stoma prolapse, symptomatic parastomal hernia, or severe peristomal skin irritation
- Having any actively draining fistula
- Known small bowel stricture on imaging or inability to pass an endoscope within past 6 months
- Active Clostridoides difficile or other enteric infection
- Short bowel syndrome
- Predominant symptoms from a retained rectal stump
- Serious underlying diseases affecting ability to participate or describe symptoms
- Previous enrollment in this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At baseline
Participants undergo ileoscopy procedures as part of routine medical care to assess their condition.
1 visit (in-person)
Duration - Approximately 1 year
Participants are observed over an average of 1 year to develop and evaluate patient-reported outcome measures and novel indexes related to Crohn's Disease and permanent ileostomy.
Follow-up assessments as scheduled
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
R
Robyn Garrels-Lierman
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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