Endoscopic scoring system and patient questionnaire for people with Crohn's disease and a permanent ileostomy.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational project will enroll about 50 adults with Crohn's disease and a permanent end ileostomy who are scheduled for routine ileoscopy. Video recordings of those ileoscopies will be centrally read to identify endoscopic features across a range of inflammation and to develop an Endoscopic Index. Participants will also complete interviews to capture the symptoms and daily-life impacts that matter most, forming a Patient-Reported Outcome measure. The resulting EI and PRO are intended to enable inclusion of ileostomy patients in future clinical trials and improve outcome measurement for this population.

Why it matters

Who can join: the full rules

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.

Where it's running

• Mayo Clinic- Rochester
  Rochester, Minnesota, United States Recruiting
• Washington University in St Louis School of Medicine
  St Louis, Missouri, United States Recruiting
• Cleveland Clinic Foundation
  Cleveland, Ohio, United States Recruiting
• McMaster University Medical Centre
  Hamilton, Ontario, Canada Recruiting
• LHSC - University Campus
  London, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Florian Rieder — The Cleveland Clinic
• Study coordinator: Ana Olteanu
• Email: ana.olteanu@alimentiv.com
• Phone: 416-704-7734

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.