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

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

This project will try a new endoscopic scoring system and a patient questionnaire to measure inflammation and symptoms in adults with Crohn's disease who have a permanent ileostomy.

Quick facts

• Study type: Observational
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Alimentiv Inc. (Academic / other)
• Locations: 5 sites (Rochester, Minnesota and 4 other locations)
• Trial ID: NCT06670638 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults (≥18) with Crohn's disease who had a permanent end ileostomy at least 12 months ago, can read and speak English, and are planning an ileoscopy as part of routine care.

Not a fit: People without a permanent end ileostomy (including pouch, loop, continent ileostomy, colostomy, or temporary stomas), non-English speakers, and those not having a scheduled ileoscopy are unlikely to benefit.

Why it matters

Potential benefit: If successful, these tools could allow people with permanent ileostomies to join clinical trials and provide better measures to guide their treatment.

How similar studies have performed: Validated endoscopic scores and PROs exist for Crohn's disease with intact bowel, but applying and validating these kinds of tools specifically for patients with permanent ileostomies is novel and not yet established.

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.

Where this trial is running

Rochester, Minnesota and 4 other locations

• 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

Conditions Crohns Disease