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NCT Number: NCT06670638

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

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.

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Key information

Conditions

Crohns Disease Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

McMaster University Medical Centre, Hamilton, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Planning to have an ileoscopy procedure scheduled as part of routine medical care.
  • 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).
  • Able and willing to participate fully in all aspects of this study.
  • Written informed consent must be obtained and documented.

Exclusion criteria

  • 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).
  • Peristomal skin complications such as pyoderma gangrenosum, abscess, or any other severe peristomal skin inflammation.
  • 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.
  • Any actively draining fistula (eg, peristomal or peri-anal).
  • Evidence of a known small bowel stricture on cross-sectional imaging or inability to pass an endoscope within the past 6 months.
  • Known active Clostridoides difficile or other enteric infection.
  • Short bowel syndrome.
  • Predominant symptom(s) arising from a retained rectal stump.
  • 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.
  • Prior enrolment in the current study.

Treatment and study plan

Primary outcomes

  1. Develop a PRO instrument for patients with Crohn's Disease and Permanent Ileostomy

    Time frame: through study completion, and average of 1 year

    Concept elicitation interviews focusing on the symptoms and impacts relevant to patients with CD and permanent ileostomy will be conducted and used to develop a PRO. Cognitive interviews will subsequently be conducted to determine respondent comprehension and relevance of the items.

  2. Evaluate the intrarater reliability of 100-mm VAS.

    Time frame: At baseline and 2 weeks

    Central readers will score endoscopy videos using the VAS, on 2 separate occasions at least 2 weeks apart. Intrarater reliability will be quantified using ICC, which are equivalent to weighted Kappa statistics in the case of ordinal data.

  3. Evaluate the intrarater reliability of RAM identified items.

    Time frame: At baseline and 2 weeks

    Central readers will score endoscopy videos for items identified during a RAND/UCLA appropriateness method, on 2 separate occasions at least 2 weeks apart. Intrarater reliability will be quantified using ICC, which are equivalent to weighted Kappa statistics in the case of ordinal data.

  4. Evaluate the intrarater reliability of Rutgeerts score and its component items.

    Time frame: At baseline and 2 weeks

    Central readers will score endoscopy videos using the Rutgeerts Score, on 2 separate occasions at least 2 weeks apart. Intrarater reliability will be quantified using ICC, which are equivalent to weighted Kappa statistics in the case of ordinal data.

  5. Evaluate the intrarater reliability of CDEIS and its component items.

    Time frame: At baseline and 2 weeks

    Central readers will score endoscopy videos using the CDEIS, on 2 separate occasions at least 2 weeks apart. Intrarater reliability will be quantified using ICC, which are equivalent to weighted Kappa statistics in the case of ordinal data.

  6. Evaluate the intrarater reliability of SES-CD and its component items.

    Time frame: At baseline and 2 weeks

    Central readers will score endoscopy videos using the SES-CD, on 2 separate occasions at least 2 weeks apart. Intrarater reliability will be quantified using ICC, which are equivalent to weighted Kappa statistics in the case of ordinal data.

  7. Evaluate the interrater reliability of 100-mm VAS.

    Time frame: At baseline

    Central readers will score endoscopy videos using the VAS, on 2 separate occasions at least 2 weeks apart. Interrater reliability will be quantified using ICC, which are equivalent to weighted Kappa statistics in the case of ordinal data.

  8. Evaluate the interrater reliability of RAM identified items.

    Time frame: At baseline

    Central readers will score endoscopy videos for items identified during a RAND/UCLA appropriateness method, on 2 separate occasions at least 2 weeks apart. Interrater reliability will be quantified using ICC, which are equivalent to weighted Kappa statistics in the case of ordinal data.

  9. Evaluate the interrater reliability of Rutgeerts score and its component items.

    Time frame: At baseline

    Central readers will score endoscopy videos using the Rutgeerts score, on 2 separate occasions at least 2 weeks apart. Interrater reliability will be quantified using ICC, which are equivalent to weighted Kappa statistics in the case of ordinal data.

  10. Evaluate the interrater reliability of CDEIS and its component items.

    Time frame: At baseline

    Central readers will score endoscopy videos using the CDEIS, on 2 separate occasions at least 2 weeks apart. Interrater reliability will be quantified using ICC, which are equivalent to weighted Kappa statistics in the case of ordinal data.

  11. Evaluate the interrater reliability of SES-CD and its component items.

    Time frame: At baseline

    Central readers will score endoscopy videos using the SES-CD, on 2 separate occasions at least 2 weeks apart. Interrater reliability will be quantified using ICC, which are equivalent to weighted Kappa statistics in the case of ordinal data.

  12. Develop a novel index using a multiple regression approach with the dependent variables being the VAS and candidate independent variables including items having at least moderate interrater reliability.

    Time frame: through study completion, and average of 1 year

    A prototype index will be created using the VAS for global assessment of severity as the dependent criterion. Prospective validation of the endoscopic index will be performed in a future initiative outside of the scope of this study.

Study contacts

Contact information is provided by the study sponsor or research team.

Ana Olteanu

CONTACT

[email protected]

416-704-7734

Robyn Garrels-Lierman

CONTACT

[email protected]

642-204-2047

Sponsors and collaborators

Lead sponsor

Alimentiv Inc.

Other

Collaborators

  • OPEN Health (Pharmerit)
  • The Cleveland Clinic
  • The Leona M. and Harry B. Helmsley Charitable Trust
  • University of Western Ontario, Canada

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Nov 1, 2024
Registry last updated
Nov 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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