Crohn'sRecruiting
Development of a Novel Endoscopic Index and Patient-reported Outcome Measure for Clinical Trials in Participants With Permanent Ileostomy
Observational · No treatment assigned · 5 sites · Alimentiv Inc.
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Crohns Disease. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- 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).
Plus 2 more requirement(s). There are also 10 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 50 participants are expected to take part.
- Start date: 2024-06-19.
- Main results expected around 2026-06-30 (estimate from the record).
- 5 study sites listed (5 marked recruiting) in Canada and United States.
Main thing being measured
- Develop a PRO instrument for patients with Crohn's Disease and Permanent Ileostomy (through study completion, and average of 1 year)
In the researchers’ words
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 is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Crohns Disease |
| Lead sponsor | Alimentiv Inc. |
| Collaborators | University of Western Ontario, Canada; The Leona M. and Harry B. Helmsley Charitable Trust; The Cleveland Clinic; OPEN Health (Pharmerit) |
| Enrollment | 50 (estimated) |
| Start date | 2024-06-19 |
| Primary completion (est.) | 2026-06-30 |
| First posted | 2024-11-01 |
| Last updated | 2025-11-12 |
| Official title | Development of a Novel Endoscopic Index and Patient-reported Outcome Measure for Clinical Trials in Participants With Permanent Ileostomy |
| ClinicalTrials.gov ID | NCT06670638 |
Interventions
- None listed
Full eligibility criteria (from the record)
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.
Locations (5)
| Site | City | Country | Site status |
|---|---|---|---|
| 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 |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.