New study aims to give ileostomy patients a voice in Crohn's trials
NCT ID NCT06670638
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study involves about 50 adults with Crohn's disease who have a permanent ileostomy (a surgically created opening in the belly to pass waste). The goal is to create new tools—a patient questionnaire and an endoscopic scoring system—to accurately measure disease activity in this group. Currently, these patients are often left out of clinical trials because there are no good ways to track their condition. By developing these tools, researchers hope to include them in future studies for new treatments.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2024
- Expected to finish
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Feb 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Approximately 50 participants who meet the inclusion and exclusion criteria will be enrolled in the study. The study population will ideally include approximately equal distributions of participants with disease activity categorized by a central reader as normal, mild, moderate, and severe, according to the VAS assessment. It is not possible to predetermine the number of participants with specific disease activity levels. The distribution of inflammatory disease activity across the study population will be monitored on an ongoing basis and recruitment strategies may be reviewed for opportunities to help maintain a balanced distribution. No more than 10 asymptomatic participants will be enrolled.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
5 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Cleveland Clinic Foundation
RECRUITINGCleveland, Ohio, 44195, United States
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LHSC - University Campus
RECRUITINGLondon, Ontario, L6S 0E2, Canada
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Mayo Clinic- Rochester
RECRUITINGRochester, Minnesota, 55905, United States
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McMaster University Medical Centre
RECRUITINGHamilton, Ontario, L6S 0E2, Canada
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Washington University in St Louis School of Medicine
RECRUITINGSt Louis, Missouri, 63110, United States
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