Endoscopy Measures for Crohn's Disease with Ileostomy

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

Recruiting Observational Study
Crohns Disease
No Study Drug Researchers observe your health over time — no experimental treatment is given.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
50 (estimated)
Sponsor
Alimentiv Inc. · Other
Who this trial is looking for

This trial is looking for adults with Crohn's Disease who have had surgery for a permanent ileostomy. Participants will help develop tools to measure their symptoms and will participate in routine medical procedures.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am at least 18 years old.
  • I have Crohn's Disease and had an ileostomy surgery at least a year ago.
  • I plan to have an ileoscopy as part of my routine medical care.
  • I can read, write, speak, and understand English.
  • I am willing to take part in all aspects of this study.
  • I can provide written consent to participate.

You may not be able to join if

  • I have any type of stoma that is not considered permanent.
  • I have serious skin problems around my stoma.
  • I have conditions that prevent me from having an ileoscopy.
  • I have any draining fistula.
  • I have a known small bowel stricture or have had trouble passing an endoscope recently.
  • I have an active Clostridoides difficile infection.
  • I have short bowel syndrome.
  • I have other serious health issues that may affect my participation.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

Answer a few quick questions to see if you may meet the eligibility requirements.

Check Your Eligibility
About This Trial
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 …
Trial Locations
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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 p…
Contacts

Ana Olteanu

416-704-7734

ana.olteanu@alimentiv.com

CONTACT

Robyn Garrels-Lierman

642-204-2047

robyn.garrels@alimentiv.com

CONTACT