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

NCT06670638

This study is recruiting at 3 US sites in 3 states, according to its ClinicalTrials.gov record last updated .

Summary

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.

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

  • Crohns Disease

Eligibility basics and study details

Study type
Observational
Phase
Not applicable
Ages
18 years and older
Sex
All
Healthy volunteers
Not accepted
Sponsor
Alimentiv Inc.
Last updated on ClinicalTrials.gov
November 12, 2025

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites

Minnesota · 1

  • Mayo Clinic- Rochester · Rochester, MN

Missouri · 1

  • Washington University in St Louis School of Medicine · St Louis, MO

Ohio · 1

  • Cleveland Clinic Foundation · Cleveland, OH

Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.