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Updated: Aug 11, 2025
Murine Ileocolic Bowel Resection with Primary Anastomosis
Published on: October 29, 2014
Patients With Crohn's Disease and Permanent Ileostomy Are Universally Excluded From Clinical Trials: A Systematic
Sudheer K Vuyyuru1, Florian Rieder2,3, Virginia Solitano1
1Division of Gastroenterology, Department of Medicine, Schulich School of Medicine, Western University, London, Ontario, Canada.
Introduction:
We performed a systematic review to investigate whether patients with Crohn's disease (CD) and permanent ileostomy (PI) have been included in clinical trials evaluating biologics and small molecules.
Methods:
MEDLINE, Embase and Cochrane library (CENTRAL) data bases were searched from inception to May 16, 2022 for placebo controlled induction and/or maintenance randomized controlled trials assessing biologics and oral small molecules in adult patients with active CD.
Results:
Of the 81 induction and maintenance trials assessing biologics and oral small molecules in CD, none permitted the enrollment of patients with PI. Patients with CD and PI have been universally excluded from pharmaceutical trials of biologics and small molecules to date.
Discussion:
There is an urgent need to identify barriers to enrollment and develop eligibility and outcome measures enabling the inclusion of patients with CD and PI into clinical trials.
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