Cleveland Clinic and the University of Western Ontario have been awarded a $4.9 million grant from Helmsley Charitable Trust to build a consortium to develop clinical trial outcome tools for patients with Crohn's disease and permanent ileostomy.
A permanent ileostomy is a surgical procedure to divert stool from the intestine after removing part of or the whole colon. The new Endpoint Development for Ostomy Clinical Trial (EndO-trial) Consortium seeks to develop more effective drugs for patients with Crohn's disease who have undergone this procedure. The consortium will create tools to measure treatment outcomes in these patients, including a patient-reported outcome tool and permanent ileostomy endoscopy index.
"The overall goal is to improve disease management by establishing the best treatment strategies for these patients – but clinicians and researchers need to know how to measure success," says Florian Rieder, MD, Vice Chair and IBD Co-Section Head in Cleveland Clinic's Department of Gastroenterology, Hepatology and Nutrition, within the Digestive Disease & Surgery Institute.
"We are extremely grateful to the Helmsley Charitable Trust for their continuing support of our interdisciplinary research and collaborations to improve the lives of patients with Crohn's disease," says Dr. Rieder, also an investigator in the Department of Inflammation & Immunity. "They have once again provided an invaluable opportunity to bring together expertise in uncharted territory to tackle the unmet research needs in the study of Crohn's disease."
Although progress has been made in combating gut inflammation with several new drugs, patients with a permanent ileostomy have been universally excluded from clinical trials that evaluate new treatments.
"This is a big unmet need," says Vipul Jairath, MBChB, DPhil, MRCP, FRCPC, a physician-scientist and Western University's lead investigator on the grant. "By providing novel outcome measures for a clinical trial, we can statistically assess the efficacy of the therapies we are currently utilizing in patients with permanent ileostomy."
This is the fourth grant the Cleveland Clinic has received from the Leona M. and Harry B. Helmsley Charitable Trust in the past five years to accelerate the study and development of therapies for Crohn's disease.
The Helmsley Charitable Trust's Crohn's Disease Program supports impactful ideas and mobilizes a global community committed to improving the lives of Crohn's disease patients while pursuing a cure. The trust is also supporting Cleveland Clinic research through multiple initiatives in the STAR Consortium.