Patients with Crohn’s disease may require difficult surgeries in their lifetimes that typically involve the removal of diseased bowel. Some patients may end up with a permanent ileostomy – a surgical procedure to divert stool from the intestine after removing part of, or the whole, colon.
This can be a negative emotional experience, often leaving patients to face a lifetime of physical, dietary and psychological restrictions. And to this point, they have been excluded from clinical trials for new treatments, leaving them with little hope of effective treatment.
Now that’s about to change.
Western University and the Cleveland Clinic in Ohio have been awarded a $6.5 million grant from the Helmsley Charitable Trust to build a consortium to develop clinical trial outcome tools for patients with Crohn's disease living with a permanent ileostomy.
The new Endpoint Development for Ostomy Clinical Trial (EndO-trial) Consortium will help patients at London Health Sciences Centre (LHSC) and the Cleveland Clinic by developing better care pathways, as well as a drug development pathway for patients with Crohn's disease who have undergone this procedure.
“We are extremely grateful to the Helmsley Charitable Trust for their support of this interdisciplinary research to improve the lives of patients with Crohn's disease," said Dr. Vipul Jairath, gastroenterologist at LHSC and Scientist at Lawson Research Institute. “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.”
The consortium has several workstreams which will bring together patients, gastroenterologists, surgeons, stoma care nurses, dieticians and experts in clinical trial methods internationally. These workstreams include a consensus on optimal clinical care pathways; engagement with patients to understand their unmet needs of living with a stoma to help prioritize research questions; and development of a novel patient reported outcome tool and an endoscopy scoring tool.
“Ultimately this initiative will positively impact patients with Crohn’s disease by optimizing care, bringing treatments to patients with subtypes of disease that have been traditionally underserved, and ultimately reduce disease-related complications and improve quality of life,” said Jairath, who is also professor of Medicine at Schulich School of Medicine & Dentistry and the John and Susan McDonald Endowed Chair in Inflammatory Bowel Disease (IBD) Clinical Research at Western University.
“This is a large unmet need,” said Dr. Florian Rieder, PhD, vice chair and IBD co-section head in Cleveland Clinic's Department of Gastroenterology, Hepatology and Nutrition. “By providing novel outcome measures for a clinical trial, we can assess the efficacy of the therapies we are currently utilizing in patients with permanent ileostomy. The Helmsley Charitable Trust has 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."
Patients with Crohn’s disease will have the opportunity to take part in these studies in the near future at LHSC and the Cleveland Clinic, as well as several other centres in Canada and the U.S.